(83 days)
The Medical 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 powder free nitrile examination gloves. The subject device is blue. It can be available in six specifications: S,M,L,XL. The subject device is non-sterile.
The provided text describes the 510(k) summary for the "Medical Nitrile Examination Gloves" (K220066). This document is for a Class I medical device (non-powdered patient examination glove), which is a low-risk device. For such devices, clinical testing is typically not required, and the focus of the submission is on non-clinical performance and substantial equivalence to a predicate device.
Therefore, the requested information regarding AI device performance, sample sizes for test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance does not apply to this specific submission. This document details the testing of physical properties and biocompatibility of examination gloves, not an AI or imaging device.
However, I can extract the acceptance criteria and performance data for the glove product based on the provided non-clinical testing summary.
Here's the relevant information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical, for Medical Nitrile Examination Gloves)
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 - Physical Dimensions Test | |||
| Length (mm) | S: ≥220; M/L/XL: ≥230 | S: ≥220; Pass | |
| M/L/XL: ≥230; Pass | |||
| Width (mm) | S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | S: 83-88 /Pass | |
| M: 93-96/ Pass | |||
| L: 104-109/ Pass | |||
| XL: 110-116/ Pass | |||
| Thickness (mm) | Finger: ≥0.05; Palm: ≥0.05 | Finger: 0.102-0.117/Pass | |
| Palm: 0.068-0.073/Pass | |||
| ASTM D5151 - Watertightness Test | For Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (This implies 0 failures out of 125 samples tested) |
| 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.