(104 days)
The Disposable Nitrile Medical 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. The subject device is non-sterile.
This document describes the premarket notification for the "Disposable Nitrile Medical Examination Glove". The acceptance criteria and the study proving the device meets these criteria are detailed through a series of tables and text.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 - Physical Dimensions Test | Pass for all sizes | ||
| Length (mm) | ≥ 230 | XS, S, M, L, XL: > 230 | |
| Width (mm) | XS: 75 ± 5 | ||
| S: 85 ± 5 | |||
| M: 95 ± 5 | |||
| L: 105 ± 5 | |||
| XL: 115 ± 5 | XS: 77-79 | ||
| S: 82-86 | |||
| M: 95-97 | |||
| L: 104-106 | |||
| XL: 115-117 | |||
| Thickness (mm) - Finger | ≥ 0.05 | XS: 0.10-0.12 | |
| S: 0.09-0.12 | |||
| M: 0.08-0.12 | |||
| L: 0.09-0.13 | |||
| XL: 0.11-0.12 | |||
| Thickness (mm) - Palm | ≥ 0.05 | XS: 0.06-0.10 | |
| S: 0.07-0.09 | |||
| M: 0.06-0.09 | |||
| L: 0.06-0.09 | |||
| XL: 0.06-0.08 | |||
| ASTM D5151 - Watertightness Test for Detection of Holes | Freedom from Holes | Meet the requirements of ASTM D5151 AQL 2.5 | XS: 0/125 leaks |
| S: 1/125 leaks | |||
| M: 0/125 leaks (Implied Pass based on AQL 2.5) | |||
| ASTM D6124 - Powder Content | 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.