(82 days)
The Vinyl Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. The subject device is clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.
This document is a 510(k) Premarket Notification for Vinyl Patient Examination Gloves, asserting substantial equivalence to a predicate device (K163168). The acceptance criteria and supporting studies are primarily focused on physical and chemical performance standards for medical gloves, rather than AI/algorithm-based criteria.
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Subject Device) | Predicate Device Performance (K163168) | Comparison |
|---|---|---|---|
| Physical Dimensions (ASTM D5250) | |||
| Length, mm (min) | 230 (XS, S, M, L, XL) | 230 (XS, S), 235 (M), 245 (L, XL) | Different lengths for M, L, XL sizes, but all "meet the requirements of ASTM D5250" |
| Width, mm (±5) | 78 (XS), 85 (S), 95 (M), 105 (L), 115 (XL) | 80 (XS), 85 (S), 95 (M), 105 (L), 115 (XL) | Different for XS width, but all "meet the requirements of ASTM D5250" |
| Finger Thickness, mm (min) | 0.08 | 0.05 | Different, but subject device meets higher minimum. "Meet the requirements of ASTM D5250" |
| Palm Thickness, mm (min) | 0.08 | 0.08 | Same |
| Physical Properties (ASTM D5250) | |||
| Before Aging Tensile Strength | 11 MPa, min | 15 MPa, min | Different, but subject device meets ASTM D5250 requirements ["do not raise any new safety or performance questions"] |
| Before Aging Ultimate Elongation | 300% min | 380% min | Different, but subject device meets ASTM D5250 requirements ["do not raise any new safety or performance questions"] |
| After Aging Tensile Strength | 11 MPa, min | 15 MPa, min | Different, but subject device meets ASTM D5250 requirements ["do not raise any new safety or performance questions"] |
| After Aging Ultimate Elongation | 300% min | 380% min | Different, but subject device meets ASTM D5250 requirements ["do not raise any new safety or performance questions"] |
| Freedom from Holes (ASTM D5151) | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Same |
| Powder Content (ASTM D6124) |
§ 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.