(70 days)
A 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.
Powder-Free Latex Examination Gloves Polymer Coated with Protein Content Labeling Claim (100 Micrograms or Less)
This document is a 510(k) premarket notification approval letter from the FDA for "Powder-Free Latex Examination Gloves Polymer Trade Name: Coated with Protein Content Labeling Claim (100 Micrograms or Less)."
It does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance, but does not include any performance data, study designs, or ground truth information relevant to the original 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.