(33 days)
The Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove is in black color, non-sterile and can be available in six specifications: XS, S, M, L, XL, XXL. It meets all of the requirements of ASTM standard D6319-19.
The provided document is a 510(k) Premarket Notification from the FDA for "Disposable Medical Examination Nitrile Gloves." It details the device's characteristics, intended use, and comparison to a predicate device, along with non-clinical testing results.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Test | Length (mm): XS/S: ≥220; M/L/XL/XXL: ≥230 | Length(mm): Pass; XS/S: ≥220; Pass; M/L/XL: ≥230; |
| Width (mm): XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Width(mm): Pass; XS: 74-77mm; S: 83-87mm; M: 96-98mm; L: 103-107mm; XL: 112-115mm; XXL: 120-123mm; | ||
| Thickness (mm): Finger: >0.05; Palm: >0.05 | Thickness (mm): Finger: 0.123-0.182/Pass; Palm: 0.112-0.140/Pass | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | 0/125/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.