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510(k) Data Aggregation
(47 days)
Anhui Bytech Medical Supplies Co., Ltd.
The DISPOSABLE VINYL EXAMINATION GLOVE (Pink, Black, Blue) 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 glove. The subject device's color is pink, black and blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.
The provided document is a 510(k) Premarket Notification for Disposable Vinyl Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device based on bench testing (non-clinical testing) rather than clinical studies involving human patients or complex AI algorithms.
Therefore, many of the requested points related to AI, MRMC studies, expert ground truth adjudication, and clinical trial specifics are not applicable to this submission.
Here's a breakdown of the requested information based on the provided document:
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: 83-87 / Pass; M: 92-97 / Pass; L: 104-106 / Pass; XL: 112-117 / Pass | |||
| Thickness (mm): Finger: 0.13-0.14 / Pass; Palm: 0.09-0.11 / Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 / Pass (This indicates 0 holes found in 125 samples tested) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 |
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(339 days)
Anhui Bytech Medical Supplies Co., Ltd.
The Single-use medical poly (vinyl chloride) 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 proposed device is Powder Free Vinyl Patient Examination Gloves which is made of poly vinyl chloride. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
This document is a 510(k) Pre-Market Notification for a medical device: "Single-use medical poly (vinyl chloride) examination glove." It's primarily a comparison to a predicate device to establish substantial equivalence, not a study proving device meeting acceptance criteria in the context of advanced AI/medical imaging devices. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting the specifications of various ASTM and ISO standards for medical examination gloves. The reported device performance indicates that the proposed device meets these criteria.
| Test Item | Acceptance Criteria (Pass Criteria) | Reported Device Performance (Verdict) |
|---|---|---|
| Dimension (mm) | ASTM D5250 | Pass |
| Overall Length | Min 230 | >230/ Pass |
| Width | XS: 76±6; S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | XS: 79-81/ Pass; S: 85-87 /Pass; M: 95-97/ Pass; L: 105-107/ Pass; XL: 115-117/ Pass |
| Finger thickness | 0.05 | 0.09-0.12/ Pass |
| Palm thickness | 0.08 | 0.08-0.09/ Pass |
| Freedom from Holes | Meet the requirements of ASTM D5151 AQL 1.5 | 0/125, 1/ 125, 4/315, 5/500, 3/200 leaks / Pass (Implies AQL 1.5 met) |
| Powder Content | Meet the requirements of ASTM D6124 |
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