(232 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color 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.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Patient Examination Gloves. It details the device's characteristics and compares them to a predicate device to establish substantial equivalence.
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The device's performance is compared against established standards, primarily ASTM D6319-10 (Reapproved 2015) for Nitrile Examination Gloves for Medical Application, along with other ISO and ASTM standards for biocompatibility and specific tests.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D 6319-06 (Reapproved 2015) | Dimension | ||
| - Length | ≥230mm min | 232 mm min for all sizes (Similar to predicate) | |
| - Width | Small: 70-90 mm | ||
| Medium: 85-105mm | |||
| Large: 100-120mm | |||
| X large: 110-130 mm | Small: 75-90 mm | ||
| Medium: 88-102 mm | |||
| Large: 107-117mm | |||
| X large: 114-128 mm (Similar to predicate) | |||
| - Thickness | Fingertip: ≥0.05mm min. | ||
| Palm: ≥0.05mm min. | Fingertip: ≥0.08mm | ||
| Palm: ≥0.08mm (Similar to predicate) | |||
| ASTM D 6319-06 (Reapproved 2015) | Physical Properties | ||
| - Tensile strength (Before & After aging) | ≥ 14MPa | 17-24 (Before Aging), 17-22 (After Aging) (Similar to predicate) | |
| - Before aging Elongation | ≥500% | 540-610 (Similar to predicate) | |
| - After aging Elongation | ≥400% | 460-570 (Similar to predicate) | |
| 21 CFR 800.20 | |||
| ASTM D 6319-06 (Reapproved 2015) | |||
| ASTM D5151-19 | Freedom from pinholes | Water leakage test: Inspection Level I, AQL 2.5, and Accept/Reject criteria of 10/11. | 5 noncompliance is allowed (Similar to predicate) |
| ASTM D6319-10 (Reapproved 2015) | |||
| ASTM D6124-06 (Reapproved 2017) | Powder Residual |
§ 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.