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510(k) Data Aggregation
(66 days)
Jiangxi Handspro Products Solutions CO., LTD.
The Disposable Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is in blue color. 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 Nitrile Examination Gloves. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study findings based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 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: S: >220/Pass; M/L/XL: >230/Pass; Width: S: 82-88 /Pass; M: 95-98/ Pass; L: 106-111/ Pass; XL:111-115/ Pass; Finger Thickness: 0.13-0.15/Pass; Palm Thickness: 0.09-0.12/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL=2.5 | 0/125/Pass (This implies 0 holes found in 125 samples, meeting the AQL of 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 |
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(9 days)
Jiangxi Handspro Products Solutions 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 non-colored vinyl examination glove. 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 that proves a "Disposable Vinyl Examination Glove" meets these criteria. It is important to note that this is a Class I medical device (non-AI/ML).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length: S/M/L/XL: ≥230mm | |
| Width: S: 85±5mm; M: 95±5mm; L: 105±5mm; XL: 115±5mm | |||
| Thickness: Finger: ≥0.08mm; Palm: ≥0.08mm | Length: >230mm / Pass | ||
| Width: S: 84-87mm / Pass; M: 92-96mm / Pass; L: 103-106mm / Pass; XL: 112-117mm / Pass | |||
| Thickness: Finger: 0.13-0.15mm / Pass; Palm: 0.09-0.12mm / Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | AQL 2.5 | 0/125 / Pass |
| ASTM D6124 | Powder Content |
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