(339 days)
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 |
§ 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.