(140 days)
Textured Powder-Free Latex Exam Gloves, with Aloe Vera and Protein Claim is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.
Textured Powder-Free Latex Exam Gloves, with Aloe Vera and Protein Claim
This document is a 510(k) premarket notification letter from the FDA to Shen Wei (USA), Incorporated, regarding their Textured Powder-Free Latex Examination Gloves with Aloe Vera and Protein Content Labeling claim. It is not a study report for a medical device that uses AI or reports on performance metrics that would typically apply to software or diagnostic devices.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, and MRMC studies is not applicable to this document. This document is related to traditional medical gloves, which are physical devices and do not involve AI or complex diagnostic performance evaluation as described in your request.
§ 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.