(21 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.
PRE-POWDERED NON-STERILE. VINYL EXAMINATION GLOVES
The provided text is a 510(k) clearance letter from the FDA to Shanqhai Champion Plastic Products Co., Ltd. for pre-powdered vinyl examination gloves. It is a regulatory document and does not contain information about the acceptance criteria or a study proving the device meets those criteria. Such studies and criteria are typically found in the 510(k) submission itself, of which this letter is only the clearance response.
Therefore, I cannot provide the requested information based on the given input. The document focuses on regulatory approval based on "substantial equivalence" to a predicate device, rather than detailed performance study results against specific acceptance criteria.
§ 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.