(106 days)
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. The device is single use only.
The Pearlescent Black Textured Powder- Free Latex Examination Gloves, Coated with Aloe Vera at pH 5.0-5.5, with (Protein Content Labeling Claim) Contains 50 micrograms or less of Total Water Extractable Protein per gram which had been submitted and cleared under 510(k) number K013793. The difference in this submission is: a) Change of color to be Pearlescent Black.
The provided document describes the acceptance criteria and performance of "Pearlescent Black Textured Powder-Free Latex Examination Gloves, Coated with Aloe Vera at pH 5.0-5.5, with Protein Content Labeling Claim". This is a medical device (examination glove) and the testing performed is for product specifications and biocompatibility, not for a diagnostic AI algorithm. Therefore, many of the requested categories (sample size for test/training sets, experts for ground truth, adjudication, MRMC studies, standalone performance, data provenance) are not applicable in this context.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (Standards) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-05e1 | Meets |
| Physical Properties | ASTM D 3578-05e1 | Meets |
| Freedom from pinholes | ASTM D 5151-99 (AQL) | Meets (AQL 2.5) |
| Powder Residual | ASTM D 6124-06 | Meets ( |
§ 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.