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510(k) Data Aggregation
K Number
K213168Device Name
Medical Examination Gloves
Manufacturer
Date Cleared
2022-01-11
(105 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Shandong Huiwosheng Health Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is a disposable device intended for medical purposes that is worn on hand of the examiner's hand to prevent contamination between the patient and the examiner.
Device Description
The proposed device is a powder free medical glove. The device is blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The difference between each size is just in the dimension. The proposed device is provided non-sterile.
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