(121 days)
The Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in six specifications: XS,S,M,L XL and XXL. The subject device is non-sterile.
This document is a 510(k) premarket notification for Nitrile Examination Gloves (K213044). It describes the non-clinical testing performed to demonstrate that the device meets acceptance criteria and is substantially equivalent to a predicate device (K171422).
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): XS/S: ≥ 220; M/L/XL/XXL: ≥ 230 | |
| Width (mm): XS: 70 ± 10; S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10; XXL: 130 ± 10 | |||
| Thickness (mm): Finger: ≥ 0.05; Palm: ≥ 0.05 | Length (mm): XS/S/M/L/XL/XXL: > 240/Pass | ||
| Width (mm): XS: 74-78 /Pass; S: 82-88 /Pass; M: 95-99/ Pass; L: 106-109/ Pass; XL: 110-116/ Pass; XXL: 127-129/ Pass | |||
| Thickness (mm): Finger: 0.16-0.18/Pass; Palm: 0.12-0.14/Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Be free from holes when tested in accordance with ASTM D5151, AQL=2.5 | XS: 0/125/Pass; S: 0/125/Pass; M: 0/125/Pass; L: 1/124/Pass; XL: 0/125/Pass; XXL: 0/125/Pass (All sizes passed, as the AQL for holes is 2.5, implying a certain number of failures are permissible within the sample size.) |
| ASTM D6124 | Powder Content | Meet the requirements of 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.