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510(k) Data Aggregation
(28 days)
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
The Powder Free Nitrile Examination Gloves (Blue) , Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. The tested chemotherapy drugs are: Carmustine 3.3 mg/ml(3,300 ppm) 27.7 (35.5,27.7,27.7) Cisplatin 1 mg/ml (1,000 ppm) >240min Cyclophosphamide 20 mg/ml (20,000 ppm) >240min Dacarbazine 10mg/ml (10,000 ppm) >240min Doxorubicin HCl 2 mg/ml(2,000 ppm) >240min Etoposide 20 mg/ml (20,000 ppm) >240min Fluorouracil 50mg/ml(50,000 ppm) >240min Gemcitabine HCl 38 mg/ml (38,000 ppm) >240min Ifosfamide 50mg/ml (50,000 ppm) >240min Methotrexate 25mg/ml (25,000 ppm) >240min Mitomycin C 0.5 mg/ml(500 ppm) >240min Mitoxantrone HC1 2 mg/ml (2,000 ppm) >240min Paclitaxel 6 mg/ml (6,000 ppm) >240min Thiotepa 10 mg/ml (10,000 ppm) 59.4(67.5,59.4,65.9) Vincristine Sulfate 1 mg/ml (1,000 ppm) > 240min The tested non-chemotherapy drugs are: Fentanyl Citrate injection 100mcg/2ml >240min Note: Carmustine and Thiotepa have extremely low permeation times of 27.7 and 59.4 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa
The Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are blue color, powder free, nitrile gloves. The gloves are offered in six sizes: XS、S、M、L、XL、XXL, packed in a paper box.
The proposed gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978-05. The proposed device was modification from the legally marketed (existing) device "Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)"/K202356, manufactured by "KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED", same as the sponsor of this submission.
There are two modifications, one is to add a large model XXL, and the other is to add the "Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" indications for use than the legally marketed (existing) device. Testing has been conducted on the proposed device passed as per ASTM D6978-05, ASTM D6319-19, ASTM D5151-19, ASTMD 6124-06.
The materials and the manufacturing process technology are the same.
The provided document (a 510(k) summary for medical gloves) does not contain information about a study that proves a device meets acceptance criteria related to AI/ML or human reader performance. The document is for "Powder Free Nitrile Examination Gloves" and pertains to mechanical and material properties, as well as resistance to chemical permeation.
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for a test set or data provenance for an AI/ML device.
- Number of experts used to establish ground truth or their qualifications for an AI/ML device.
- Adjudication method for an AI/ML device test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study for human readers with and without AI.
- Standalone performance of an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
- Sample size for the training set of an AI/ML device.
- How the ground truth for an AI/ML training set was established.
However, based on the document, I can present the acceptance criteria and performance for the glove device as non-clinical testing.
Acceptance Criteria and Study for Powder Free Nitrile Examination Gloves
This document describes the non-clinical testing performed on "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing of Gloves):
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Test | Length (mm): XS/S/M/L/XL/XXL: ≥230 | Pass |
| Width (mm): XS: 70±10mm; S: 85±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass | ||
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Pass | ||
| ASTM D5151-19 | Watertightness Test for Detection of Holes | Be free from holes when tested in accordance with ASTM D5151 | Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: 14MPa, min | Pass |
| Ultimate Elongation: 500% min | Pass | ||
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: 14MPa, min | Pass |
| Ultimate Elongation: 400% min | Pass | ||
| ASTM D6124 | Powder Content | Meet the requirements of Less than 2mg per glove | Pass |
| ASTM D6978-05 (2019) | Detect the Permeation time by Chemotherapy Drugs and Fentanyl of the glove | Meet the requirements of ASTM D6978-05. (Specific breakthrough times listed elsewhere in document) | Pass |
| ISO 10993-10 | Irritation and Sensitization | Non-irritating; Non-sensitizer | Under the conditions of the study, not an irritant and not a sensitizer |
| ISO 10993-5 | Cytotoxicity | Non Cytotoxic | Under conditions of the study, not cytotoxic |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (e.g., number of gloves tested for each attribute) for the physical and chemical resistance tests. It only states that tests were conducted according to the listed ASTM and ISO standards.
- Data Provenance: The testing was conducted to verify that the device meets design specifications and complies with international standards. The origin of the testing data is not explicitly stated beyond being "non-clinical tests."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the device is a medical glove, not an AI/ML diagnostic or prognostic tool. Ground truth is established by objective physical and chemical measurements following established standards, not by expert consensus or physician reads.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable 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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used:
- For the physical properties (dimensions, watertightness, tensile strength, powder content), the ground truth is based on direct physical measurement and standard test methods outlined in ASTM standards.
- For chemical permeation (chemotherapy drugs and Fentanyl), the ground truth is established by analytical measurement of breakthrough time according to ASTM D6978-05.
- For biocompatibility (irritation, sensitization, cytotoxicity), the ground truth is established by biological assays according to ISO 10993 standards.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device. The "training" for glove manufacturing relates to process control and material specifications, not a data-driven model.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
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(52 days)
Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate
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, Fentanyl Citrate, and select other drugs using ASTM D6978-05(2019)
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs 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, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and non-sterile.
The provided document describes the acceptance criteria and performance of "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs" (K240051).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions | ||
| Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL, XXL (ASTM D6319-19) | Pass |
| Palm Width (size) | XS: 70±10 mm, S: 80±10 mm, M: 95±10 mm, L: 110±10 mm, XL: 120±10 mm, XXL: 130±10 mm (ASTM D6319-19) | Pass |
| Thickness | Finger: 0.05mm (min), Palm: 0.05mm (min) (ASTM D6319-19) | Pass |
| Physical Properties | ||
| Tensile Strength & Elongation (Before Aging) | Tensile Strength: 14MPa, min; Elongation: 500%, min (ASTM D6319-19, ASTM D412-16(2021)) | Pass |
| Tensile Strength & Elongation (After Accelerated Aging) | Tensile Strength: 14MPa, min; Elongation: 400%, min (ASTM D6319-19, ASTM D412-16(2021)) | Pass |
| Barrier Integrity | ||
| Watertight (1000ml) | G-I, AQL 2.5 (21 CFR 800.20, ASTM D5151-19) | Pass |
| Powder Residue | Max 2mg/glove (ASTM D6319-19, ASTM D6124-06(2017)) | Pass |
| Chemotherapy Drugs & Opioid Drug Permeation | Minimum Breakthrough Detection Time (BDT) for various chemotherapy drugs and Fentanyl Citrate. Accepted values differ by drug, but generally, longer BDT indicates better performance. Specific acceptance criteria are not explicitly listed as a single value but are implied by the reported BDTs (e.g., >240 minutes for many drugs, with lower specific values for Carmustine and Thiotepa which are cautioned against). | See specific BDT values in the tables below for each drug. Notably, Carmustine: 29.1 minutes, Thiotepa: 78.3 minutes. All other listed drugs exhibit >240 minutes BDT. Fentanyl Citrate: >240 minutes. |
| Biocompatibility | ||
| Irritation and Skin Sensitization | Non-sensitization and Non-irritation (ISO 10993-10 & -23) | Non-sensitization and Non-irritation |
| Cytotoxicity | Cytotoxicity reactivity (ISO 10993-5:2009) | Showed potential toxicity to L929 cells, but concern addressed by acute systemic toxicity testing. |
| Acute systemic toxicity study | No adverse biological reaction (ISO 10993-11:2017) | No evidence of acute systemic toxicity. |
Chemotherapy, Fentanyl Citrate & other drugs Permeation Comparison (Proposed Device K240051):
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine 3.3 mg/ml (3,300 ppm) | 29.1 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine, 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 Phosphate, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine HCL, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan HCL, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan HCL, 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 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 78.3 |
| Topotecan HCL, 1mg/ml (1,000ppm) | >240 |
| Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
Warning: Do not use with Carmustine and Thiotepa due to "extremely low permeation times" (29.1 minutes and 78.3 minutes, respectively).
2. Sample size used for the test set and the data provenance:
- The document primarily refers to standard ASTM and ISO test methodologies for device performance (e.g., ASTM D6319-19, ASTM D6978-05(2019), ISO 10993 series). These standards typically define the sample sizes required for each specific test to ensure statistical validity.
- Data Provenance: The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The tests were performed by Lingshi Hongruida Health Protection Technology Co., Ltd. located in China. The data is retrospective in the sense that the testing was performed and then submitted with the 510(k) application. Specific details on exact sample sizes (e.g., number of gloves tested for each characteristic) within each standard are not explicitly detailed in this summary for every test. However, the chemotherapy drug permeation testing likely involved multiple samples per drug as per ASTM D6978.
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 device is a physical medical device (examination glove) and the testing involved objective, quantitative, and standardized measurements according to established consensus standards (ASTM, ISO). There were no "experts" establishing a "ground truth" in the way they would for, say, image interpretation or clinical diagnosis. The ground truth for performance relied on the specified chemical and physical property measurements.
4. Adjudication method for the test set:
- This is not applicable. As mentioned above, the testing involved objective physical and chemical measurements governed by established standards, not subjective interpretations 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 is not applicable. This device is an examination glove, not an AI-powered diagnostic tool or imaging software. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is an examination glove and does not involve any algorithm or AI for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance is based on objective measurements against established performance standards and chemical permeation resistance thresholds.
- For physical properties (length, thickness, tensile strength, elongation, watertightness, powder content): The ground truth is the quantitative measurement compared against the specified ASTM standard values.
- For chemical permeation (chemotherapy drugs, Fentanyl Citrate): The ground truth is the experimentally determined Minimum Breakthrough Detection Time (BDT) in minutes, measured according to ASTM D6978-05(2019).
- For biocompatibility (irritation, sensitization, cytotoxicity, acute systemic toxicity): The ground truth is the experimental findings and conclusions derived from tests conducted under ISO 10993 series standards.
8. The sample size for the training set:
- This is not applicable. This device is a physical product, not a machine learning model, so there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of device.
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(30 days)
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl
The glove is disposable device intended for medical purpose 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 and fentanyl citrate in accordance with ASTM D6978.
The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs and fentanyl citrate claims. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and sterile. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for permeability to chemotherapy drugs and fentanyl citrate per ASTM D6978-05(2019).
The document provided is a 510(k) Premarket Notification from the FDA for "Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically by adding a claim for fentanyl citrate permeation. It performs non-clinical testing to support this claim, rather than a study involving AI or human readers for diagnostic purposes.
Therefore, many of the requested details regarding AI device acceptance criteria, human reader studies, and AI-specific ground truth establishment are not applicable to this submission. This is a clearance for a physical medical device (gloves), not a diagnostic AI/ML device.
However, I can extract the relevant information regarding the device's acceptance criteria and the non-clinical study conducted to prove it meets those criteria.
Acceptance Criteria and Study for Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
This medical device is a physical product (examination gloves), not an AI/ML diagnostic tool. The "acceptance criteria" here refer to the physical and chemical performance standards for the gloves, and the "study" refers to non-clinical bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the re-submitted device (K232039) are based on relevant ASTM and ISO standards, and for chemotherapy and opioid drug permeation, specific minimum breakthrough times (BDT). The reported device performance indicates that the gloves passed all these criteria.
| Referenced Standards / Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions (ASTM D6319-19) | Passed | |
| Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL | Pass (All size ≥290mm reported in 510(k) Summary, page 5) |
| Palm Width | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass (Reported ranges: XS: 76-78mm; S: 86-88 mm; M: 96-98mm; L: 106-108 mm; XL: 116-118 mm; XXL: 126-128 mm) |
| Thickness (Finger & Palm) | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass (Reported ranges: Palm: 0.09-0.11mm; Finger: 0.13-0.14mm) |
| Physical Properties (ASTM D6319-19, ASTM D412-16 (2021)) | Passed | |
| Tensile Strength (Before Aging) | Min 14 MPa | Pass (Reported range: 15.8-20.8 MPa) |
| Tensile Strength (After Accelerated Aging) | Min 14 MPa | Pass (Reported range: 15.6-19.8 MPa) |
| Ultimate Elongation (Before Aging) | Min 500% | Pass (Reported range: 500-560%) |
| Ultimate Elongation (After Accelerated Aging) | Min 400% | Pass (Reported range: 400-500%) |
| Freedom from holes (ASTM D6319-19, ASTM D5151-19) | G-I, AQL 2.5 | Pass (Meet AQL2.5 requirements) |
| Powder Residue (ASTM D6319-19, ASTM D6124-06 (2017)) | Max 2 mg/glove | Pass (≤ 2 mg, meet requirements) |
| Chemical Permeation (ASTM D6978-05 (2019)) | Passed (Refer to specific drug breakdown for values) | |
| Chemotherapy Drugs | See "Indications for Use" table on pages 3 and 6, and "Chemotherapy Permeation Comparison Claim" table on pages 7-8 for specific minimum BDTs for 15 listed drugs. | All reported BDTs met or exceeded the minimum requirements. For example, Carmustine (BCNU) had a BDT of 54.3 min (meeting criteria), and many others had >240 min. |
| Opioid Drug (Fentanyl Citrate Injection) | Minimum BDT >240 minutes | >240 minutes |
| Biocompatibility (ISO 10993-10:2010) | No Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| Biocompatibility (ISO 10993-11:2017) | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes used for each physical or chemical test. However, for tests like "Freedom from holes," it refers to AQL (Acceptable Quality Level) 2.5, which implies a sampling plan according to ASTM D5151-19. Similarly, other ASTM and ISO standards followed for physical properties and biocompatibility would specify sample sizes.
The data for these tests would be generated prospectively as part of product development and quality control for the submission. The country of origin for the data generation is implied to be China, given the manufacturer's location.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This concept is not applicable here. Ground truth in the context of this submission refers to the established standards and methodologies of the ASTM and ISO tests (e.g., how to measure tensile strength, how to test for permeation). These are standardized laboratory tests, not subjective expert interpretations of images or clinical outcomes. The "experts" are the laboratory personnel who perform these tests according to the published standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests have predefined, objective measurement protocols.
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 a physical medical device (gloves), not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in this device. Performance is measured directly through bench testing.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective, standardized laboratory measurements against predefined performance specifications stated in ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. Specifically:
- Physical Properties: Measured values (e.g., length, width, thickness, tensile strength, elongation) are compared directly against minimum/maximum thresholds defined in ASTM D6319-19 and ASTM D412-16.
- Freedom from holes: Determined by water leak testing according to ASTM D5151-19, with acceptance based on AQL 2.5.
- Powder Residue: Quantified according to ASTM D6124-06 (2017) against a maximum limit.
- Chemical Permeation: Breakthrough Time (BDT) is measured for specific chemotherapy drugs and fentanyl citrate according to ASTM D6978-05 (2019) and compared against specified minimum times.
- Biocompatibility: Assessed through in-vitro/in-vivo tests for irritation, sensitization (ISO 10993-10:2010), and acute systemic toxicity (ISO 10993-11:2017) to ensure no adverse biological reactions.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, 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 an AI/ML algorithm.
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(5 days)
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
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(86 days)
Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
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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(90 days)
Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
A powder-free patient examination 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 in accordance with ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 23.4 minute and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 77.5 minute. Warning statements has been included.
WARNING: DO NOT USE WITH CARMUSTINE WARNING: DO NOT USE WITH THIOTEPA
Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs." This document outlines the FDA's substantial equivalence determination for this medical device.
It does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI-powered diagnostic or similar system.
Instead, the document details the "Indications for Use" for the gloves, which includes their general purpose as examination gloves and their tested performance against specific chemotherapy drugs according to ASTM D6978-05.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, or training set details) from the provided text, as these are not relevant to this type of medical device submission.
The table in the document you provided describes the "Minimum Breakthrough Detection Time (Minutes)" for different chemotherapy drugs when tested with the gloves. This is a performance specification for the gloves regarding chemical permeation, not acceptance criteria for an AI product.
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(100 days)
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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 in accordance with ASTM D6978 standards.
The subject device is Nitrile Examination Gloves Sterile with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05(2019).
The provided document is a 510(k) Premarket Notification from the FDA regarding Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs.
This document does not describe the acceptance criteria and study proving a software algorithm device meets these criteria, but rather the acceptance criteria and test results for a physical medical device (examination gloves).
Therefore, many of the requested categories in your prompt (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, etc.) are not applicable to this type of device and the information provided in the 510(k) summary.
However, I can extract the relevant information about the acceptance criteria and the device's performance based on the provided document.
Device: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Type of Device: Physical Medical Device (Examination Gloves), Class I, reserved
Study Purpose: To demonstrate substantial equivalence to a predicate device (Riverstone Resources SDN BHD. Nitrile Examination Glove, Sterile Tested for use with Chemotherapy Drugs Claim, White (K190725)) by verifying that the subject device meets specific performance standards and has similar technological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents several tables detailing the acceptance criteria (standards/specifications) and the results indicating that the device meets these criteria.
| Item/Test | Acceptance Criteria (Standard/Specification) | Reported Device Performance (Results) |
|---|---|---|
| Dimensions | ||
| Length | Minimum 230mm | All size ≥290mm |
| Palm Width (XS) | 70 ± 10mm | 76-78mm |
| Palm Width (S) | 80 ± 10mm | 86-88mm |
| Palm Width (M) | 95 ± 10mm | 96-98mm |
| Palm Width (L) | 110 ± 10mm | 106-108mm |
| Palm Width (XL) | 120 ± 10mm | 116-118mm |
| Palm Width (XXL) | 130 ± 10mm | 126-128mm |
| Physical Properties (Thickness) | ||
| Thickness (Palm) | 0.05mm (min) | 0.09-0.11mm |
| Thickness (Finger) | 0.05mm (min) | 0.13-0.14mm |
| Physical Properties (Tensile Strength) | ||
| Tensile Strength, Before Aging | 14MPa, min | 15.8-20.8 MPa |
| Tensile Strength, After Accelerated Aging | 14MPa, min | 15.6-19.8 MPa |
| Physical Properties (Ultimate Elongation) | ||
| Ultimate Elongation, Before Aging | 500%, min | 500-560% |
| Ultimate Elongation, After Accelerated Aging | 400%, min | 400-500% |
| Integrity | ||
| Freedom from holes | G-I, AQL 2.5 (per ASTM D5151-19, ASTM D6319-19) | Meet and above AQL 2.5 requirements |
| Powder Content | ≤ 2 mg per glove (per ASTM D6124-06(2017), ASTM D6319-19) | ≤ 2 mg, meet requirements |
| Biocompatibility | ||
| Primary Skin Irritation Test | Not an irritant (per ISO 10993-10:2010) | Not an irritant |
| Dermal Sensitization Assay | Not a sensitizer (per ISO 10993-10:2010) | Not a sensitizer |
| Acute Systemic Toxicity Test | No evidence of systemic toxicity (per ISO 10993-11:2017) | No evidence of systemic toxicity |
| Chemotherapy Drug Permeation (Minimum Breakthrough Time - BDT) | ||
| Carmustine (BCNU) (3.3mg/ml) | - (Predicate: 39 min) | 54.3 minutes |
| Cyclophosphamide (20mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Doxorubicin Hydrochloride (2 mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Etoposide (20mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Fluorouracil (50mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Paclitaxel (6mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Thiotepa (10mg/ml) | - (Predicate: 97.6 min) | 196.7 minutes |
| Methotrexate (25mg/ml) | - (Predicate: >240 min) | >240 minutes |
| Cisplatin (1mg/ml) | - (Predicate: N/A) | >240 minutes |
| Vincristine Sulfate (1.0 mg/ml) | - (Predicate: N/A) | >240 minutes |
| Cytarabine HCL (100mg/ml) | - (Predicate: N/A) | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | - (Predicate: N/A) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | - (Predicate: N/A) | >240 minutes |
| Ifosfamide (50.0 mg/ml) | - (Predicate: N/A) | >240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | - (Predicate: N/A) | >240 minutes |
(Note: For chemotherapy drug permeation, the "Acceptance Criteria" are implied by comparison to the predicate device and showing equivalent or better performance. The exact criteria are not explicitly stated for each drug beyond the measured BDT.)
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "samples" in the way a software algorithm test set would be. The testing is based on batches of gloves or representative samples according to the referenced ASTM/ISO standards. For example, "Freedom from holes" testing follows an AQL (Acceptance Quality Limit) which implies a sampling plan.
- Data Provenance: The tests are non-clinical and conducted based on international standards (ASTM, ISO). The manufacturer is Grand Work Plastic Products Co., Ltd, located in Donggao Industrial Zone, Zanhuang, Hebei, China. The testing would have been performed there or at certified labs used by the manufacturer. The data is retrospective in the sense that it was collected as part of the device's development and qualification prior to the 510(k) submission.
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 physical device's performance (e.g., tensile strength, breakthrough time) is established by adherence to standardized physical and chemical testing methods (ASTM, ISO standards), not by human expert consensus or clinical judgment in the traditional sense of diagnostic AI. These standards define the test procedures and acceptance limits.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring human reader adjudication. Performance is measured by laboratory equipment and standard protocols.
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-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-based diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" is established through standardized physical, chemical, and biological testing methods as defined by:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06(2017) (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D6978-05(2019) (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs)
- ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- ISO 10993-11:2017 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
8. The sample size for the training set
Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning device.
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(155 days)
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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(Blue), Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
The provided document describes the acceptance criteria and performance data for "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs." This is a Class I medical device, and the testing focuses on its physical properties, biocompatibility, and resistance to chemotherapy drug permeation. It is crucial to note that this document pertains to a physical medical device (gloves) and not an AI/Software as a Medical Device (SaMD). Therefore, questions related to AI/SaMD specific aspects like expert data labeling, MRMC studies, training set data, etc., are not applicable to this submission. The information provided aligns with typical performance testing for physical devices.
Here's the breakdown of the acceptance criteria and reported performance, tailored to the available information:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Length | Minimum 230mm | All size ≥230mm |
| ASTM D6319-19 | Palm Width | XS: 70 ± 10mm | |
| S: 80 ± 10mm | |||
| M: 95 ± 10mm | |||
| L: 110 ± 10mm | |||
| XL: 120 ± 10mm | XS: 77-78mm | ||
| S: 86-88 mm | |||
| M: 96-98mm | |||
| L: 108-110 mm | |||
| XL: 116-117 mm | |||
| ASTM D6319-19 | Thickness | Finger: 0.05mm (min) | |
| Palm: 0.05mm (min) | ≥0.05mm | ||
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, Before Aging | 14MPa, min | ≥14 MPa |
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, After Accelerated Aging | 14MPa, min | ≥14 MPa |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, Before Aging | 500%, min | ≥500% |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, After Accelerated Aging | 400%, min | ≥400% |
| ASTM D5151-19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5 requirements |
| ASTM D6124-06 (2017) | Powder-Content | ≤2 mg per glove | ≤2 mg, meet requirements |
| ISO 10993-10:2010 | Skin Irritation Study | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant |
| ISO 10993-10:2010 | Maximization Sensitization Study | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO 10993-5:2009 | Cytotoxicity Test | Under the conditions of this study, the test article extract showed potential toxicity | Under the conditions of this study, the test article extract showed potential toxicity |
| ISO 10993-11:2017 | Systemic toxicity | Under the conditions of this study, there was no evidence of systemic toxicity. | Under the conditions of this study, there was no evidence of systemic toxicity. |
| ASTM D6978-05 (2019) | Tested for Use with Chemotherapy Drugs (Minimum BDT) | No explicit numerical acceptance criteria for each drug are listed as "acceptance criteria" in the table. The table provides the reported values for the device. The "Acceptance Criteria" column for this test indicates "/", implying that the objective is to report the measured breakthrough times. Note: For Carmustine (BCNU) and Thio Tepa, the document explicitly states a warning due to "extremely low permeation times." | Bleomycin (15.0mg/ml): >240 |
| Bortezomib (Velcade) 1mg/ml: >240 | |||
| Busulfan (6.0mg/ml): >240 | |||
| Carboplatin, (10.0mg/ml): >240 | |||
| Carmustine(BCNU) (3.3 mg/ml): 7.0 minutes | |||
| Chloroquine, (50.0mg/ml): >240 | |||
| Cisplatin (1mg/ml): >240 | |||
| Cyclophosphamide (Cytoxan) (20mg/ml): >240 | |||
| Cyclosporin, (100.0mg/ml): >240 | |||
| Cytarabine, (100.0mg/ml): >240 | |||
| Dacarbazine (10mg/ml): >240 | |||
| Daunorubicin, HCL (5.0mg/ml): >240 | |||
| Docetaxel, (10.0mg/ml): >240 | |||
| Doxorubicin HCL (2mg/ml): >240 | |||
| Epirubicin HCL (Ellence), (2.0mg/ml): >240 | |||
| Etoposide (20mg/ml): >240 | |||
| Fludarabine, (25.0mg/ml): >240 | |||
| Fluorouracil (50mg/ml): >240 | |||
| Gemcitabine (38.0mg/ml): >240 | |||
| Idarubicin HCL (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 | |||
| Methotrexate (25mg/ml): >240 | |||
| Mitomycin C, (0.5mg/ml): >240 | |||
| Mitoxantrone, (2.0mg/ml): >240 | |||
| Oxaliplatin, (5.0mg/ml): >240 | |||
| Paclitaxel (Taxol) (6mg/ml): >240 | |||
| Paraplatin, (10.0mg/ml): >240 | |||
| Retrovir, (10.0mg/ml): >240 | |||
| Rituximab, (10.0mg/ml): >240 | |||
| Thio Tepa (10mg/ml): 23.0 minutes | |||
| Topotecan HCL, (1.0mg/ml): >240 | |||
| Trisonex, (1.0mg/ml): >240 | |||
| Vincristine, (1.0mg/ml): >240 |
Regarding the AI/SaMD specific questions, the following points are not applicable as this document describes performance testing for a physical medical glove.
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 the exact sample sizes for each physical test (e.g., how many gloves were tested for tensile strength, or how many samples for biocompatibility). Standard test methods (ASTM, ISO) typically define minimum sample sizes. The data provenance is implied to be from testing labs in relation to the manufacturer (Shanxi Hongjin Plastic Technology Co., Ltd. in China) and their US representative. This is a prospective testing of 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. Ground truth for physical device performance is established by standardized laboratory testing methods (ASTM, ISO) rather than expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically relevant for human-in-the-loop assessments or expert consensus in image interpretation, not for physical material 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/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/SaMD. The "standalone" performance here refers to the physical properties of the glove itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The 'ground truth' for this device is based on objective measurements derived from standardized testing protocols (ASTM and ISO standards) measuring physical properties (like length, thickness, tensile strength, freedom from holes, powder content) and chemical resistance (breakthrough time for chemotherapy drugs), as well as biological responses (irritation, sensitization, cytotoxicity, systemic toxicity).
8. The sample size for the training set
- Not applicable. This is not an AI/SaMD, so 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 physical device testing, there is no ground truth establishment method for it.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of non-clinical performance tests conducted in accordance with recognized international (ISO) and national (ASTM) standards. These tests assess the physical, chemical, and biological properties of the nitrile examination gloves.
The "Non-Clinical Performance Data" section (Page 9 of the document) explicitly lists the test methods used, their purpose, the acceptance criteria, and the results, confirming that the proposed device complies with these standards. For example, ASTM D6319-19 was used for dimensions and tensile properties, ASTM D5151-19 for freedom from holes, ASTM D6124-06 for powder content, and ASTM D6978-05 (Reapproved 2019) for chemotherapy drug permeation. Biocompatibility was assessed using ISO 10993 series standards (Parts 5, 10, and 11) for cytotoxicity, irritation, sensitization, and systemic toxicity.
The conclusion states, "The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device." This indicates that the results met the established benchmarks (which are often derived from the requirements of the standards themselves or comparison to a predicate device).
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(186 days)
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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.
The proposed device was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with proposed device.
| Test Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| *Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.1 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 |
| Dacarbazine(DTIC) | 10.0 mg/ml (10,000ppm) | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml(20,000 ppm) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml(2,000 ppm) | >240 |
| Etoposide (Toposar) | 20.0 mg/ml(20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 |
| Mechlorethamine HCl | 1.0 mg/ml(1,000 ppm) | >240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 |
| *Thiotepa | 10.0 mg/ml(10,000 ppm) | 15.1 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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.
This document is a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs." It's a regulatory document for a medical device and not a study proving the device meets acceptance criteria for an AI/CADe product.
Therefore, the requested information about acceptance criteria for an AI/CADe study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to this document.
However, I can extract the acceptance criteria and performance related to the chemotherapy drug permeation testing for the gloves, as described in the document.
Here's the relevant information from the document as it pertains to the device (gloves), not an AI/CADe system:
1. A table of acceptance criteria and the reported device performance:
The document states that the device was "tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard would define the acceptance criteria for breakthrough detection time. While the specific numerical acceptance criteria (e.g., "must be >X minutes") are not explicitly stated in this document, the reported performance is the "Breakthrough Detection Time in Minutes." Implicitly, a longer breakthrough time is better.
| Test Chemotherapy Drug | Concentration | Reported Breakthrough Detection Time in Minutes |
|---|---|---|
| *Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.1 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | >240 |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml (20,000 ppm) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | >240 |
| Etoposide (Toposar) | 20.0 mg/ml(20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 |
| Mechlorethamine HCl | 1.0 mg/ml(1,000 ppm) | >240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 |
| *Thiotepa | 10.0 mg/ml(10,000 ppm) | 15.1 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
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 specify the sample size used for testing each chemotherapy drug. This is a regulatory submission for a medical device (gloves), not an AI algorithm. The provenance would be from laboratory testing according to the ASTM D6978-05 standard.
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 a physical product (gloves) tested for chemical permeation, not an AI algorithm requiring expert ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This pertains to the resolution of disagreements among experts in AI/clinical studies, which is not relevant here.
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/CADe product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/CADe product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the gloves' performance is established by the laboratory measurement of chemotherapy drug permeation using the standardized method ASTM D6978-05. This involves quantitative detection of the drug passing through the glove material.
8. The sample size for the training set
Not applicable. This is not an AI/CADe product, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/CADe product, so there is no "training set" or corresponding ground truth establishment.
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(119 days)
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs
The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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. The proposed device was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
The document describes the FDA 510(k) clearance for "Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs" and provides details about the testing conducted to support its substantial equivalence.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the study described relates to the glove's resistance to permeation by chemotherapy drugs. The acceptance criterion is implicit in the testing standard used, ASTM D6978-05 (Reapproved 2013), which generally aims for a breakthrough detection time that is sufficient for practical use in a clinical setting (often implying a minimum of 30 minutes, or longer for most drugs).
| Test Chemotherapy Drug | Concentration | Acceptance Criteria (Implied by standard and industry practice) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | Breakthrough > 30 minutes (typical for critical drugs) | 35.3 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml (20,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Mechlorethamine HCl | 1.0 mg/ml (1,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Thiotepa | 10.0 mg/ml (10,000 ppm) | Breakthrough > 30 minutes (typical for critical drugs) | 29.2 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
Note: For FDA 510(k) clearances, performance is compared to a predicate device and/or recognized standards. The "acceptance criteria" here are inferred from the standard and the reported results within the context of safe medical device use. For chemotherapy gloves, the general expectation is that the breakthrough time should be sufficient to allow safe handling, typically indicating more than 30 minutes, and ideally much longer (e.g., >240 minutes) for many drugs. The results show that for most listed drugs, the glove exceeded 240 minutes, while for Carmustine and Thiotepa, it met or nearly met a 30-minute threshold.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for testing each chemotherapy drug. The testing was performed in accordance with ASTM D6978-05 (Reapproved 2013). This standard specifies the methodology for assessing permeation, which would include details on the number of specimens to be tested per drug, but this specific detail is not provided in the publicly available 510(k) letter.
Data Provenance: The study was conducted by Blue Sail Medical Co.,Ltd, located in Zibo, CN (China). The data is prospective in nature, as it involves laboratory testing of the manufactured device to assess its performance against a standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and study. The "ground truth" for chemical permeation testing is established by laboratory measurement using standardized methods (ASTM D6978-05), not by expert consensus or interpretation of clinical data. The "experts" would be the chemists or technicians performing and verifying the lab tests, who would have qualifications in analytical chemistry and material science.
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 involving interpretation of medical images or data by multiple human readers. This study is a laboratory performance test based on physical and chemical properties.
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 relates to diagnostic accuracy or clinical effectiveness involving human readers and interpretations, which is not relevant to the chemical permeation resistance of gloves.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is irrelevant to the device. "Standalone performance" refers to the performance of an AI algorithm without human input. The device is a physical medical glove, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is laboratory measurement data based on the standardized methodology of ASTM D6978-05 (Reapproved 2013). This standard defines how "breakthrough detection time" is measured, which is a quantified performance metric.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of physical medical devices like gloves. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a physical medical device.
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