(76 days)
a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.
Textured Powder-Free Latex Examination Gloves with Protein Claim ( Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram), Green Color
This document is a 510(k) premarket notification letter from the FDA regarding a medical device, specifically "Textured Powder-Free Latex Examination Gloves with Protein Claim". It primarily addresses the device's substantial equivalence to a predicate device and its regulatory classification.
The letter does not contain any information about the acceptance criteria or a study proving the device meets acceptance criteria. It mentions protein claims (containing 50 micrograms or less of total water extractable protein per gram) but it doesn't describe the testing or study conducted to verify this claim.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.