(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.
§ 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.