(329 days)
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
I am sorry, but this document contains no information regarding acceptance criteria or a study proving device performance for the "Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green" (K202085).
The document is an FDA 510(k) clearance letter, which indicates that the device has been found substantially equivalent to a legally marketed predicate device. It defines the device, its regulation, and general controls, but does not include details on performance studies or acceptance criteria beyond indicating its intended use as a medical examination glove.
§ 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.