(124 days)
Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05
This document pertains to the 510(k) premarket notification for "Nitrile Powder Free Patient Examination Gloves, Coloured (Blue)" submitted by Tangshan Xiangrui Plastic Products Co., Ltd. The product is a disposable, non-sterile glove intended for medical purposes to prevent cross-contamination.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is assessed against established industry standards and FDA regulations for patient examination gloves.
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 6139-05 | Meets |
| Physical Properties | ASTM standard D 6139-05 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-06 |
§ 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.