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510(k) Data Aggregation
(118 days)
Chifeng Huawei Medical Science&Technology Co.,Ltd.
The DISPOSABLE VINYL EXAMINATION GLOVE is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl examination gloves. The subject device's color is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided text describes the acceptance criteria and the study conducted for a Disposable Vinyl Examination Glove (K220469).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length (mm): S/M/L/XL: ≥230; Width (mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5; Thickness (mm): Finger: ≥0.08, Palm: ≥0.08 | Length (mm): > 230/Pass; Width (mm): S: 85-89 /Pass, M: 95-97/ Pass, L: 104-107/ Pass, XL: 116-118/ Pass; Thickness (mm): Finger: 0.11-0.17/Pass, Palm: 0.10-0.13/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 |
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(174 days)
Chifeng Huawei Medical Science & Technology Co., Ltd
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 |
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