(174 days)
The Disposable Nitrile Examination Gloves 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 describes the premarket notification for Disposable Nitrile Examination Gloves (K212833). Here's an analysis of the acceptance criteria and study information provided:
Acceptance Criteria and Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length: S: $\ge$ 220 mm; M/L/XL: $\ge$ 230 mm | |
| Width: S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; XL: 120 ± 10 mm | |||
| Thickness: Finger: $\ge$ 0.05 mm; Palm: $\ge$ 0.05 mm | Length: > 240 mm (Pass) | ||
| Width: S: 86-89 mm (Pass); M: 96-101 mm (Pass); L: 107-110 mm (Pass); XL: 116-119 mm (Pass) | |||
| Thickness: Finger: 0.10-0.12 mm (Pass); Palm: 0.08-0.09 mm (Pass) | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 (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.