(93 days)
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nittile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU) is a non sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nittile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA regarding several types of Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant. These are patient examination gloves, a Class I device.
The document does not contain information about acceptance criteria or a study proving the device meets those criteria, as requested in the prompt. The text focuses on the regulatory determination of substantial equivalence to predicate devices and general controls provisions of the Act. It includes the indications for use for four different colored gloves in separate "Indications for Use" forms.
Therefore, I cannot provide the requested information from this document.
§ 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.