(33 days)
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient." [50 Microgram or less Protein labeling Claim]
Polymer Coated Powder Free Latex Examination Gloves
This document is a 510(k) premarket notification letter from the FDA regarding "Latex Examination Gloves (50 mcg or less protein labeling claim)". It concerns the regulatory approval of a medical device, which is a type of glove, and does not involve AI or an algorithm. Therefore, none of the requested information about AI device acceptance criteria, study data, ground truth, or MRMC studies is applicable to this document.
The document primarily states that the device is substantially equivalent to legally marketed devices and can be marketed subject to general controls. It details the product name, applicant, 510(k) number, and indications for use, which are as follows:
Indications For Use: "A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient." with a "[50 Microgram or less Protein labeling Claim]".
The document does not contain information on device performance metrics, study designs, sample sizes, or expert qualifications as it is a regulatory approval letter based on substantial equivalence, not a performance study report for an AI device.
§ 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.