(92 days)
The 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 is clear. 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 Vinyl Examination Gloves, not an AI/ML medical device. Therefore, the information requested in the prompt regarding AI/ML device acceptance criteria and study details (such as sample sizes for test and training sets, expert ground truth, multi-reader multi-case studies, etc.) is not applicable and cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence of the Vinyl Examination Gloves to a predicate device through non-clinical performance testing.
Here's a breakdown of the non-clinical acceptance criteria and reported performance, as directly extractable from the provided text, adapted to the table format requested:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test (Length) | Length(mm): S/M/L/XL: ≥ 230 | Length(mm): > 230/Pass |
| ASTM D6319 | Physical Dimensions Test (Width) | Width(mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | Width(mm): S: 80-89 /Pass; M: 90-98/ Pass; L: 100-107/ Pass; XL:111-118/ Pass |
| ASTM D6319 | Physical Dimensions Test (Thickness) | Thickness (mm): Finger: ≥ 0.08; Palm: ≥ 0.08 | Thickness (mm): Finger: 0.08-0.17/Pass; Palm: 0.08/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.