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510(k) Data Aggregation
(204 days)
Better Care Plastic Technology Co., Ltd.
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05. The gloves are single use, disposable, and provided non-sterile.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The device in question is "Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K242533).
Non-Clinical Performance Data
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions (Length) | Min 220mm for size XS, S; Min 230mm for size M-XXL | Pass |
| ASTM D6319-19 | Physical Dimensions (Palm Width) | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L:110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions (Thickness) | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16 | Physical Properties (Tensile Strength & Elongation) | Tensile Strength (Min 14 MPa); Elongation (Before Aging 500% min and after aging 400% min) | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 | Permeation by Chemotherapy Drugs | As specified in the table for each drug (e.g., >240 minutes for most, with specific lower values for Carmustine and Thiotepa, explicitly stating "Do not use" for these). | Pass (as per specific BDTs) |
| ISO 10993-5:2009 | Cytotoxicity | No cytotoxicity reactivity (Note: The device states it is cytotoxic but this concern was addressed by acute systemic toxicity testing.) | The test article scored '4' at 24, 48, and 72 ± 4 hours and is considered cytotoxic under the conditions of this test. Cytotoxicity concern was addressed by acute systemic toxicity testing. |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No skin sensitization and Skin irritation | Under the conditions of this study, there were no evidence of sensitization and irritation. |
| ISO 10993-11:2017 | Acute systemic toxicity study | No adverse biological reaction | Under the conditions of this study, there was no evidence of acute systemic toxicity. |
Clinical Performance Data
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Modified DRAIZE-95 Test to Evaluate Low Dermatitis Potential of Medical Gloves | Demonstrate a reduced potential for sensitizing users to chemical additives. | Under the conditions of this clinical trial, the subject device demonstrated reduced potential for sensitizing users to chemical additives. |
Study Information
Due to the nature of the device (patient examination gloves) and the provided documentation, several sections of your request are not directly applicable or explicitly detailed. This document is a 510(k) summary for a Class I medical device, which typically relies more on performance testing against established standards and equivalence to predicates rather than complex clinical trials like those for novel therapeutic devices.
Here's what can be extracted from the document:
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Permeation Tests (ASTM D6978-05): The document does not specify the exact sample size used for the permeation tests for each chemical. The standard ASTM D6978-05 typically outlines the number of replicates required (e.g., three specimens).
- Biocompatibility Tests (ISO 10993 series): Similarly, the sample sizes for these tests are not explicitly stated in the summary but would be specified by the respective ISO standards.
- Clinical Test (Modified DRAIZE-95 Test): A 305-subject study was completed. The country of origin and whether it was retrospective or prospective is not specified, but such a test is typically prospective to evaluate a new or modified device.
- Data Provenance: The document generally refers to testing "under the conditions of this study," without specifying the country of origin for non-clinical tests. The manufacturer is based in China.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the non-clinical tests (physical properties, chemical permeation, biocompatibility), the "ground truth" is established by the standardized methods themselves (ASTM and ISO standards) and objective measurements by qualified laboratory personnel. The number of "experts" and their specific qualifications beyond standard lab certifications are not typically detailed in these summaries.
- For the clinical test on dermatitis potential, the "ground truth" is derived from the subjects' reactions as evaluated by the study investigators. The qualifications of these investigators are not provided.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For the non-clinical tests, adjudication methods like 2+1 or 3+1 are not applicable. Results are based on objective measurements against defined criteria.
- For the clinical test (Modified DRAIZE-95), the document does not specify an adjudication method. Clinical studies of this nature usually involve clinical investigators observing and documenting reactions, and a statistical analysis of the aggregate results.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a physical product (gloves), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Physical and Chemical Tests: The ground truth is based on the objective measurements of the glove's properties (dimensions, strength, elongation, watertightness, powder residue) and breakthrough detection times for chemicals, all conducted according to recognized ASTM and ISO standards.
- Biocompatibility Tests: Ground truth is determined by the biological response observed in in vitro (cytotoxicity) or in vivo (irritation, sensitization, acute systemic toxicity) models as interpreted against the acceptance criteria of the ISO 10993 standards.
- Dermatitis Potential Clinical Test: The ground truth is the observed clinical reactions of human subjects to the device, evaluated against criteria for allergic contact sensitization.
-
The sample size for the training set:
- Not applicable. This pertains to an algorithm or machine learning model. This device is a physical product.
-
How the ground truth for the training set was established:
- Not applicable. As above, this is for an algorithm or machine learning model.
Ask a specific question about this device
(95 days)
Better Care Plastic Technology Co., Ltd.
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
The provided document describes the acceptance criteria and performance of "Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." It is important to note that this is a 510(k) summary for a medical device (gloves), not an AI/algorithm-driven device. Therefore, many of the requested fields related to AI clinical studies, such as sample sizes for AI test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable.
The studies described are non-clinical performance tests for the gloves themselves, not an AI system.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions - Length (ASTM D6319-19) | Min 220mm for size XS, S; Min 230mm for size M-XXL | Pass |
| Physical Dimensions - Palm Width (ASTM D6319-19) | XS: 70±10 mm; S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm; XXL: 130±10 mm | Pass |
| Physical Dimensions - Thickness (ASTM D6319-19) | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| Physical Properties (ASTM D6319-19, ASTM D412-16(2021)) | Tensile Strength (Min 14 MPa); Elongation (Before Aging 500% min and After Accelerated Aging 400% min) | Pass |
| Water Leak Test (ASTM D6319-19, ASTM D5151-19) | AQL 2.5 (ISO 2859-1) | Pass |
| Powder Residue (ASTM D6319-19, ASTM D6124-06 (2017)) | Max 2mg/glove | Pass |
| Permeation by Chemotherapy Drugs (ASTM D6978-05 (2019)) | Refer to the detailed table (reproduced below) | Pass |
| Irritation and Skin Sensitization (ISO 10993-10:2010) | Is non-sensitization and non-irritation | Is non-sensitization and Non-irritation |
| Cytotoxicity (ISO 10993-5:2009) | Cytotoxicity reactivity | showed potential toxicity to L929 cells (Note: addressed by acute systemic toxicity testing) |
| Acute Systemic Toxicity Study (ISO 10993-11:2017) | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity |
Detailed Chemotherapy Drug Permeation and Fentanyl Citrate Comparison Claim (Subject device K232266 performance):
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 22.8 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.9 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade, 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Warning: Do not use with Carmustine (22.8 minutes) and Thiotepa (46.9 minutes).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify general "sample sizes" for the test set in terms of medical images or patient data. Instead, it refers to standardized testing methodologies for physical and chemical properties of gloves. For instance, ASTM D5151 for water leak test would involve a certain number of gloves per batch as per AQL (Acceptable Quality Limit) standards, but the specific quantity is not stated in this summary. The data provenance is generally implied to be from laboratory testing conforming to the cited ASTM and ISO standards. The country of origin of the device manufacturer is China. These are prospective tests performed on the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI or diagnostic device that requires expert ground truth for interpretation of medical images or patient data. The "ground truth" for the device's performance is established by the specified pass/fail criteria of the ASTM and ISO standards for glove manufacturing and material properties. The tests are laboratory-based and measure physical/chemical attributes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human interpretation of data, typically in diagnostic or screening studies, not for the physical and chemical testing of medical gloves.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on standardized test methods and predetermined acceptance criteria defined by international and national standards organizations such as ASTM and ISO. These standards dictate acceptable physical dimensions, mechanical properties, chemical permeation resistance, and biological safety (e.g., irritation, sensitization, systemic toxicity) for medical examination gloves. For instance, for chemotherapy drug permeation, the "ground truth" is the measured breakthrough detection time according to ASTM D6978-05(2019).
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As this is not an AI device, there is no "training set" or ground truth established in that context.
Ask a specific question about this device
(91 days)
Better Care Plastic Technology Co., Ltd.
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019).
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property within landfills tested per ASTM D5511.
The provided text describes the acceptance criteria and study results for "Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)".
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Length | Minimum 220mm for size XS-S; Minimum 230mm for size M-XXL | Pass |
| ASTM D6319-19 | Physical Dimensions Palm Width | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions Thickness | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min 14 Mpa); Elongation (Before Aging 500% and after aging 400% Min) | Pass |
| ASTM D6319-19, ASTM D5151-19 | Freedom from holes | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | ≤ 2 mg per glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs and Fentanyl Citrate | Minimum Breakthrough Detection Time (BDT) for various drugs (as detailed in the tables below) | Pass (for claimed drugs) |
| ISO 10993-10 & 23:2021 | Irritation and Skin Sensitization | Non-sensitization and Non-irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity (no specific acceptance criteria listed, but result indicates toxicity) | showed potential toxicity to L929 cells. |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity. |
| ISO 11737-1:2018 | Open box bioburden study | No significant increase in bioburden | Pass |
Chemotherapy Drug and Fentanyl Citrate Permeation Performance:
Black Glove:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 23.0 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 45.9 |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
Green Glove:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 15.4 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 34.4 |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
Warnings: Do not use with Carmustine and Thiotepa due to extremely low permeation times.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the specific sample sizes for each test in the acceptance criteria. However, compliance with ASTM and ISO standards for products like medical gloves typically involves defined sample sizes for testing (e.g., AQL levels for freedom from holes). The data provenance is not specified, but the testing was conducted to international standards (ASTM, ISO). Given this is a 510(k) submission for a physical device (gloves), the testing is prospective, performed on the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This device is a physical product (medical gloves) and its performance is evaluated against engineering and material standards (ASTM, ISO), along with chemical permeation resistance. There is no human interpretative element requiring expert consensus or ground truth in the way medical imaging AI devices do. The "ground truth" here is the result of standardized physical and chemical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As this is not an AI/diagnostic device, there is no adjudication process involving human experts to establish ground truth from data.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI medical device. The tests performed are standalone in the sense that the device itself is subjected to a test, and its performance is measured directly against predefined criteria without human intervention in the result determination beyond operating the testing equipment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by standardized laboratory testing protocols and predefined limits specified in international standards (ASTM D6319-19, ASTM D6978-05 (2019), ISO 10993 series, etc.). For example, the minimum tensile strength, elongation percentages, AQL for holes, and breakthrough detection times for chemicals are directly measured and compared against the specified numerical criteria from these standards.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for this type of device, this question is not relevant.
Ask a specific question about this device
(126 days)
Better Care Plastic Technology Co., Ltd.
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate and select other drugs in accordance with ASTM D6978.
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small. Medium. Large. Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property within landfills tested per ASTM D5511.
The acceptance criteria for the Biodegradable Nitrile Powder Free Examination Gloves and their reported performance are detailed in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions - Length | Minimum 220mm for size XS and S; 230mm for Size M, L, XL, XXL | Pass |
| ASTM D6319-19 | Physical Dimensions - Palm Width | XS: 70 ± 10mm; S: 80 ± 10mm; M: 95 ± 10mm; L: 110 ± 10mm; XL: 120 ± 10mm; XXL: 130 ± 10mm | Pass |
| ASTM D6319-19 | Physical Dimensions - Thickness | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16 (2021) | Physical Properties (Tensile Strength & Elongation) | Tensile Strength (Min 14 Mpa) and Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs, Fentanyl Citrate and select other drugs | Refer to the detailed tables for specific drugs and minimum breakthrough detection times (BDT) – generally >240 minutes for most drugs, with exceptions for Carmustine (11.8 min) and Thio Tepa (33.5 min) | Pass (Meets or exceeds specified BDTs, with noted exceptions) |
| ISO 10993-10 & 23:2021 | Irritation and Skin Sensitization | Skin sensitization and Skin irritation | Non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | Showed potential toxicity to L929 cells, but this difference does not raise different questions of safety and effectiveness compared to the predicate device. |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | No evidence of acute systemic toxicity. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the exact sample sizes for each test mentioned (e.g., number of gloves tested for each specific drug permeation, or for physical properties). However, it references established ASTM and ISO standards for these tests. These standards typically define the sampling plans and statistical requirements for demonstrating compliance. The data provenance is derived from non-clinical laboratory testing (in-vitro studies) performed by the manufacturer or a contracted lab, rather than human test subjects or clinical data. There is no information on the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The device is an examination glove, and its performance is evaluated through standardized physical, chemical, and biological tests (e.g., ASTM D6319, ASTM D6978, ISO 10993 series). The "ground truth" for these tests is established by the well-defined methodologies and acceptance criteria outlined in these international standards, not by expert consensus on clinical findings.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation tasks where human readers' opinions are combined to establish a ground truth. For the non-clinical performance testing of a medical device like examination gloves, the determination of compliance is based on objective measurements against established standard criteria, not on adjudicating expert opinions.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. No MRMC study was conducted as this device is an examination glove, not an AI-assisted diagnostic tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is an examination glove, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used
The "ground truth" for the performance evaluation of these gloves is based on standardized test methodologies and their defined acceptance criteria. This includes:
- Physical performance standards: ASTM D6319-19 for mechanical properties like length, palm width, thickness, tensile strength, and elongation.
- Leakage detection standards: ASTM D5151-19 for watertight integrity.
- Chemical permeation standards: ASTM D6978-05 (2019) for breakthrough detection time of chemotherapy drugs and other chemicals.
- Biocompatibility standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-11 (acute systemic toxicity), and ISO 10993-23 (skin irritation).
These standards provide objective, measurable criteria for the device's performance.
8. The sample size for the training set
This section is not applicable. The document describes the non-clinical performance testing of a physical medical device (examination gloves), not an AI or machine learning model. Therefore, there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
This section is not applicable, as there is no training set for this device.
Ask a specific question about this device
(238 days)
Better Care Plastic Technology Co., Ltd
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate.
Powder Free Nitrile Examination Glove (Grev) Tested for Use with Chemotherapy Drugs and Fentany) Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large, Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
The document is a US FDA 510(k) premarket notification for "Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K223713). It is not a report on a study proving a device meets acceptance criteria for an AI/ML medical device, but rather a submission for a physical medical device (gloves).
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, including details like "sample size used for the test set," "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone (algorithm only) performance," cannot be extracted from this document, as it discusses the physical properties and chemical permeation resistance of examination gloves.
The tables in the document describe the performance of the gloves against various chemotherapy drugs and Fentanyl Citrate, and their physical properties and biocompatibility.
Here's the closest interpretation of the request using the provided document's context of a physical device:
Acceptance Criteria and Device Performance (for Examination Gloves)
This document describes the testing and acceptance criteria for Powder Free Nitrile Examination Gloves. The "Acceptance Criteria" refer to the performance standards the gloves must meet to be considered safe and effective for their indicated use, especially concerning resistance to chemotherapy drugs and fentanyl citrate. The "Reported Device Performance" shows the results for the applicant's specific glove product.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides these in a combined table under "Summary of Non-Clinical Performance Data" and "Technological Characteristic Comparison Table: Chemotherapy Permeation and Fentanyl Citrate Comparison Claim."
Non-Clinical Performance Data Summary (from page 10):
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL | Pass |
| ASTM D6319-19 | Physical Dimensions Palm Width | XS: 70±10mm, S: 80±10mm, M: 95±10mm, L:110±10mm, XL: 120±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions Thickness | Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16 (2021) | Physical Properties | Tensile Strength (Min 14 MPa), Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water leak test | G-I, AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs | Refer to table of specific drug breakthrough times | Pass (See details below for specific drugs) |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | No Cytotoxicity reactivity | showed potential toxicity to L929 cells.* |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity. |
*Note on Cytotoxicity: The document states "showed potential toxicity to L929 cells" for cytotoxicity but then indicates "Cytotoxicity concern was addressed by acute systematic toxicity testing" in the comparison table (page 6), where the Acute Systematic Toxicity test result was "no evidence of systemic toxicity." This implies the potential in vitro toxicity was deemed acceptable given no in vivo systemic toxicity.
Chemotherapy Drug and Fentanyl Citrate Permeation (pages 5 & 6 and 8 & 9):
The acceptance criterion for most drugs is a minimum breakthrough detection time, often stated as ">240 minutes". The reported device performance is presented alongside the predicate and reference devices.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) (Subject Device K223713) |
|---|---|
| Arsenic Trioxide (1 mg/ml) | >240 |
| Azacitidine (25 mg/ml) | >240 |
| Bendamustine HCL (5 mg/ml) | >240 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Bortezomib (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Carfilzomib (2 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 13.9 |
| ... (many drugs listed as >240 minutes) ... | ... |
| Thiotepa (10 mg/ml) | 44.4 |
| ... (more drugs listed as >240 minutes) ... | ... |
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
| Simulated Gastric Acid Fluid/Fentanyl Citrate Mix 50/50 | >240 |
Important Note: The document explicitly states: "*Please note that the following drugs have extremely low permeation times: Carmustine: 13.9 minutes, Thio Tepa: 44.4 minutes. Warning: Do not use with Carmustine and Thio Tepa." This indicates that for these two specific drugs, the gloves do not meet a desired long-duration protection, and this is communicated as a warning on the label. For all other listed drugs, the glove achieved a breakthrough time of >240 minutes, meeting the implicit acceptance given the context of other drugs and the "Pass" result in the summary table.
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of gloves or individual tests) used for each physical, chemical permeation, or biocompatibility test. It only states "Non-clinical tests were conducted to verify that the proposed device met all design specifications."
- Data Provenance: The tests were conducted to specific ASTM and ISO standards. The manufacturer, Better Care Plastic Technology Co., Ltd, is located in China (Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China). The testing data would originate from their internal testing or third-party labs they commissioned. The document does not specify if the data is retrospective or prospective, but for such device testing, it is typically prospective, meaning the tests were performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the testing of physical gloves. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic AI/ML devices where human interpretation is the gold standard. For these gloves, the "ground truth" is established by direct physical and chemical measurements following globally recognized standards (ASTM, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for establishing consensus ground truth in medical image interpretation for AI/ML studies. Here, the results are direct measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. An MRMC study is for evaluating human performance (e.g., radiologists) with and without AI assistance for diagnostic tasks. This document is about the physical properties of medical gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This concept pertains to AI algorithms performing diagnostic tasks independently. The "device" here is a physical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance of the gloves is based on:
- Direct Physical Measurements: e.g., length, palm width, thickness, tensile strength, elongation, water leak rate, powder residue, all conducted according to specified ASTM standards.
- Chemical Permeation Testing: Direct measurement of breakthrough time for specific chemotherapy drugs and fentanyl citrate using ASTM D6978-05 (2019) standard.
- Biocompatibility Testing: In vitro cytotoxicity (ISO 10993-5), dermal irritation and skin sensitization (ISO 10993-10), and acute systemic toxicity (ISO 10993-11), where "ground truth" is determined by the specific biological responses observed as per the standard's criteria.
8. The sample size for the training set:
- Not applicable. There is no AI/ML model or "training set" for physical examination gloves.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical device.
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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
Here's a breakdown of the acceptance criteria and study information for the Nitrile Powder Free Examination Gloves, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Length | Minimum 230mm for all sizes | Pass |
| ASTM D6319-19 | Physical Dimensions Palm Width (XS, S, M, L, XL, XXL) | XS: 70±10mm, S: 80±10mm, M: 95±10mm, L:110±10mm, XL: 120±10mm, XXL: 130±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions Thickness (Finger, Palm) | Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16(2021) | Physical Properties (Tensile Strength, Elongation) | Tensile Strength (Min 14 MPa) and Elongation (Before Aging 500% and after aging 400%) Min AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs | Refer to the table below for specific drug BDTs | Pass (Based on individual BDTs) |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | No Cytotoxicity reactivity | showed potential toxicity to L929 cells. (Note: Cytotoxicity concern was addressed by acute systematic toxicity testing to still meet acceptance) |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of systemic toxicity |
Chemotherapy Drug and Fentanyl Citrate Permeation (Breakthrough Detection Time - BDT)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes (Acceptance Criteria) | Reported Device Performance (BDT in Minutes) |
|---|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | Explicit criteria not listed, but compared to predicate and results are 11.2 min, with a caution against use. | 11.2 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 (Implicitly, as predicate is >240 and proposed is same) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 (Implicitly) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 (Implicitly) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 (Implicitly) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 (Implicitly) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 (Implicitly) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 (Implicitly) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 (Implicitly) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | Explicit criteria not listed, but compared to predicate and results are 29.4 min, with a caution against use. | 29.4 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 (Implicitly) | >240 |
Note on Permeation Acceptance: For chemotherapy drugs where the predicate device showed ">240 minutes", the proposed device also achieving ">240 minutes" indicates it meets or exceeds the previous performance. For Carmustine and Thiotepa, while the BDT is lower, the acceptance is ultimately related to the explicit warning not to use them with these drugs, indicating that the observed breakthrough times are treated as insufficient for safe handling.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test against the acceptance criteria (e.g., number of gloves tested for each physical dimension, water leak, or permeation). However, it implies standardized testing according to relevant ASTM and ISO standards. The data provenance is industrial testing, most likely performed in a lab setting, to comply with the specified ASTM and ISO standards.
- Data Provenance: The device manufacturer, Better Care Plastic Technology Co., Ltd. (located in Shenze County, Hebei, China), would have overseen these tests, either internally or through a qualified testing laboratory. The data is thus of industrial origin, specifically from the manufacturer's testing or a third-party lab they used.
- Retrospective/Prospective: These are likely prospective tests conducted specifically for this 510(k) submission to demonstrate compliance with the standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for examination gloves is established by objective, standardized laboratory tests (e.g., measuring physical dimensions, tensile strength, breakthrough detection time for chemicals, biological reactivity as per ISO standards). It does not involve human expert consensus on interpretations of images or clinical outcomes.
4. Adjudication method for the test set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image-based diagnostic device evaluations where expert opinions need to be reconciled. For the physical and chemical testing of gloves, the results are quantitative measurements or direct observations (e.g., pass/fail for a water leak test) and do not require expert adjudication in the same sense.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. An MRMC study assesses the performance of human readers (e.g., radiologists, pathologists) in interpreting medical data, often with and without AI assistance, across a range of cases. This device (examination gloves) is a physical product and does not involve human readers or AI assistance in its primary function, nor in the testing performed for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question pertains to AI/algorithm performance. The device is a physical product, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance of these gloves is defined by:
- Standardized Test Methods and Specifications: Specific values and criteria (e.g., minimum tensile strength, maximum powder residue, minimum breakthrough detection time) defined by national and international standards like ASTM D6319-19, ASTM D6978-05, ISO 10993 series.
- Direct Measurement and Observation: The device's physical properties and chemical resistance are directly measured and observed in laboratory settings according to these established protocols.
- Biological Reactivity Endpoints: For biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity), the "ground truth" is determined by established biological endpoints and criteria within the ISO 10993 standards.
8. The sample size for the training set
This is not applicable. This question refers to the training data for an AI algorithm. This device is a physical medical product, and no AI algorithm development is described or relevant to its clearance.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes = Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
This document describes a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This is a Class I medical device, which means it is subject to general controls and does not require approval of a premarket approval application (PMA). The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K192954).
The acceptance criteria and study proving the device meets these criteria are based on non-clinical performance data, as no clinical performance data was provided or required for this device type.
Acceptance Criteria and Device Performance Study
The device's performance was evaluated against various ASTM and ISO standards for medical examination gloves, particularly focusing on their physical properties and resistance to permeation by chemotherapy drugs and Fentanyl Citrate.
1. Table of Acceptance Criteria and Reported Device Performance
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions: Length | Minimum 230mm for all sizes | Pass |
| ASTM D6319-19 | Physical Dimensions: Palm Width | XS: 70±10mm, S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: 120±10mm, XXL: 130±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions: Thickness | Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16(2021) | Physical Properties (Tensile Strength & Elongation) | Tensile Strength (Min 14 MPa), Elongation (Before Aging 500% min, After Aging 400% min), Min AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water Leak Test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs | Refer to specific Minimum Breakthrough Detection Time (BDT) for each drug (as listed in section "Chemotherapy Permeation and Fentanyl Citrate Comparison Claim" on pages 8-9 of the document). For most drugs, the criterion is >240 minutes, with the exception of Carmustine and Thio Tepa. | Pass (Results shown in detail in the provided tables in the document, page 2 and 5-6). For Carmustine: 11.1 min (met its specific criterion). For Thio Tepa: 21.6 min (met its specific criterion). Fentanyl Citrate Injection: >240 min. |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | Non-sensitizing and Non-irritating | Non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity evaluated | Showed potential toxicity to L929 cells (concern addressed by acute systematic toxicity testing). |
| ISO 10993-11:2017 | Acute Systemic Toxicity Study | No adverse biological reaction | No evidence of systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for water leaks, chemical permeation). However, the tests were conducted according to established industry standards such as ASTM and ISO, which typically define appropriate sample sizes for such evaluations.
The data provenance is based on non-clinical laboratory testing performed by or for Better Care Plastic Technology Co., Ltd. The owner's identification indicates their address as "Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China," suggesting the tests took place in China. The data is retrospective in the sense that it represents completed laboratory tests submitted for the 510(k) application.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided in the document. For non-clinical validation of gloves, "ground truth" is typically established by adherence to established test methodologies (ASTM, ISO standards) and the measured physical/chemical properties, rather than expert consensus on subjective evaluations. The "experts" would be the certified laboratories and technicians performing these standardized tests.
4. Adjudication Method for the Test Set
Not applicable. As described above, the validation involves standardized physical and chemical property testing, not subjective human evaluation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance. This document pertains to physical medical devices (examination gloves), for which MRMC studies are not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This question is not applicable to a physical medical device like an examination glove. The "performance" being evaluated is the glove's physical and chemicalbarrier properties, not an algorithm's output.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on objective, quantitative measurements obtained through standardized laboratory test methods (e.g., ASTM D6319-19 for physical dimensions, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993 series for biocompatibility). These standards define the acceptable range or threshold for a given property.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product (nitrile gloves), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
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Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.
Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-10(2015) and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2013).
This document is a 510(k) summary for the "Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)". It describes the device, its intended use, and comparative testing against a predicate device.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is primarily evaluated against two standards: ASTM D6319-10(2015) for Nitrile Examination Gloves (General Characteristics) and ASTM D6978-05(2013) for Chemotherapy Drug Permeation. Specific acceptance criteria are not explicitly stated for all parameters, but rather the performance of the proposed device is compared to the predicate device and relevant ASTM standards.
The table below summarizes the key performance characteristics and reported results. For characteristics not explicitly having acceptance criteria listed as a specific number, the "Comparison" column indicates if the device is "Same" or "Similar" to the predicate, implying it meets comparable performance.
| Test Parameter / Acceptance Criteria (as per ASTM standards or comparison) | Reported Device Performance (Proposed Device K182600) |
|---|---|
| General Characteristics (ASTM D6319-10(2015)) | |
| Length | Minimum 230mm |
| Palm Width (XS) | $70\pm10$ mm |
| Palm Width (S) | $80\pm10$ mm |
| Palm Width (M) | $95\pm10$ mm |
| Palm Width (L) | $110\pm10$ mm |
| Palm Width (XL) | $120\pm10$ mm |
| Thickness (Finger) | Minimum 0.05 mm |
| Thickness (Palm) | Minimum 0.05 mm |
| Tensile Strength, Before Aging | 14MPa, min |
| Ultimate Elongation, Before Aging | 500%, min |
| Tensile Strength, After Accelerated Aging | 14MPa, min |
| Ultimate Elongation, After Accelerated Aging | 400%, min |
| Freedom from holes (ASTM D 5151-06, AQL 2.5) | In accordance with ASTM D 5151-06, following ASTM D6319-10, G-1, AQL 2.5 |
| Powder-Content | $\le2$ mg per glove |
| Biocompatibility (ISO 10993) | |
| ISO 10993-10:2010 Skin Irritation Study | Not an irritant |
| ISO 10993-10:2010 Maximization Sensitization Study | Not a sensitizer |
| ISO 10993-5:2009 Cytotoxicity Test | Not a cytotoxic potential |
| Chemotherapy Drug Permeation (ASTM D6978-05(2013)) | Minimum Breakthrough Detection Time (Minutes) |
| Carmustine(BCNU) (3.3 mg/ml) | 11.0 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Dacarbazine (DTIC) (10mg/ml) | >240 |
| Doxorubicin Hydrochloride (2mg/ml) | >240 |
| Etoposide (Toposar) (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Paclitaxel (Taxol) (6mg/ml) | >240 |
| Thiotepa (THT) (10mg/ml) | 28.8 |
| Bleomycin (15.0mg/ml) | >240 |
| Busulfan (6.0mg/ml) | >240 |
| Carboplatin, (10.0mg/ml) | >240 |
| Chloroquine, (50.0mg/ml) | >240 |
| Cyclosporin, (100.0mg/ml) | >240 |
| Cytarabine, (100.0mg/ml) | >240 |
| Daunorubicin, (5.0mg/ml) | >240 |
| Docetaxel, (10.0mg/ml) | >240 |
| Epirubicin (Ellence), (2.0mg/ml) | >240 |
| Fludarabine, (25.0mg/ml) | >240 |
| Gemcitabine (Gemzar) (38.0mg/ml) | >240 |
| Idarubicin, (1.0mg/ml) | >240 |
| Ifosfamide, (50.0mg/ml) | >240 |
| Irinotecan, (20.0mg/ml) | >240 |
| Mechlorethamine HCI, (1.0mg/ml) | >240 |
| Melphalan, (5.0mg/ml) | >240 |
| Mitomycin C, (0.5mg/ml) | >240 |
| Mitoxantrone, (2.0mg/ml) | >240 |
| Oxaliplatin, (2.0mg/ml) | >240 |
| Paraplatin, (10.0mg/ml) | >240 |
| Retrovir, (10.0mg/ml) | >240 |
| Rituximab, (10.0mg/ml) | >240 |
| Topotecan HCL, (1.0mg/ml) | >240 |
| Trisonex, (1.0mg/ml) | >240 |
| Velcade (Bortezomib), (1.0mg/ml) | >240 |
| Vincristine, (1.0mg/ml) | >240 |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of gloves or test replicates) used for each individual test (e.g., tensile strength, freedom from holes, chemotherapy permeation). It references the ASTM standards, which typically define the appropriate sample sizes and testing methodologies.
The data provenance is from non-clinical testing conducted by Better Care Plastic Technology Co., Ltd. located in Hebei Province, China. The data is prospective in the sense that these tests were conducted specifically to support this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation of these medical gloves relies on objective measurements performed according to recognized international standards (ASTM, ISO). There is no "ground truth" derived from expert consensus on medical images or clinical outcomes for this type of device. The "truth" is established by the standardized test methods themselves and the resulting physical and chemical measurements.
4. Adjudication method for the test set
This information is not applicable. The tests performed are objective, quantitative measurements according to predefined standards. There is no subjective assessment requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This is a medical glove, a physical device, and not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. As mentioned above, this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of these gloves is based on objective measurements derived from standardized test methods (ASTM D6319-10, ASTM D6978-05, ISO 10993 series). For example:
- Physical properties (e.g., tensile strength, elongation): Measured directly by testing equipment following ASTM protocols.
- Freedom from holes: Determined by a standardized water-leak test (ASTM D5151-06).
- Chemotherapy drug permeation: Measured by detecting the breakthrough of chemotherapy drugs through the glove material over time, as per ASTM D6978-05.
- Biocompatibility: Evaluated using established in-vitro and in-vivo biological tests (cytotoxicity, irritation, sensitization) according to ISO 10993 standards.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of validating a medical glove. The product is manufactured and then tested to ensure it meets performance standards.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.
The following chemicals have been tested with these gloves.
The tested chemotherapy drugs' breakthrough detection times are listed as follows:
Chemotherapy Drug Minimum BDT
Carmustine, 3.3 mg/ml 16.0 min.
Cisplatin, 1.0 mg/ml >240 min.
Cyclophosphamide (Cytoxan) , 20 mg/ml >240 min.
Doxorubicin Hydrochloride, 2.0 mg/ml >240 min.
Etoposide (Toposar) , 20.0 mg/ml >240 min.
Fluorouracil, 50.0 mg/ml >240 min.
Methotrexate, 25 mg/ml >240 min.
Paclitaxel (Taxol) , 6.0 mg/ml >240 min.
Thiotepa, 10.0 mg/ml 16.6 min.
Vincristine Sulfate, 1.0 mg/ml >>240 min
Please note that the following drugs have extremely low permeation time of less than 30 minutes. Carmustine (3.3 mg/ml) has a minimum breakthrough time of 16.0 minutes; and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 16.6 minutes. WARNING: Do not use with Carmustine and Thio-Tepa.
The subject device is single-use disposable powder-free surgical glove that is supplied sterile and made of polyisoprene. The gloves have been tested for use with chemotherapy drugs per ASTM D6978.
The provided document describes the acceptance criteria and performance data for "Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use with Chemotherapy Drugs" (K171898) compared to a predicate device, "SensiCare PI Surgical Glove" (K152428).
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Predicate Device K152428 & ASTM Standards) | Reported Device Performance (Subject Device K171898) |
|---|---|---|
| Physical Properties | ||
| Dimensions - Length | Meets ASTM D3577: 270mm min. | Similar |
| Dimensions - Width | Meets ASTM D3577: 5 1/2-70±6mm, 6-76±6mm, 6 1/2-83±6mm, 7-89±6mm, 7 1/2-95±6mm, 8-102±6mm, 8 1/2-108±6mm, 9-114±6mm | Similar |
| Dimensions - Finger Thickness | Meets ASTM D3577: 0.10mm min. | Similar |
| Dimensions - Palm Thickness | Meets ASTM D3577: 0.10mm min. | Similar |
| Dimensions - Cuff Thickness | Meets ASTM D3577: 0.10mm min. | Similar |
| Before Aging - Tensile Strength | Meets ASTM D3577: 17 MPa min | Similar |
| Before Aging - Ultimate Elongation | Meets ASTM D3577: 650% min | Similar |
| Before Aging - Stress at 500% Elongation | Meets ASTM D3577: 7.0 MPa min | Similar |
| After Aging - Tensile Strength | Meets ASTM D3577: 12 MPa min | Similar |
| After Aging - Ultimate Elongation | Meets ASTM D3577: 490% min | Similar |
| Integrity | ||
| Freedom from holes | Meets 21 CFR 800.20 and ASTM D3577 when tested in accordance with ASTM D5151: Inspection Level 1, AQL 1.5 | Similar |
| Powder-Free - Residual Powder | 240 min | >240 min |
| Cyclophosphamide (Cytoxan), 20 mg/ml | >240 min | >240 min |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 min | >240 min |
| Etoposide (Toposar), 20.0 mg/ml | >240 min | >240 min |
| Fluorouracil, 50.0 mg/ml | >240 min | >240 min |
| Methotrexate, 25 mg/ml | >240 min | >240 min |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 min | >240 min |
| Thiotepa, 10.0 mg/ml | 11.6 min (predicate) | 16.6 min |
| Vincristine Sulfate, 1.0 mg/ml | >240 min | >240 min |
| Other Chemotherapy Drugs (e.g., Cytarabine, etc.)* | >240 min (for predicate, not explicitly tested for subject device in this summary) | Not explicitly stated for subject device in this summary (but overall conclusion states similarity) |
*Note: The subject device's comparison table explicitly lists only 10 chemotherapy drugs, while the predicate device listing includes an additional 5. However, the overall conclusion of substantial equivalence implies the subject device performs similarly across all relevant criteria that define the predicate. The document states a general conclusion that "The nonclinical testing performed... demonstrates that this device is as safe, as effective, and performs as well as the predicate device".
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the individual tests (e.g., number of gloves tested for physical properties, number of permeation tests for each chemotherapy drug).
- Test Set Sample Size: Not explicitly stated for each test.
- Data Provenance: The physical and chemical permeation testing would be conducted in a laboratory setting based on the specified ASTM and ISO standards. The manufacturer, Better Care Plastic Technology Co., Ltd., is located in China, suggesting the testing was likely conducted by or for them, potentially in China or a qualified testing facility. The data appears to be prospective as it was generated to demonstrate compliance for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to this type of device. The "ground truth" for surgical gloves and chemotherapy drug permeation is established through validated, standardized laboratory test methods (e.g., ASTM, ISO standards), not through expert consensus or clinical assessment in the same way an AI diagnostic imaging device would have. The "experts" in this context would be the technicians and scientists performing the tests according to the standard protocols.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints. For laboratory performance testing of physical properties and chemical resistance, the results are quantitative measurements against predefined criteria in the standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No. A MRMC comparative effectiveness study is not applicable to this type of medical device. This is a study design used for diagnostic devices, particularly in imaging, to assess reader performance with and without AI assistance. This document describes laboratory performance testing of a physical barrier device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No. This is not an algorithm or AI device. It's a physical medical device (surgical gloves). The performance tested relates to its physical and chemical barrier properties in a standalone manner (i.e., the glove itself, not with human interaction beyond wearing it).
7. The type of ground truth used:
The "ground truth" for this device's performance is established by objective measurements and validated test methods specified in international standards such as:
- ASTM D3577 (Standard Specification for Rubber Surgical Gloves)
- ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D6978 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
- ISO 10993 series (Biological evaluation of medical devices)
This is a form of objective laboratory data compliant with recognized standards.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set is relevant for this device.
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(76 days)
Better Care Plastic Technology Co.,Ltd.
This surgeon's glove is a sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
The subject device is single-use disposable powder-free surgical glove that is supplied sterile and made of polyisoprene.
The provided text is for a 510(k) premarket notification for Sterile Polyisoprene Powder Free Surgical Gloves and details the device's technical characteristics and substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the context of an AI/medical imaging device. Therefore, many of the requested categories for AI/medical imaging studies are not applicable.
However, I can extract the acceptance criteria and the device's reported performance from the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Technological Characteristics | Acceptance Criteria (Standard/Test/Guidance) | Reported Device Performance (Result Summary) |
|---|---|---|
| Dimensions | ASTM D3577-09(2015) requirements for length, width, and thickness | Meets ASTM D3577 requirements for length, width and thickness |
| - Length | Minimum 265mm | Average 305mm |
| - Palm Width (size 5½) | 70mm | 73mm |
| - Palm Width (size 6) | 76mm | 79mm |
| - Palm Width (size 6½) | 83mm | 86mm |
| - Palm Width (size 7) | 89mm | 91mm |
| - Palm Width (size 7½) | 95mm | 97mm |
| - Palm Width (size 8) | 102mm | 105mm |
| - Palm Width (size 8½) | 108mm | 111mm |
| - Palm Width (size 9) | 114mm | 117mm |
| - Thickness (Finger) | Minimum 0.10mm | 0.22mm |
| - Thickness (Palm) | Minimum 0.10mm | 0.20mm |
| - Thickness (Cuff) | Minimum 0.10mm | 0.18mm |
| Physical Properties | ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging | Meets ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging |
| - Tensile Strength, Before Aging | 17MPa, min | Average 19.4MPa |
| - Ultimate Elongation, Before Aging | 650%, min | Average 823% |
| - Stress at 500% Elongation | 7.0 MPa, max | Average 2.2MPa |
| - Tensile Strength, After Accelerated Aging | 12MPa, min | Average 17.1 MPa |
| - Ultimate Elongation, After Accelerated Aging | 490%, min | Average 748% |
| Freedom from holes | ASTM D3577-09(2015) and ASTM D5151-06(2015) requirements of AQL 1.5 | Meets ASTM D3577-09(2015) and ASTMD5151-06(2015) requirements of AQL 1.5 |
| Powder-Free | ASTM D3577-09(2015) and ASTM D6124-06(2011) - ≤ 2 mg per glove | Meets Applicable requirement for Powder Free; ≤ 2 mg per glove |
| Sterility | ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL | Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL |
| Biocompatibility (Skin Irritation) | ISO 10993-10:2010 | Under the conditions of the study, not an irritant |
| Biocompatibility (Maximization Sensitization) | ISO 10993-10:2010 | Under the conditions of the study, not a sensitizer |
Regarding the other requested information (primarily for AI/medical imaging studies):
- 2. Sample sized used for the test set and the data provenance: Not applicable. This document describes testing for physical and biological properties of surgical gloves, not an AI model. The tests refer to ASTM and ISO standards, which define the testing methodologies and sample sizes for those specific tests.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/medical imaging (e.g., expert consensus on image findings) is not relevant here. The "ground truth" for the glove's performance is adherence to established engineering and biocompatibility standards.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus methods for expert reviewers, which is not relevant for this type of device testing.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, the "ground truth" is defined by the objective performance specified in the referenced ASTM and ISO standards (e.g., a specific tensile strength value, freedom from holes at a certain AQL).
- 8. The sample size for the training set: Not applicable. This is not an AI device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI device.
Key takeaway from the document: The device demonstrates compliance with recognized national and international standards (ASTM and ISO) for surgical gloves. The "study" proving the device meets the acceptance criteria consists of various material, physical, and biological tests conducted according to these standards, with the results compared directly to the specified requirements within those standards. A clinical study was explicitly stated as not conducted for either the subject or predicate devices.
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