(213 days)
Powder-Free Nitrile Examination Glove Flock-Lined, Black Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color Non-Sterile, is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. The gloves are lined with cotton flock, ambidextrous with beaded cuff, black colored, single use disposable devices that comes is six sizes (XS, S, M, L, and XL) supplied in non-sterile state. The gloves are made of synthetic rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical and performance characteristics meet all requirements of ASTM D6319-10. Powder was not used for this glove's manufacturing process.
This document describes a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves Flock-Lined, Black Color." The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties (Before/After Aging) | ASTM D6319-10 | Meets |
| Freedom from pinholes | ASTM D6319-10 / ASTM D5151-11 | Meets |
| Powder Residual | ASTM D6319-10 | Meets |
§ 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.