(162 days)
The Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a non - sterile disposable I no religio intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
I am sorry, but the provided text does not contain the information requested regarding acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for a Nitrile Powder-Free Examination Glove, confirming its substantial equivalence to a predicate device. It defines the device's indications for use and general regulatory information but does not include any performance study details or acceptance criteria tables.
§ 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.