(20 days)
The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Green Chlorinated Powder Free Latex Examination Gloves With Protein Content Labeling Claim of 50 micrograms or less.
The provided text is a letter from the FDA to Hartalega Sdn. Bhd. regarding the substantial equivalence of their "Green Chlorinated Powder Free Latex Examination Gloves (With Protein Labeling Claim)". It does not contain information about the acceptance criteria and study details as requested. It is a regulatory approval document and not a scientific study report. Therefore, I cannot extract the requested information from this document.
§ 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.