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510(k) Data Aggregation
K Number
K211520Device Name
Amerishield Surgical Mask
Manufacturer
Date Cleared
2021-06-15
(29 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
PremiumEStore, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This mask is intended to be worn to protect both the patient and healthcare personnel fromtransfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
Device Description
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K Number
K211275Device Name
AirMax Procedure Mask
Manufacturer
Date Cleared
2021-05-25
(28 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
PremiumEStore, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This mask is intended to be worn to protect both the patient and healthcare personnel fromtransfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
Device Description
Not Found
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Ask a specific question about this device
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