(112 days)
The Nitrile Examination Glove 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 a single use, powder free nitrile examination glove. The subject device is black. It can be available in four specifications: S,M,L,XL. The subject device is non-sterile, ambidextrous.
The provided document is a 510(k) Premarket Notification for Nitrile Examination Gloves (K213843). This submission is for a medical device (gloves), not an AI/Software device. Therefore, the questions related to AI/Software performance, such as MRMC studies, ground truth establishment for training sets, and expert adjudication, are not applicable.
The document assesses the substantial equivalence of the Nitrile Examination Gloves to a predicate device (K171422) based on non-clinical performance testing.
Here's the information extracted from the document concerning the acceptance criteria and study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides a "Summary of non-clinical performance testing" in Table 2 (pages 6-7), comparing acceptance criteria with test results.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S: ≥220; M/L/XL: ≥230 | Length (mm): S: ≥220; Pass |
| M/L/XL: ≥230; Pass | |||
| Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | Width (mm): S: 83-88 /Pass; M: 95-97/ Pass; L: 106-109/ Pass; XL:111-116/ Pass | ||
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Thickness (mm): Finger: 0.16-0.18/Pass; Palm: 0.12-0.14/Pass | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | S: 0/125/Pass; M: 0/125/Pass; L: 0/125/Pass; XL: 0/125/Pass* |
| *Note: The numerical result (e.g., 0/125) likely indicates 0 failures out of 125 samples tested, meeting the AQL of 2.5 (meaning acceptance on a 125 sample with 0 defects). | |||
| 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.