(272 days)
The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
"Disposable Powder Free Nitrile Examination Glove, Pink Color" and "Disposable Powder Free Nitrile Examination Glove, Black Color" are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
This document is a 510(k) summary for a disposable powder-free nitrile examination glove, and as such, it focuses on demonstrating substantial equivalence to a predicate device based on bench testing. It does not describe an AI medical device, and therefore, many of the requested elements for AI/ML evaluation (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance of an algorithm) are not applicable.
However, I can extract the acceptance criteria and reported device performance from the provided text for the physical characteristics of the glove.
1. Table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM D6319-10 (Reapproved 2015) | |
| Length | ≥230mm | Complies with ASTM D6319-10 (230mm min.) |
| Width (X-Small) | 70 ± 10 mm | Complies with ASTM D6319-10 (70 ± 10 mm) |
| Width (Small) | 80 ± 10 mm | Complies with ASTM D6319-10 (80 ± 10 mm) |
| Width (Medium) | 95 ± 10 mm | Complies with ASTM D6319-10 (95 ± 10 mm) |
| Width (Large) | 110 ± 10 mm | Complies with ASTM D6319-10 (110 ± 10 mm) |
| Width (X-Large) | 120 ± 10 mm | Complies with ASTM D6319-10 (120 ± 10 mm) |
| Thickness (Finger tip) | ≥0.05mm | Complies with ASTM D6319-10 (0.05mm min.) |
| Thickness (Palm) | ≥0.05mm | Complies with ASTM D6319-10 (0.05mm min.) |
| Physical Properties | ASTM D6319-10 (Reapproved 2015) | |
| Tensile strength (Before aging) | ≥14MPa | 14 MPa, min. |
| Tensile strength (After aging) | ≥14MPa | 14 MPa, min. |
| Elongated rate (Before aging) | ≥500% | 500% min. |
| Elongated rate (After aging) | ≥400% | 400% min. |
| Freedom from pinholes | Passed Standard Acceptance Criteria (21 CFR 800.20, ASTM D6319-10, ASTM D5151-06) | In accordance with ASTM D6319-10 and ASTM D5151-06, G-1, AQL 2.5 |
| 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.