(113 days)
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General Hospital and Personal Use Device panel as Class I. 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.
The provided text describes a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves" and is not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, sample size, and expert involvement for AI/ML device testing is not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device by meeting established ASTM standards and FDA requirements for patient examination gloves.
However, I can extract the closest analogous information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ASTM D-5250-06e1 (Physical and Dimensions Testing) | Meets all requirements (Section 7) |
| FDA 1000 ml Water Fill Test (AQL 2.5, Inspection Level I) | Meets requirements (Section 7) |
| Primary Skin Irritation | No primary skin irritant reactions (Section 7) |
| Skin Sensitization | No sensitization reactions (Section 7) |
| Residual Powder Test (ASTM D-6124-06) | Meets "powder-free" claims ( |
§ 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.