(112 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.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Gloves, LYZ, and meets all requirements of ASTM D5250-06.
This document is a 510(k) Pre-market Notification for Zibo Huiying Medical Products, Co. Ltd.'s "Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue". It aims to demonstrate substantial equivalence to a predicate device. The information provided heavily relies on non-clinical testing and comparison to established ASTM standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Predicate Device) | Reported Device Performance (Synmax Synthetic Patient Examination Vinyl Gloves) |
|---|---|
| Physical Properties (ASTM D5250, ASTM D6319) | |
| Before Aging: Tensile Strength: 16 Mpa min | Average Tensile Strength: 16.9 Mpa |
| Before Aging: Elongation: 500% min | Average Ultimate Elongations: 550% |
| After Aging: Tensile Strength: 14 Mpa min | Average Tensile Strength: 14.4 Mpa |
| After Aging: Elongation: 400% min | Average Ultimate Elongations: 500% |
| Overall Length on Medium Size: 230 mm min | Average over 234mm |
| Width of Palm on Medium Size: 95 ± 10 mm | Average 96mm |
| Palm Thickness: 0.05 mm min | Average 0.096 mm |
| Finger Thickness: 0.05 mm min | Average 0.98 mm |
| Residual Powder (ASTM D6124-06) | |
§ 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.