(43 days)
The Disposable Nitrile 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 nitrile examination gloves. The subject device is blue. It can be available in five specifications: XS, S, M, L and XL. The subject device is non-sterile.
The provided document is a 510(k) Premarket Notification for a Disposable Nitrile Examination Glove, not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria and study designs that are specific to AI/ML device performance (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable.
The document focuses on demonstrating substantial equivalence of the new glove to a legally marketed predicate device based on material, performance, and biocompatibility standards.
Here's a breakdown of the relevant information from the document related to performance and acceptance criteria for this non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): XS/S: ≥220; M/L/XL: ≥230; Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10; Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Length (mm): > 230 / Pass; Width (mm): XS: 74-77 / Pass; S: 85-86 / Pass; M: 94-97 / Pass; L: 103-108 / Pass; XL: 114-118 / Pass; Thickness (mm): Finger: 0.08-0.09 / Pass; Palm: 0.06-0.07 / Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 / Pass (This likely means 0 failures out of 125 samples, meeting AQL 2.5) |
| 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.