(134 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 white. The subject device is non-sterile.
The provided document is a 510(k) summary for a Disposable Nitrile Medical Examination Glove. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. This document is not for an AI/ML medical device, but rather for a physical examination glove. Therefore, many of the requested criteria regarding AI/ML device acceptance, such as expert consensus, MRMC studies, training/test sets, and ground truth establishment, are not applicable to this submission.
However, I can extract and present the acceptance criteria and test results related to the physical and biocompatibility performance of the glove, as described in the document.
Acceptance Criteria and Device Performance for Disposable Nitrile Medical Examination Glove (K210684)
The device, a "Disposable Nitrile Medical Examination Glove," is classified as Class I and its performance is evaluated against established ASTM and ISO standards for medical gloves, rather than complex AI/ML performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria Reported in Document | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): |
- XS/S: ≥220
- M/L/XL: ≥230 | Length:
- XS/S: > 220/Pass
- M/L/XL: > 230/Pass |
| | | Width (mm): - XS: 70±10
- S: 80±10
- M: 95±10
- L: 110±10
- XL: 120±10 | Width:
- XS: 78-80 / Pass
- S: 85-89 /Pass
- M: 95-99/ Pass
- L: 105-111/ Pass
- XL: 115-120/ Pass |
| | | Thickness (mm): - Finger: ≥0.05
- Palm: ≥0.05 | Thickness:
- Finger: 0.09-0.13/Pass
- Palm: 0.07-0.13/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | 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.