(63 days)
A patient examination glove is a disposable device intended for medical purpose and similiar personnel to prevent contamination between health care personnel and the patient.
Latex examination gloves (with a protein label claim), Peccaler of Contamp 170 mili grams on less
This document is a 510(k) clearance letter from the FDA for "Quality Latex Powdered Examination Gloves with Protein Labeling Claim of 170 micrograms or less." It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is specifically about the regulatory approval of a medical glove.
Therefore, I cannot provide the requested information.
§ 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.