(69 days)
a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Textured Powder-Free Latex Examination Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram
This FDA letter is a premarket notification (510(k)) clearance for medical gloves. It does not contain the detailed information about acceptance criteria or specific studies proving device performance that you've requested.
The letter approves the device, indicating that it has been found "substantially equivalent" to legally marketed predicate devices, meaning it meets the same safety and effectiveness standards. However, it does not describe the specific testing or the acceptance criteria used to reach that determination.
Therefore, I cannot provide the information you asked for based on this document. This kind of detail would typically be found in the actual 510(k) submission, not in the clearance letter itself.
§ 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.