(97 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. During the production process, about 1% ~ 3% nitrile is added to the ingrove the tensile strength and ultimate elongation of the glove. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided text is a 510(k) Summary for a medical device (Disposable Synthetic Vinyl Nitrile Examination Glove). It outlines acceptance criteria and test results for various non-clinical tests. Since the device is not an AI/ML powered device, the questions related to AI/ML powered devices are not applicable.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length(mm): $\ge$ 230; | |
| Width(mm): | |||
| XS: 75 ± 5; | |||
| S: 85 ± 5; | |||
| M: 95 ± 5; | |||
| L: 105 ± 5; | |||
| XL: 115 ± 5; | |||
| Thickness (mm): | |||
| Finger: $\ge$ 0.08 | |||
| Palm: $\ge$ 0.08 | Length: >230/ Pass | ||
| Width: | |||
| XS: 78-80/ Pass | |||
| S: 85-86/Pass | |||
| M: 95-96/Pass | |||
| L: 105-106/Pass | |||
| XL: 115-116/Pass | |||
| Finger Thickness: | |||
| XS: 0.11-0.12/Pass | |||
| S:0.11-0.12/Pass | |||
| M:0.11-0.13/Pass | |||
| L:0.11-0.13/Pass | |||
| XL:0.11-0.13/Pass | |||
| Palm Thickness: | |||
| XS:0.08-0.09/Pass | |||
| S:0.08-0.09/Pass | |||
| M:0.08-0.09/Pass | |||
| L:0.08-0.09/Pass | |||
| XL:0.08-0.09/Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL=2.5 | XS:0/125;S:1/125;M:3/125; L:2/125;XL:2/125 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.