(45 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Latex Examination Gloves with protein labeling claim less than of 50 microgram or less of total water extractable protein per gram of gloves. with creamy (white) and blue colors.
I am sorry. I cannot provide the answer based on the context. The document is about a 510(k) premarket notification for examination gloves, which does not contain information about acceptance criteria and study data for a medical device's performance.
§ 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.