(283 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands of fingers to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove. 80LZA, and meets all requirement of ASTM Standard D6319-10.
This document describes the premarket notification for the "Blue Nitrile Powder-Free Exam Glove" by Shandong Xinshi Medical Products Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Predicate Device Requirement | Device Performance (Blue Nitrile Powder-Free Exam Glove) |
|---|---|---|
| Mechanical Properties | ||
| Before Aging: Tensile Strength (Mpa) | Substantially equivalent | Average 28.77 Mpa |
| Before Aging: Ultimate Elongations (%) | Substantially equivalent | Average 759.23% |
| After Aging: Tensile Strength (Mpa) | Substantially equivalent | Average 24.00 Mpa |
| After Aging: Ultimate Elongations (%) | Substantially equivalent | Average 712.31% |
| Physical Dimensions | ||
| Overall Length on Medium Size | Substantially equivalent | Average 231 mm |
| Width of Palm on Medium Size | Substantially equivalent | Average 95.15 mm |
| Palm Thickness | Substantially equivalent | Average 0.08 mm |
| Finger Thickness | Substantially equivalent | Average 0.09 mm |
| Barrier Integrity | ||
| Free of Pinhole | Meets ASTM D5151-06 (AQL 2.5) | Testing result indicates pinhole were found less than two pieces gloves out of 125 pieces gloves. AQL 2.5 is met. |
| Material/Processing Residuals | ||
| Residue Powder | Meets ASTM 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.