(45 days)
The Powder Free Pink Nitrile Examination Glove, Non-Sterile 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.
The Powder Free Pink Nitrile Examination Gloves, Non Sterile is equivalent to the existing model, i.e. Powder Free Blue Nitrile Examination Gloves, Non Sterile which had submitted and cleared under 510(k) number K022904. The difference in this submission is: Change of colour additive used, i.e. Pink. The modification of colour does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections. The Powder Free Pink Nitrile Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 6319 - 00a23 and FDA 21 CFR 800,20.
This document describes the premarket notification (510(k)) for WRP Asia Pacific Sdn Bhd's Powder Free Pink Nitrile Examination Gloves, Non-Sterile. This is a medical device submission, and the provided text does not contain a study in the context of an AI/ML device or a comparative effectiveness study with human readers. Instead, it details how the modified device (pink gloves) meets established standards for examination gloves.
Therefore, many of the requested elements for an AI/ML device study are not applicable to this submission.
Here's an analysis based on the provided text, addressing the applicable points:
1. A table of acceptance criteria and the reported device performance
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA (Implied) | DEVICE PERFORMANCE |
|---|---|---|---|
| Dimensions | ASTM D 6319 - 00aE3 | Meets ASTM D 6319 - 00aE3 | Meets |
| Physical Properties | ASTM D 6319 - 00aE3 | Meets ASTM D 6319 - 00aE3 | Meets |
| Freedom from pinholes | ASTM D 6319 - 00aE3, FDA 21 CFR 800.20 | Meets ASTM D 6319 - 00aE3, FDA 21 CFR 800.20 (Waterleak AQL) | Meets |
| Powder Residual | ASTM D 6124 - 01 |
§ 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.