(83 days)
A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.
Latex Examination Powder Free with proteins content label claim 50 MICROGRAMS OR LESS
This document is a 510(k) clearance letter from the FDA for "Innovative Gloves Latex Examination Gloves Trade Name: Powderfree With Protein Labeling Claim [50 Micrograms or Less]". It addresses the substantial equivalence of the device but does not contain acceptance criteria for performance, a study to prove acceptance criteria, or information on sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices.
§ 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.