(41 days)
The 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.
The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 -- 01a"22 and FDA 21.CFR 800.20.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less)":
It's important to note that this 510(k) summary is for a medical device (gloves), not an AI algorithm. Therefore, many of the typical questions related to AI studies (like sample size for test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, or training set details) are not applicable or not provided in this type of submission.
The document primarily focuses on demonstrating that the gloves meet established industry standards and regulatory requirements.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard / Acceptance Criteria Location | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 01aE2 | Meets |
| Physical Properties | ASTM D 3578 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01aE2 & FDA 21 CFR 800.20 | Meets (implicitly, as it states it meets standards and FDA requirements for water leak test on pinhole AQL) |
| Powder-Free | 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.