(24 days)
A powder-free medical glove made from synthetic nitrile latex is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluid, waste, or environment.
POWDER-FREE NITRILE EXAMINATION GLOVES
I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets any specific criteria. The document is a 510(k) clearance letter from the FDA for "Powder-Free Nitrile Examination Gloves."
This letter indicates that the device is substantially equivalent to legally marketed predicate devices, which allows it to be marketed. However, it does not detail specific performance metrics, acceptance criteria, or a study that directly demonstrates the device meets such criteria. Instead, it mentions general controls provisions and compliance with Good Manufacturing Practice (GMP) requirements.
Therefore, I cannot extract the information required to populate the table and answer your questions regarding acceptance criteria and study details.
§ 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.