(98 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.
SMARTTEX PrePowdered Latex Examination Gloves with Protein claim. (100 MICROGRAM OR LESS) WHITE, BLUE + GREEN
I'm sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for medical gloves and does not contain information about acceptance criteria or a study proving that a device meets such criteria. It primarily discusses the substantial equivalence of the gloves to previously marketed devices and regulatory compliance.
§ 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.