(82 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free synthetic Nitrile patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.
The document describes the Edma Synthetic Nitrile Examination Gloves (K211540) and their acceptance criteria through non-clinical testing.
Here's the breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions | Length: ≥230mm; Width (M: 95±10, L: 110±10, XL: 120±10); Thickness (Finger: ≥0.08mm, Palm: ≥0.08mm) | Length: >230mm; Width (M: 96-99, L: 106-109, XL: 114-118); Thickness (Finger: 0.08-0.13mm, Palm: 0.08-0.09mm). Pass |
| ASTM D5151 | Watertightness | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks. 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.