(259 days)
a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.
Textured Powder-Free Latex Examination Gloves with Protein Labeling Claim (contains 50 micrograms or less of total water extractable protein per gram), Blue Color
This document is a 510(k) premarket notification letter from the FDA regarding a medical device, specifically Textured Powder-Free Latex Examination Gloves. It is not a study report or clinical trial documentation, and therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The letter primarily:
- Acknowledges the review of the 510(k) submission (K030583).
- States that the device is substantially equivalent to legally marketed predicate devices.
- Grants permission to market the device, subject to general controls.
- Provides information on regulatory compliance.
The second attachment to the letter, titled "INDICATION FOR USE," describes the intended use of the gloves but does not present any performance data or acceptance criteria for evaluation.
§ 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.