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510(k) Data Aggregation
K Number
K212451Device Name
Surgical Mask
Manufacturer
Date Cleared
2021-09-10
(36 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
ReMade USA LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Surgical Face 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 provided nonsterile.
Device Description
The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with a nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.
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