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510(k) Data Aggregation
K Number
K210304Device Name
Surgical Mask
Manufacturer
Date Cleared
2021-05-04
(90 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Jin Pin Electrical CO., LTD. Zhuhai S.E.Z.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Device Description
Surgical Mask (Model KZ-D31)
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