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510(k) Data Aggregation
(86 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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, Powder-free Vinyl Patient Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.
This is a 510(k) premarket notification for "SHANGHAI COSMOS CORP. Powder-free Vinyl Patient Examination Gloves". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study following the user's specific request for AI/ML device testing criteria. Therefore, most of the requested information regarding AI/ML device performance and study design cannot be extracted from this document, as it is not relevant to a glove 510(k) submission.
However, I can provide information based on the typical requirements for patient examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM D5250-92) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (AQL 4.0, Inspection Level S-2) | Met requirements |
| Pinhole FDA Requirements (AQL 2.5, Inspection Level S-4, 1000 ml Water Fill Test) | Met requirements |
| Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions |
| Powder-free claim (USP Iodine Test for Starch & Particulate testing) | Met (powder-free claim adhered to, particulate testing contracted) |
| Biocompatibility requirements | Met requirements (implied by skin irritation/sensitization tests) |
| Labeling claims | Met requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "samplings of AQL 2.5, Inspection Level S-4" for the FDA 1000 ml. Water Fill Test and "Inspection Level S-2, AQL 4.0" for Physical and Dimensions Testing. The specific sample sizes for these AQL (Acceptable Quality Level) levels would be determined by the standard ASTM D5250-92 and the batch size of the gloves, but the exact number is not explicitly stated in this summary.
Data Provenance: Not applicable for this type of product as it's not data-driven in the way an AI/ML device would be. The testing is performed on the manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for glove performance is established by the specified ASTM standards and FDA requirements, not by expert consensus on interpretations.
4. Adjudication Method for the Test Set
Not applicable. Physical and chemical tests are objective and do not typically involve adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is not an AI/ML device, and an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This refers to an AI/ML device, which this product is not.
7. The Type of Ground Truth Used
The ground truth is based on:
- ASTM D-5250-92 standards for physical properties and dimensions.
- FDA pinhole requirements (1000 ml water fill test).
- Results from biocompatibility tests (primary skin irritation and sensitization).
- USP Iodine Test methodology for powder-free claims.
8. The Sample Size for the Training Set
Not applicable. This is a non-AI/ML device.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is a non-AI/ML device.
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(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.
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