(54 days)
The NITRILE EXAMINATION GLOVES is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is white, cobalt blue, black, blue. It can be available in six specifications: S, M, L, XL. The subject device is non-sterile.
This document is a 510(k) Premarket Notification for Nitrile Examination Gloves, a Class I medical device. The information provided is specifically for proving the substantial equivalence of these gloves to a legally marketed predicate device.
Therefore, the request for acceptance criteria and study details related to AI/ML-based medical devices using concepts like "human readers improve with AI vs without AI assistance," "standalone algorithm performance," "number of experts," "adjudication method," and "training set size and ground truth" are not applicable to this document.
This document describes the performance of the physical glove itself, not a software algorithm.
Here's a breakdown of the requested information based on the provided document, highlighting why most of the AI/ML-related questions are irrelevant:
1. A table of acceptance criteria and the reported device performance
The document provides this information clearly in "Table 2 - Summary of non-clinical performance testing" on pages 6-9.
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): |
- S: ≥ 220
- M/L/XL: ≥ 230
Width (mm): - S: 80 ± 10
- M: 95 ± 10
- L: 110 ± 10
- XL: 120 ± 10 | Length (mm):
- S: ≥ 220
- M/L/XL: ≥ 230.
Width (mm): - White: S: 85-88/Pass, M: 96-98/Pass, L: 106-108/Pass, XL: 114-117/Pass
- Cobalt Blue: S: 83-86/Pass, M: 95-99/Pass, L: 105-109/Pass, XL: 113-117/Pass
- Black: S: 85-87/Pass, M: 95-98/Pass, L: 104-107/Pass, XL: 114-117/Pass
- Blue: S: 84-86/Pass, M: 96-102/Pass, L: 104-107/Pass, XL: 114-116/Pass
Thickness (mm): - Finger: White: 0.07-0.11/Pass, Cobalt Blue: 0.10-0.14/Pass, Black: 0.14-0.16/Pass, Blue: 0.09-0.11/Pass
- Palm: White: 0.05-0.07/Pass, Cobalt Blue: 0.08-0.10/Pass, Black: 0.11-0.13/Pass, Blue: 0.07-0.08/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 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.