(115 days)
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of 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.
Latex Powder Free Polymer Coated Examination Gloves with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
I am sorry but this document does not contain the information you are looking for. None of the information you are requesting, such as acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment, is available in the provided text. The document is a 510(k) premarket notification letter from the FDA regarding a medical device, specifically "Latex Powder Free Polymer Coated Examination Gloye with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove." It confirms substantial equivalence to predicate devices and outlines regulatory requirements.
§ 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.