(135 days)
The Nitrile Patient 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.
The provided document is a 510(k) summary for a Nitrile Patient Examination Glove, which is a Class I device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than complex clinical efficacy studies for novel devices.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): | Length (mm): |
| XS/S: ≥220 | XS/S: > 220 / Pass | ||
| M/L/XL/XXL: ≥230 | M/L/XL/XXL: > 230 / Pass | ||
| Width (mm): | Width (mm): | ||
| XS: 70 ± 10 | XS: 73-78 / Pass | ||
| S: 80 ± 10 | S: 80-84 / Pass | ||
| M: 95 ± 10 | M: 95-100 / Pass | ||
| L: 110 ± 10 | L: 109-114 / Pass | ||
| XL: 120 ± 10 | XL: 117-121 / Pass | ||
| XXL: 130 ± 10 | XXL: 125-128 / Pass | ||
| Thickness (mm): | Thickness (mm): | ||
| Finger: ≥0.05 | Finger: 0.08-0.13 / Pass | ||
| Palm: ≥0.05 | Palm: 0.08-0.13 / Pass | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125, 1/124, 0/125, 0/125, 0/125, 0/125 leaks / Pass (Implies a low number of leaks, 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.