(14 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color." This document does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter primarily:
- Confirms the FDA has reviewed the 510(k) submission (K022087).
- Determines the device is substantially equivalent to legally marketed predicate devices.
- Explains the regulatory classification and general controls provisions of the Federal Food, Drug, and Cosmetic Act.
- Grants permission to market the device.
- Provides contact information for further questions.
The "Indications For Use" statement describes the intended purpose of the gloves, but it does not specify performance acceptance criteria or details of a study.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.