(90 days)
APOLLO ADVANTAGE Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
APOLLO ADVANTAGE Nitrile Examination Gloves are made of Nitrile rubber and are blue in color. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151 and ASTM D6319. The proposed device is non-sterile and powder free.
This document is primarily concerned with the 510(k) premarket notification for APOLLO ADVANTAGE Nitrile Examination Gloves, asserting its substantial equivalence to a predicate device. It details acceptance criteria and performance data for various physical and biocompatibility characteristics of the gloves.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): | Length (mm): |
| S: ≥220 | S: 221-238mm | ||
| M/L/XL: ≥230 | M: 232-251mm; L: 232-243mm; XL: 234-250mm | ||
| Width (mm): | Width (mm): | ||
| S: 80 ± 10 | S: 80-89mm | ||
| M: 95 ± 10 | M: 94-104mm | ||
| L: 110 ± 10 | L: 102-111mm | ||
| XL: 120 ± 10 | XL: 111-122mm | ||
| Thickness (mm): | Thickness (mm): | ||
| Finger: ≥0.05 | Finger: S: 0.11-0.15mm; M: 0.11-0.15mm; L: 0.11-0.14mm; XL: 0.11-0.16mm | ||
| Palm: ≥0.05 | Palm: S: 0.08mm; M: 0.08mm; L: 0.08mm; XL: 0.08mm | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 (Acceptable Quality Limit) | 0 glove water leakage found |
| 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.