Search Results
Found 15 results
510(k) Data Aggregation
(204 days)
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential.
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)
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy
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
(219 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is non-sterile and disposable medical glove intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is made of nitrile butadiene rubber (NBR), as per standard meets ASTM D6319-10(Reapproved 2015).
The proposed device is Powder Free Nitrile Examination and variants of different sizes, such as size S/M/L/XL. All variants share the same color, blue.
The provided text describes the 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color" (K211864). This document primarily focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device. It specifically states that "Clinical testing is not needed for this device." Therefore, the requested information pertaining to AI/ML device studies, such as multi-reader multi-case studies, expert adjudication, training/test set ground truth establishment, or sample sizes for AI model development, is not applicable to this submission.
The document outlines the acceptance criteria and reported device performance based on non-clinical tests.
Here is the table summarizing the acceptance criteria and stated performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D 6319-06 (Reapproved 2015) | Dimension Length | ≥ 230mm | 237 mm min for all sizes | Pass |
| Dimension Width | Small 70-90 mm | 85-87 mm | Pass | |
| Medium 85-105mm | 95-97 mm | Pass | ||
| Large 100-120mm | 105-107mm | Pass | ||
| X large 110-130 mm (from comparison table) | 115-117 mm (from comparison table) | Pass | ||
| Thickness | Fingertip ≥ 0.05 mm | 0.091mm | Pass | |
| Palm ≥ 0.05 mm | 0.072mm | Pass | ||
| ASTM D 6319-06 (Reapproved 2015) | Physical Properties: Tensile strength (Before & After aging) | ≥14MPa | 16.5-19.3 MPa | Pass |
| Physical Properties: Before aging Elongation | ≥500% | 526-560% | Pass | |
| Physical Properties: After aging Elongation | ≥400% | 432-492% | Pass | |
| • 21 CFR 800.20, • ASTM D 6319-06 (Reapproved 2015), • ASTM D5151-19 | Freedom from pinholes: Water leakage test | Inspection Level I, AQL2.5, and Accept/Reject criteria of 10/11. | 2 noncompliance is allowed. | Pass |
| • ASTM D6319-10 (Reappr oved 2015), • ASTM D6124-06 (Reapproved 2017) | Powder Residual |
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(240 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
The provided text is a 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color," which is a Class I medical device. This type of device does not typically involve complex algorithms or AI; instead, its performance is evaluated based on physical characteristics and material biocompatibility against established standards. Therefore, the requested information regarding AI-specific evaluation criteria (like multi-reader multi-case studies, expert adjudication, AI effect size, training set details) is not applicable to this submission.
Here's a breakdown of the acceptance criteria and study information that is relevant and available in the document:
1. A table of acceptance criteria and the reported device performance
| Feature/Test | Acceptance Criteria (Predicate or Standard) | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| Dimensions - Length (ASTM D6319-10) | ≥230mm min | 232 mm min for all sizes | Similar |
| Dimensions - Width (ASTM D6319-10) | Small: 70-90mm | ||
| Medium: 85-105mm | |||
| Large: 100-120mm | |||
| X large: 110-130mm | Small: 76-90 mm | ||
| Medium: 87-102 mm | |||
| Large: 108-119mm | |||
| X large: 115-128 mm | Similar | ||
| Dimensions - Thickness (ASTM D6319-10) | Finger: 0.05mm min. | ||
| Palm: 0.05mm min. | Fingertip: ≥0.08mm | ||
| Palm: ≥0.08mm | Similar | ||
| Physical Properties - Tensile Strength (Before & After aging) (ASTM D6319-10) | ≥ 14MPa | Before Aging: 18-25 MPa | |
| After Aging: 17-22 MPa | Similar | ||
| Physical Properties - Elongation (Before aging) (ASTM D6319-10) | ≥500% | Before Aging: 550-610% | Similar |
| Physical Properties - Elongation (After aging) (ASTM D6319-10) | ≥400% | After Aging: 450-570% | Similar |
| Freedom from Pinholes (21 CFR 800.20, ASTM D6319-10) | Inspection Level I AQL2.5; Accept/Reject criteria of 10/11 (Predicate) | Water leakage test: 5 noncompliance is allowed. | Similar |
| Residual Powder (ASTM D6124-06) | Below 2mg of residual powder | Mean: 0.1mg/pcs | Pass |
| Biocompatibility - Primary Skin Irritation (ISO 10993-10:2010) | Non-irritant | Under the conditions of the study, the subject device is not a primary skin irritant. | Passes |
| Biocompatibility - Dermal Sensitization (ISO 10993-10:2010) | Non-sensitizer | Under the conditions of the study, the subject device is not a skin sensitizer. | Passes |
| Biocompatibility - Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxicity to L-929 cells | Under the conditions of this study, the test article was non-cytotoxicity to L-929 cells. | Pass |
| Biocompatibility - Acute Systemic Toxicity (ISO 10993-11:2017) | No systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern. | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each physical test. However, it indicates general inspection levels where applicable, such as "ILS-2 AQL4.0" for dimensions and "Inspection Level I AQL2.5" for freedom from pinholes. For residual powder, it states "Checked on 5pcs sub-samples (N=5)."
The provenance of the data is from non-clinical laboratory testing performed by the manufacturer to demonstrate compliance with relevant ASTM and ISO standards. The document does not specify the country of origin of the raw data, but the manufacturer is Shandong Shangwei Medical Products Co.,Ltd, located in China. The studies are prospective in nature, as they are specifically conducted to test the performance of the device against predefined criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device is based on objective measurements against established international and national standards (ASTM, ISO, CFR) for physical properties and biocompatibility. It does not involve expert interpretation or subjective assessment of medical images or patient conditions.
4. Adjudication method for the test set
Not applicable. As described above, this is not an AI or diagnostic device requiring expert adjudication. Test results are quantitative measurements compared against predefined thresholds in standards.
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 device is a patient examination glove and does not involve AI or human "readers" in a diagnostic capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm for this device.
7. The type of ground truth used
The ground truth used for this device's evaluation is based on established industry standards and objective laboratory measurements. These include:
- ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) for dimensions and physical properties.
- 21 CFR 800.20 and ASTM D5151-19 for freedom from pinholes.
- ASTM D6124-06 for residual powder.
- ISO 10993-5, ISO 10993-10, and ISO 10993-11 for biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity).
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore does not have a "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.
Ask a specific question about this device
(232 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Patient Examination Gloves. It details the device's characteristics and compares them to a predicate device to establish substantial equivalence.
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The device's performance is compared against established standards, primarily ASTM D6319-10 (Reapproved 2015) for Nitrile Examination Gloves for Medical Application, along with other ISO and ASTM standards for biocompatibility and specific tests.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D 6319-06 (Reapproved 2015) | Dimension | ||
| - Length | ≥230mm min | 232 mm min for all sizes (Similar to predicate) | |
| - Width | Small: 70-90 mm | ||
| Medium: 85-105mm | |||
| Large: 100-120mm | |||
| X large: 110-130 mm | Small: 75-90 mm | ||
| Medium: 88-102 mm | |||
| Large: 107-117mm | |||
| X large: 114-128 mm (Similar to predicate) | |||
| - Thickness | Fingertip: ≥0.05mm min. | ||
| Palm: ≥0.05mm min. | Fingertip: ≥0.08mm | ||
| Palm: ≥0.08mm (Similar to predicate) | |||
| ASTM D 6319-06 (Reapproved 2015) | Physical Properties | ||
| - Tensile strength (Before & After aging) | ≥ 14MPa | 17-24 (Before Aging), 17-22 (After Aging) (Similar to predicate) | |
| - Before aging Elongation | ≥500% | 540-610 (Similar to predicate) | |
| - After aging Elongation | ≥400% | 460-570 (Similar to predicate) | |
| 21 CFR 800.20 | |||
| ASTM D 6319-06 (Reapproved 2015) | |||
| ASTM D5151-19 | Freedom from pinholes | Water leakage test: Inspection Level I, AQL 2.5, and Accept/Reject criteria of 10/11. | 5 noncompliance is allowed (Similar to predicate) |
| ASTM D6319-10 (Reapproved 2015) | |||
| ASTM D6124-06 (Reapproved 2017) | Powder Residual |
Ask a specific question about this device
(58 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
This document is a 510(k) Premarket Notification summary for Powder Free Nitrile Patient Examination Gloves, Blue Color. It does not describe an AI medical device or a study involving human readers. Therefore, I cannot provide details on acceptance criteria or an AI-related study as described in your request.
The provided text details the submission of a medical device (nitrile examination gloves) for regulatory clearance. The core of the submission, and the content of the "Acceptance Criteria" table, relates to physical and chemical properties of the gloves, and biocompatibility, as tested against established ASTM and ISO standards.
Here's an analysis of the existing content in relation to your request, highlighting what's present and what's missing:
1. A table of acceptance criteria and the reported device performance
The provided text contains a comprehensive table on page 4 titled "Features & Description" which functions as the acceptance criteria and reported device performance.
| Features & Description | Acceptance Criteria (from Subject Device) | Reported Performance (from Subject Device) |
|---|---|---|
| Dimension - Length | ≥230mm min (from predicate guidance) | 232 mm min for all sizes |
| Dimension - Width | Small 75-90 mm, Medium 87-102 mm, Large 107-119mm, X large 114-128 mm | Measured values for each size fall within these ranges (implied by "Similar" and comparison to predicate values) |
| Dimension - Thickness | Fingertip ≥0.08mm min, Palm ≥0.08mm min | Fingertip 0.08mm min, Palm 0.08mm min (reported as "Similar" to predicate which implies meeting criteria) |
| Physical Properties - Tensile strength (Before & After aging) | ≥14MPa | Before Aging: 19-25 MPa; After Aging: 17-23 MPa |
| Physical Properties - Elongation (Before aging) | ≥500% | 560-610 % |
| Physical Properties - Elongation (After aging) | ≥400% | 460-570 % |
| Freedom from Pinholes (Water leakage test) | Inspection Level I, AQL2.5, Accept/Reject criteria of 10/11. 5 noncompliance is allowed. | Meets criteria (implied by "Similar" and no reported failure) |
| Residual Powder |
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(265 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
The provided text is a 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color," a Class I medical device. This document is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate substantial equivalence to a predicate device already on the market.
It's important to understand that a 510(k) submission for a Class I device like examination gloves does not involve the kind of "AI-driven medical device" performance evaluation that the prompt is asking for (e.g., acceptance criteria for AI model performance, human reader improvement studies, ground truth establishment for complex image analysis).
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to physical and biological performance standards for gloves, not the performance of an AI algorithm. Therefore, I cannot fulfill most of the prompt's requests because they are not applicable to the device described in the document.
Here's how the provided information relates to the prompt, and why most points cannot be answered based on this document:
1. A table of acceptance criteria and the reported device performance
The document provides a "Technological Characteristic Comparison Table" (Section 6.0) that lists various physical and chemical properties of the gloves and compares them to the predicate device. These are the "acceptance criteria" for this type of device.
| Features & Description | Acceptance Criteria (Predicate Device K120970, based on ASTM D6319-10/21 CFR 800.20/ASTM D6124-06) | Reported Device Performance (Subject Device K181106) |
|---|---|---|
| Product name | Powder Free Nitrile Patient Examination Glove, Blue Color | Powder Free Nitrile Patient Examination Gloves, Blue Color |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 |
| Product Code | LZA | LZA |
| Color | Blue | Blue |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large |
| Indications for Use | Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. |
| Device Description & Specs | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Dimensions -- Length (ILS-2 AQL4.0) | Meets ASTM D6319-10; ≥230mm min. | 232 mm min for all sizes |
| Dimensions -- Width (ILS-2 AQL4.0) | Meets ASTM D6319-10; Small 70-90 mm, Medium 85-105mm, Large 100-120mm, X large 110-130 mm | Small 76-90 mm, Medium 89-102 mm, Large 108-119mm, X large 115-128 mm |
| Dimensions -- Thickness (ILS-2 AQL4.0) | Meets ASTM D6319-10; Finger 0.05mm min., Palm 0.05mm min. | Finger 0.08 mm min., Palm 0.08 mm min. |
| Physical Properties (Before Aging) | Tensile Strength ≥14MPa, Elongation ≥500% | Tensile Strength: 18-25 MPa, Elongation: 550-600% |
| Physical Properties (After Aging) | Tensile Strength ≥14MPa, Elongation ≥400% | Tensile Strength: 17-22 MPa, Elongation: 450-570% |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D6319-10; Inspection Level I AQL2.5, Accept/Reject criteria of 10/11; Water leakage test: 5 noncompliance allowed. (Predicate) | 1) Inspection Level I AQL2.5, and Accept/Reject criteria of 10/11; 2) Water leakage test: 5 noncompliance is allowed. (Subject) |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011); below 2mg of residual powder | Checked on 5pcs sub-samples (N=5). Mean: 0.1mg/pcs |
| Materials used to fabricate | Nitrile | Nitrile |
| Single Patient Use | Single Patient Use | Single Patient Use |
| Biocompatibility | Non-irritant or non-sensitizer (Predicate) | Non-irritant or non-sensitizer; non-cytotoxicity to L-929 cells (Subject) |
| Labeling | -Powder Free, -Patient Examination Glove, -Single Use Only, -Manufactured For:, -Lot, -Blue color | -Powder Free, -Patient Examination Glove, -Single Use Only, -Manufactured For:, -Lot, -Blue color |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions a specific sample size for "Residual Powder" (5 sub-samples) and implies inspection levels for Length, Width, Thickness, and Pinholes (e.g., ILS-2 AQL 4.0, Inspection Level I AQL 2.5). These refer to standardized statistical sampling plans for quality control in manufacturing, not a clinical "test set" for an algorithm.
- Data Provenance: The tests are "non-clinical tests" conducted to verify the device meets acceptance criteria. The manufacturer is JiangSu DongXin Medical Technology Co., Ltd in China. The "data provenance" would be in-house laboratory testing based on specified ASTM and ISO standards. These are prospective quality control tests for manufacturing, not retrospective/prospective clinical data collection.
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. "Ground truth" in this context refers to the measured physical and chemical properties of the gloves conforming to established standards, not expert interpretations of images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is for assessing inter-reader variability in clinical image interpretation, not for glove 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 device is a physical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. No algorithm is involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is adherence to established international standards (ASTM D6319-10 for examination gloves, ISO 10993 for biocompatibility, etc.) and direct physical/chemical measurements (e.g., tensile strength, elongation, dimensions, residual powder weight, water leakage). It's based on quantitative and qualitative measurements against predefined physical and biological acceptance criteria outlined in consensus standards.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set.
In summary, the provided document details the regulatory clearance of medical examination gloves, which are tested against physical and biocompatibility standards, not AI performance metrics.
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(49 days)
Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color
Xing Yu Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile films form a barrier to prevent contamination between patient and examiner. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151.
The provided document is a 510(k) Premarket Notification for a medical device (Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's clinical performance against detailed acceptance criteria in the context of, for example, an AI/ML diagnostic device.
Therefore, the specific information requested in your prompt regarding acceptance criteria and a study to prove the device meets them (especially points 2-9, which relate to diagnostic performance studies) is not applicable in the context of this document.
However, I can extract information related to the performance specifications used to demonstrate substantial equivalence of the gloves, which are akin to acceptance criteria based on established standards for medical examination gloves.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
The device's performance is measured against ASTM standards and FDA regulations for examination gloves. The "acceptance criteria" here are the requirements of these standards. The "reported device performance" indicates whether the device met these criteria.
| Characteristics | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension (Length) | ASTM D6319-10 (reapproved 2015): $\geq$ 230mm | $\geq$ 232mm (for all sizes) |
| Dimension (Width) | ASTM D6319-10 (reapproved 2015): Small 70-90mm, Medium 85-105mm, Large 100-120mm, XLarge 110-130mm | Small 76-88mm, Medium 89-102mm, Large 108-119mm, XLarge 115-128mm |
| Thickness (Fingertip) | ASTM D6319-10 (reapproved 2015): $\geq$ 0.05mm | $\geq$ 0.08mm |
| Thickness (Palm) | ASTM D6319-10 (reapproved 2015): $\geq$ 0.05mm | $\geq$ 0.08mm |
| Physical Properties (Tensile Strength Before Aging) | ASTM D6319-10 (reapproved 2015): $\geq$ 14MPa | 18-25MPa |
| Physical Properties (Tensile Strength After Aging) | ASTM D6319-10 (reapproved 2015): $\geq$ 14MPa | 17-22MPa |
| Physical Properties (Elongation Rate Before Aging) | ASTM D6319-10 (reapproved 2015): $\geq$ 500% | 530-600% |
| Physical Properties (Elongation Rate After Aging) | ASTM D6319-10 (reapproved 2015): $\geq$ 400% | 460-580% |
| Freedom from Pinholes | 21 CFR 800.20, ASTM D6319-10 (reapproved 2015) - Test method: ASTM D5151-06 (reapproved 2015) | Passed Standard Acceptance Criteria (Tested with acceptable results) |
| Powder Residual | ASTM D6319-10 (reapproved 2015) - Test method: D6124-06 (reaffirmation 2011): Meets 0.1mg/glove (equivalent to below 2mg of residual powder implied by predicate comparison) | Meets 0.1mg/glove (Results generated values below 2mg of residual powder) |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10: Third Edition 2010-08-01 (Not a primary skin irritant) | Passes (Not a primary skin irritant) |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10: Third Edition 2010-08-01 (Not a skin sensitizer) | Passes (Not a skin sensitizer) |
Non-Applicable Information for this Document:
The following points are typically relevant for diagnostic devices, especially those incorporating AI/ML. This 510(k) for examination gloves does not contain this type of information.
- Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing of physical properties and biocompatibility, not a test set of data for diagnostic performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic classifications is not established for this device.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not a diagnostic device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (gloves), not an algorithm.
- The type of ground truth used: Not applicable. The "ground truth" for gloves is adherence to material, physical, and biocompatibility standards.
- The sample size for the training set: Not applicable. There is no AI/ML training set for this device.
- How the ground truth for the training set was established: Not applicable.
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(154 days)
Powder Free Nitrile Patient Examination Gloves, Blue
The powder free nitrile patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device, Powder Free Nitrile Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Patient Examination Gloves, and includes variations of different size and color. The colors of proposed device is Blue.
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
The provided text describes the acceptance criteria and the study results for the Powder Free Nitrile Patient Examination Gloves, Blue. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are established by various ASTM and ISO standards. The reported device performance generally indicates compliance with these standards.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| Physical Properties Before Aging (ASTM D6319) | |
| - Tensile Strength | 15 MPa |
| - Ultimate Elongation | 500 % min |
| Physical Properties After Aging (ASTM D6319) | |
| - Tensile Strength | 14 MPa |
| - Ultimate Elongation | 400 % min |
| Freedom from Holes (ASTM D5151) | Free from holes when tested in accordance with ASTM D5151 |
| Powder Content (ASTM D6124) | Max. 0.32 mg per glove |
| Biocompatibility (ISO 10993-10) | |
| - Irritation | Under the conditions of the study, not an irritant |
| - Sensitization | Under conditions of the study, not a sensitizer |
| Device Dimensions (ASTM D6319) | |
| - Length, mm (XS, S, M, L, XL) | min (specific values for XS-XL not provided for proposed, but for predicate) |
| - Width, mm (XS, S, M, L, XL) | 70, 80, 95, 110, 120 (± 10) |
| - Thickness, mm: Finger | 0.10 (± 0.03) |
| - Thickness, mm: Palm | 0.08 (± 0.03) |
| - Thickness, mm: Cuff | 0.06 (± 0.03) |
| Sampling Procedures for Inspection by Attributes (ISO 2859-1:1999) | Complies with standard |
2. Sample Size Used for the Test Set and the Data Provenance:
The document broadly states that "Bench tests were conducted to verify that the proposed device met all design specifications as compared to the predicate device."
- Sample Size: The exact sample size for each test is not specified in the provided document. The ISO 2859-1:1999 standard is cited for "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection," implying that sampling was done according to this standard, but the specific AQL levels or sample sizes used are not detailed.
- Data Provenance: The document implies the data is prospective as it describes tests conducted to verify the proposed device. The manufacturer is "HEBEI TITANS MEDICAL SUPPLY TECHNOLOGY GROUP CO., LTD." in China, suggesting the tests were conducted in or overseen by this Chinese entity.
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 (patient examination gloves). The "ground truth" for glove performance is established through objective physical, mechanical, and biological testing against recognized standards, not through expert human interpretation of results in the way an AI medical imaging device would require.
4. Adjudication Method for the Test Set:
This is not applicable to this type of device. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in expert-based assessments (e.g., medical image interpretation), which is not relevant here. The tests conducted are objective measurements against established standards.
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 is relevant for AI-assisted diagnostic devices where human readers interpret medical images or data. The device in question is a physical medical glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is not applicable. "Standalone performance" refers to the performance of an algorithm or AI without human input in a diagnostic or interpretive context. The device is a physical glove, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for proving the device meets acceptance criteria is based on objective measurement against established industry standards, specifically:
- ASTM Standards: ASTM D6319-10 (physical properties), ASTM D5151-06 (freedom from holes), ASTM D6124-06 (residual powder).
- ISO Standards: ISO 2859-1:1999 (sampling procedures), ISO 10993-10:2010 (biocompatibility: irritation and skin sensitization).
- Performance Metrics: Quantifiable measurements such as tensile strength (MPa), ultimate elongation (%), powder content (mg/glove), dimensions (mm), and qualitative assessments (e.g., "not an irritant," "free from holes").
8. The Sample Size for the Training Set:
This is not applicable as there is no "training set" in the context of physical medical devices like gloves. Training sets are used for machine learning models.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no training set.
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(235 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
The provided document describes the acceptance criteria and the study results for the "Powder Free Nitrile Patient Examination Gloves, Blue Color" (subject device) which is seeking substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Characteristics | Standard (Acceptance Criteria) | Device Performance (Subject Device) |
|---|---|---|
| Dimension | ASTM standard D 6319-10. | |
| Length | ≥230mm | 234-243mm |
| Width (Small) | 70-90 mm | 78-85mm |
| Width (Medium) | 85-105mm | 95-99mm |
| Width (Large) | 100-120mm | 108-113mm |
| Width (X large) | 110-130 mm | 117-126mm |
| Thickness (Fingertip) | ≥0.05mm | 0.08-0.11 mm |
| Thickness (Palm) | ≥0.05mm | 0.08-0.12 mm |
| Physical Properties | ASTM standard D 6319-10. | |
| Tensile strength (Before aging) | ≥14MPa (based on predicate comparison) | 20-23MPa |
| Tensile strength (After aging) | ≥14MPa | 18-21 MPa |
| Elongated rate (Before aging) | ≥500% | 560-600% |
| Elongated rate (After aging) | ≥400% | 530-580% |
| Freedom from pinholes | • 21 CFR 800.20 | |
| • ASTM standard D 6319-10. | ||
| • Test method in accordance with ASTM D5151-06(Reapproved 2011) | Passed Standard Acceptance Criteria (Tested in accordance with ASTM D5151 (Reapproved 2011) with acceptable results) | |
| Powder Residual | ASTM standard D 6319-10. | |
| Test method in accordance with D6124-06 (Reaffirmation 2011) | ||
| below 2mg of residual powder (based on predicate comparison) | 0.1mg/glove (Results generated values below 2mg of residual powder) | |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10: Third Edition 2010-08-01) | Under the conditions of the study, the device was a non-irritant. |
| Dermal sensitization in the guinea pig (ISO 10993-10: Third Edition 2010-08-01) | Under the conditions of the study, the device was a non-sensitizer. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for dimensions, tensile strength, pinholes). However, it implies testing was conducted on samples derived from the "Powder Free Nitrile Patient Examination Gloves, Blue Color."
The data provenance is from China, as the submitter, Suqian Xingye Glove Co,Ltd, is located in Suqian City, Jiangsu Province, China. The studies appear to be prospective as they were conducted to obtain data for 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 is not applicable to this submission. The "ground truth" for glove performance is established by standardized testing methods (ASTM, CFR, ISO) rather than expert consensus on medical images or diagnoses.
4. Adjudication method for the test set:
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., diagnostic image reading) where there might be disagreement among experts. For performance testing of medical gloves, the results are determined by objective measurements against established standards.
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. MRMC studies are relevant for AI-powered diagnostic tools or decision support systems. This submission concerns the physical and biological properties of patient examination gloves, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. There is no AI algorithm involved in the performance of patient examination gloves. The device's performance is standalone in the sense that its physical properties are measured directly.
7. The type of ground truth used:
The ground truth used for these studies are:
- Standardized specifications: Primarily ASTM standards (e.g., D6319-10, D5151-06, D6124-06) and FDA regulations (21 CFR 800.20) for physical properties.
- Biological safety standards: ISO 10993-10: Third Edition 2010-08-01 for biocompatibility.
- These standards define the acceptable range or threshold for each characteristic (e.g., minimum length, maximum powder residual, non-irritant/non-sensitizer).
8. The sample size for the training set:
This is not applicable. "Training set" refers to data used to train machine learning models. This submission is for a physical medical device (gloves) and does not involve AI or machine learning.
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for a machine learning model.
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