(67 days)
With Protein Content Labeling Claim (100 micrograms or less of total water extractable Protein per gram). A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
BLOSSOM™ Powdered Latex Examination Gloves
The provided text is a 510(k) clearance letter from the FDA for "Blossom™ Powdered Latex Examination Gloves with Protein Content Labeling Claim (100 micrograms or less)." This document does not contain information about acceptance criteria, device performance, study details, or ground truth establishment related to a study proving the device meets acceptance criteria.
The letter is primarily a regulatory communication stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It confirms that the device can be marketed subject to general controls provisions.
Therefore, I cannot provide the requested information based on the input text. The questions posed are typically answered in a detailed study report or a 510(k) summary (which is generally distinct from the clearance letter itself) that would describe the testing performed to support the protein content claim.
§ 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.