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510(k) Data Aggregation
K Number
K171047Device Name
Sterile Polyisoprene Powder Free Surgical Gloves
Manufacturer
Date Cleared
2017-06-22
(76 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Better Care Plastic Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This surgeon's glove is a sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
Device Description
The subject device is single-use disposable powder-free surgical glove that is supplied sterile and made of polyisoprene.
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