(395 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.
Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-01ar2 Standard Specification for Latex Examination Gloves for Medical' Application.
The document provided is a 510(k) Premarket Notification from the FDA for a medical device: "Non-Sterile Powder Free Green Latex Patient Examination Gloves with Nopal/Aloe Vera/Vitamin E and Donning Aid Coating, and With Protein Labeling Claim (
§ 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.