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510(k) Data Aggregation
(20 days)
These Powder Free, Nitrile Examination Gloves are a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
US Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are Blue, Polymer coated, Nonsterile, Powder Free, Ambidextrous Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs. These are made up of 100% synthetic Nitrile Butadiene Latex. Its surface finish is finger textured with beaded cuff.
The provided text describes the acceptance criteria and performance data for Memorial™ Gloves, which are Powder Free, Nitrile Examination Gloves. The submission is a 510(k) premarket notification to the FDA, indicating a claim of substantial equivalence to already marketed predicate devices.
Here's an analysis of the provided information, framed by your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents several tables summarizing non-clinical tests. I will consolidate the key information from pages 15-17.
| Testing/Standards (Parameter) | Purpose of the Test | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Physical Properties | |||
| ASTM D-3767 (Dimensions: Length, Width, Thickness) | To determine the length, width and thickness of the gloves | US Glove Supply's Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) should meet the requirements of ASTM D6319. | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Specific values: Length Min 230mm, Width S 80, M 95, L 110, XL 120, Thickness (Cuff: 0.05 ± 0.02, Palm: 0.07 ± 0.02, Finger: 0.09 ± 0.02)) |
| ASTM D-412/D-573 (Tensile Strength & Elongation) | To determine the Tensile strength and elongation in gloves before aging and after aging | Before aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 500%min. After aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 400%min. | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Specific values are stated to meet these criteria, consistent with the acceptance criteria.) |
| ASTM D-5151 (Leakage/Detection of Holes) | Testing for freedom from holes as per ASTM D-5151. | The gloves should be free of holes (Meets with the requirement of ASTM D 5151, following ASTM D 6319 AQL 2.5/Inspection Level G-I). | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Stated as meeting ASTM D 5151, following ASTM D 6319 AQL 2.5/Inspection Level G-I) |
| ASTM D6124 (Powder Content) | To Determine the powder residue using Test Method D6124. | 2.0 mg Maximum | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D6319. (Specific value stated as Max 1.38 mg/glove, which is < 2.0 mg) |
| Chemical Permeation | |||
| ASTM D6978-05 (2019) (Permeation Testing for Chemotherapy Drugs) | To determine the Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | Should meet the requirements as per ASTM D 6978-05. (Specific minimum breakthrough detection times for listed drugs, e.g., No breakthrough for up to 240 minutes for most, Carmustine = 14.9 min, Thio-Tepa = 37.8 min). | Pass. Powder Free, Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) meets the requirements of ASTM D-6978-05. (Specific results include: Cyclophosphamide, Doxorubicin HCl, Etoposide, 5-Fluorouracil, Paclitaxel, Cisplatin, Dacarbazine, Methotrexate, Mitomycin C, Vincristine Sulfate: No breakthrough for up to 240 minutes. Carmustine (BCNU): Min minutes before breakthrough = 14.9. Thio-Tepa: Min minutes before breakthrough = 37.8. Warnings are noted for Carmustine and Thio-Tepa due to low permeation times.) |
| Biocompatibility | |||
| ISO 10993-23 (Primary Skin Irritation) | To evaluate the local dermal irritation of a test article extract following intracutaneous injection in rabbits. | Under the condition of study not an irritant. | Under the conditions of the study, the test article met the requirements of the test. |
| ISO 10993-10 (Dermal Sensitization) | To evaluate the test item, for the skin sensitization in Guinea pigs by maximization test. | Under the conditions of the study, not a sensitizer. | Under the conditions of the study, the test article was not considered a sensitizer. |
| ISO 10993-5 (In Vitro Cytotoxicity) | To determine the potential of a test article to cause cytotoxicity. | Under the conditions of the study, non-cytotoxic. | Based on the results obtained under laboratory testing conditions, test item extracts of Nitrile Examination Gloves was found to be "cytotoxic" at 100% and 50% extract and "non-cytotoxic" at 25%, 12.5% and 6.25% test item extracts to the subconfluent monolayer of L-929 mouse fibroblast cells. (This indicates partial cytotoxicity at higher concentrations). |
| ISO 10993-11 (Acute Systemic Toxicity) | To evaluate the acute systemic toxicity of a test article, extract following injection in mice. | Under the conditions of study, the device extracts do not pose a systemic toxicity concern. | Under the conditions of study, there was no mortality or evidence of acute systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each individual test (e.g., number of gloves tested for permeation, number of animals for biocompatibility). It generally states that the tests "meet the requirements of" the respective ASTM or ISO standards, which typically implies that the sample sizes specified by those standards were followed.
The data provenance is non-clinical testing, performed to meet specific international and US standards. The document doesn't specify the country of origin of the data beyond the standards themselves. The tests are prospective in the sense that they were specifically conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this device submission. This is a 510(k) for examination gloves, which relies on well-established performance standards (ASTM, ISO) for physical, chemical, and biocompatibility properties, not on expert adjudication of subjective results (like image interpretation).
4. Adjudication Method for the Test Set
This is not applicable. The tests performed are objective, quantitative measurements (e.g., tensile strength, breakthrough time, cytotoxicity levels) against predefined acceptance criteria from international standards. There is no expert adjudication process for these types of tests.
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 device is not an AI/ML-enabled medical device. Therefore, a MRMC comparative effectiveness study is not applicable and was not performed. The device is a physical product (gloves) whose performance is evaluated against material and barrier properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable, as the device is not an algorithm or AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this product is derived from established international and laboratory standards (ASTM, ISO). These standards define the scientific methods and criteria for evaluating the physical, chemical resistance, and biocompatibility of medical gloves. For example:
- Physical properties: Measured parameters (length, width, thickness, tensile strength, elongation, freedom from holes, powder content) are compared against the numerical specifications in ASTM D6319 and D5151/D6124.
- Chemotherapy drug permeation: Breakthrough times are objectively measured according to ASTM D6978-05.
- Biocompatibility: In vitro and in vivo tests (irritation, sensitization, cytotoxicity, systemic toxicity) follow ISO 10993 series to assess biological responses, with predefined criteria for "irritant," "sensitizer," "cytotoxic," etc.
8. The Sample Size for the Training Set
This is not applicable. The device is not an AI/ML product and does not involve training data sets.
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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