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510(k) Data Aggregation
K Number
K212699Device Name
Disposable Powder Free Polyethylene Examination Gloves
Manufacturer
Date Cleared
2022-05-31
(279 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Mastermax Plastic (Huizhou) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Disposable Powder Free Polyethylene Examination Gloves are powder free and non-sterile disposable devices intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
The Disposable Powder Free Polyethylene Examination Gloves are non-sterile disposable patient examination glove. The gloves are made of translucent (clear), low density polyethylene material and are powder free. The Disposable Powder Free Polyethylene Examination Gloves come in four sizes: Small, Medium, Large, X Large. The Disposable Powder Free Polyethylene Examination Gloves act as a barrier to prevent contamination between patient and examiner. The physical and performance characteristics of the device meets all requirements of ASTM D5250 and ASTM D5151.
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