(5 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 Pink/Cool Gary/Green/Rose Gold. 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 a Disposable Nitrile Examination Glove. It details the device, its intended use, and non-clinical testing performed to establish substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D6319 - Physical Dimensions | Length (mm): S: ≥220; M/L/XL: ≥230 | Length (mm): >230/Pass (for all sizes M, L, XL) |
| (Note: S-size length not explicitly stated as >230 but presumably passed since the general length is >230 mm) | ||
| Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | Width (mm): S: 84-89 /Pass; M: 94-97/ Pass; L: 104-111/ Pass; XL:113-116/ Pass | |
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Thickness (mm): Finger: 0.12-0.14/Pass; Palm: 0.11-0.13/Pass | |
| ASTM D5151 - Watertightness (Holes) | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | 0/125/Pass (This implies 0 failures out of 125 samples, meeting the AQL) |
| 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.