(34 days)
A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I latex patient examination glove, 80LYY, powder free And meeting all the requirements of ASTM D-3578-01aE2, Standard Specification for Latex Examination Gloves for Medical Application.
The provided document does not describe an AI medical device. It pertains to a **Non-Sterile Powder-Free Green Latex Examination Gloves with or without Sour Apple or Peppermint Scenting Plus a 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.