(86 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.
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Pre-powder Vinyl Patient Examination Glove, 80LYZ , powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
The provided text describes the submission for a 510(k) premarket notification for "SHANGHAI COSMOS CORP. Pre-powdered Vinyl Examination Gloves". This document focuses on the substantial equivalence of the device to a predicate device and adherence to established standards for medical examination gloves. It is not a study describing AI performance or an AI-powered device. Therefore, most of the questions regarding AI-specific criteria cannot be answered from the provided text.
Here's an analysis based on the information provided, recognizing that the core request for AI-specific criteria is largely unaddressable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM D-5250-92 (Physical and Dimensions) | Meets all requirements (Inspection Level S-2, AQL 4.0) |
| FDA 1000 ml. Water Fill Test | Meets requirements (Samplings of AQL 2.5, Inspection Level S-4) |
| Primary Skin Irritation Testing | Results showing no primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) Testing | Results showing no sensitization reactions |
| 21 CFR references (e.g., GMPs) | Operates in compliance with FDA's GMPs; conforms fully to applicable 21 CFR references |
| Pinhole FDA requirements | Meets pinhole FDA requirements |
| Bio-compatibility requirements | Meets bio-compatibility requirements |
| Labeling claims | Meets labeling claims (no special or hypoallergenic claims) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- For Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0 (specific sample size from this AQL is not provided, but it's a standard sampling plan).
- For FDA 1000 ml. Water Fill Test: Samplings of AQL 2.5, Inspection Level S-4 (specific sample size from this AQL/Inspection Level is not provided).
- For Primary Skin Irritation and Skin Sensitization: Sample sizes are not explicitly mentioned.
- Data Provenance: The tests were conducted for "SHANGHAI COSMOS CORP. Production" which is based in Shanghai, China. The document does not specify if the testing was performed in China or elsewhere, or if it was retrospective or prospective. Given it's a pre-market submission, it would be prospective testing 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)
This question is not applicable. The device is a physical product (examination gloves), and its performance is evaluated against material standards and explicit physical/biological tests, not by expert consensus on interpretations of data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of images or data where subjective interpretation is involved. For physical product testing against objective standards, such adjudication is not relevant.
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 question is not applicable. This is concerning an examination glove, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is concerning an examination glove, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by:
- ASTM Standard D5250-92: This standard sets objective physical and dimensional properties (e.g., tensile strength, elongation, dimensions, freedom from holes).
- FDA 1000 ml. Water Fill Test: An objective test for pinhole integrity.
- Bio-compatibility testing: Objective tests for primary skin irritation and sensitization.
- 21 CFR requirements: Compliance with regulatory manufacturing and quality standards (e.g., GMPs).
8. The sample size for the training set
This question is not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable. This is not an AI device that requires a training set.
§ 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.