(52 days)
A 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 are worn to protect the wearer against exposure to chemotherapy drugs.
Nitrile Powder-Free Examination Gloves are formulated using nitrile and offered powder-free.
This document describes the safety and effectiveness of "Nitrile Powder-Free Examination Gloves" and does not relate to artificial intelligence or machine learning devices. Therefore, most of the requested information (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies, standalone algorithm performance, adjudication methods, details about AI-related ground truth) is not applicable to this submission.
However, I can extract and present the information that is relevant to the acceptance criteria and the summary of testing for these medical gloves.
Acceptance Criteria and Device Performance for Nitrile Powder-Free Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | Not explicitly stated, but implied as "no irritation" | Gloves show no irritation. |
| Guinea Pig Maximization | Not explicitly stated, but implied as "no potential for irritation" | Gloves do not display any potential for irritation. |
| Tensile Strength | Meet or exceed requirements per ASTM D6319-00a | Gloves meet or exceed requirements per ASTM D6319-00a. |
| Barrier Defects | Meet or exceed requirements per 21 CFR§800.20 and ASTM D6319-00a | Gloves meet or exceed requirements per 21 CFR§800.20 and ASTM D6319-00a. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided document for any of the tests.
- Data Provenance: Not specified. Standard practice for these tests is typically prospective testing of manufactured batches.
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 as this is not an AI/ML device requiring expert ground truth for interpretation of complex data. The "ground truth" for glove performance tests is determined by standardized physical and biological testing methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. These are laboratory tests with objective outcomes based on 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:
- Not applicable. 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. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" is established by the specified standards and regulations:
- Primary Skin Irritation & Guinea Pig Maximization: Biological tests to assess skin reactions, interpreted by trained personnel following toxicological guidelines (implied).
- Tensile Strength: Objective measurement against specifications defined in ASTM D6319-00a.
- Barrier Defects: Objective measurement against specifications defined in 21 CFR§800.20 (Pinholes in Medical Gloves) and ASTM D6319-00a.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
Summary of Safety and Effectiveness Explanation (Based on Provided Text):
The "Nitrile Powder-Free Examination Gloves" were determined to be substantially equivalent to the predicate device (Flexam Nitrile T Ambi Examination Gloves, Allegiance Healthcare Corp.) based on shared characteristics and testing results. The device's safety and effectiveness were demonstrated by laboratory testing confirming:
- No primary skin irritation.
- No potential for irritation in a guinea pig maximization test.
- Conformity to or exceeding the tensile strength requirements of ASTM D6319-00a.
- Conformity to or exceeding the barrier defect requirements of 21 CFR§800.20 and ASTM D6319-00a.
These tests ensure the gloves perform their intended function of preventing contamination and protecting the wearer, without causing adverse biological reactions, and meet the mechanical and barrier integrity standards for medical examination gloves.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.