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510(k) Data Aggregation
K Number
K211177Device Name
Powder Free Vinyl Patient Examination Gloves
Date Cleared
2021-07-17
(88 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free Vinyl Patient Examination Gloves Are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application.
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