(83 days)
A patient examination glove is a disposable device intend for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
BLUE NITRILE EXAMINATION GLOVES, POWDER FREE.
The provided document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria, as it pertains to AI/ML or a more complex medical device. Instead, it confirms that the Nitrile Examination Gloves Powder Free (Blue Color) are substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the given text. The document is primarily an administrative letter about regulatory approval for a low-risk medical device (patient examination gloves).
§ 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.