(330 days)
The mCare Powder Free Latex Examination Blue 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.
mCare Powder Free Latex Examination Blue Glove
This document is a 510(k) premarket notification decision letter from the FDA for a patient examination glove. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.
The document confirms that Mercator Medical (Thailand) Ltd.'s "mCare Powder Free Latex Examination Blue Glove" is substantially equivalent to legally marketed predicate devices. It discusses general regulatory requirements for medical devices but provides no performance data or study details for this specific product.
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.