(230 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Powder-free Vinyl Patient Examination Gloves, Yellow Color. A disposable device intended for medical purposes that is worn upon the examiner's hands or finger. Prevent contamination between patient and examiner. Cover the hand and wrist area. Covers have separate sheaths or openings for each finger and the thumb.
This document is a 510(k) summary for a medical device: Powder-free Vinyl Patient Examination Gloves, Yellow Color. It focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "device" in this context is the glove itself, not an AI or software-based medical device.
As a result, most of the requested information regarding AI/ML device studies (such as sample sizes for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established) is not applicable to this type of medical device filing.
However, I can extract the acceptance criteria and reported performance for the physical characteristics of the gloves based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally "Confirmed with ASTM D5250-06" or "Meet ASTM D5250-06" for physical properties and "Meet ASTM D6124-06" for residual powder. For biocompatibility, the criteria are "Not a sensitizer" and "Not an irritant." The reported device performance indicates that the proposed device meets these standards.
| Acceptance Criteria / Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Properties (per ASTM D5250-06): | ||
| Length on Large Size | Confirmed with ASTM D5250-06 | Confirmed with ASTM D5250-06 |
| Width of Palm on Large Size | Confirmed with ASTM D5250-06 | Confirmed with ASTM D5250-06 |
| Palm Thickness | Confirmed with ASTM D5250-06 | Confirmed with ASTM D5250-06 |
| Fingertip Thickness | Confirmed with ASTM D5250-06 | Confirmed with ASTM D5250-06 |
| Pinhole Results | Meet ASTM D5250-06 | Meet ASTM-D-5250-06 |
| Before Aging: Tensile Strength(Mpa) and Ultimate Elongations | Meet ASTM D5250-06 | Meet ASTM D5250-06 |
| After Aging: Tensile Strength(Mpa) and Ultimate Elongations | Meet ASTM D5250-06 | Meet ASTM D5250-06 |
| Other Non-Clinical Results: | ||
| Residual Powder | Meet ASTM D6124-06 (or |
§ 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.