(91 days)
The nitrile examination glove is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
This document pertains to the 510(k) premarket notification for "Nitrile Examination Gloves" by Wuhan Huirui Technology Co., Ltd. The submission argues for substantial equivalence to a predicate device (K203593) based on non-clinical testing.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S:≥220; M/L/XL:≥230; Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10; Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Length: > 230 (Pass); Width: S: 83-87 (Pass), M: 93-97 (Pass), L: 102-107 (Pass), XL: 113-117 (Pass); Thickness: Finger: 0.08-0.09 (Pass), Palm: 0.06 (Pass) | Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 (Pass) | Pass |
| 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.