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510(k) Data Aggregation
K Number
K211808Device Name
Medcare Powder-Free Blue Nitrile Patient Examination Gloves
Manufacturer
Date Cleared
2022-03-04
(266 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Grinvald Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The powder free patient examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over the counter use.
Device Description
Medcare Powder-Free Blue Nitrile Patient Examination Gloves are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder- free, ambidextrous, and blue-colored with a beaded cuff. The proposed device is offered in the following sizes: S, M, L, XL.
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