(160 days)
A 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 This glove contains 50 micrograms or less of total water extractable Protein per gram.
Powder-Free Patient Examination Glove
This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)." It does not describe:
- Acceptance criteria and reported device performance: The letter states the device is "substantially equivalent" to legally marketed predicate devices, but it does not provide specific acceptance criteria or performance data for the device itself. The protein labeling claim "50 micrograms or less of total water extractable Protein per gram" is an indication for use, not an acceptance criterion with associated test results.
- Study details for general performance: This document is a regulatory approval, not a scientific study report. It does not contain information about sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. This letter confirms that the device has met the FDA's regulatory requirements for substantial equivalence, which typically means it performs similarly to predicate devices already on the market. The specific testing and data used to establish that equivalence would be in the detailed 510(k) submission, not in this clearance letter.
§ 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.