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510(k) Data Aggregation
K Number
K222749Device Name
High Fluid-Resistant Surgical and Procedure Mask
Manufacturer
Date Cleared
2022-11-14
(63 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Americas Supply Chains
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The High Fluid-Resistant Surgical and Procedure Mask is 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 potential exposure to blood and body fluids. The face mask is a single use, disposable device, provided non-sterile.
Device Description
The High Fluid-Resistant Surgical and Procedure Mask is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose. This device is not made from natural rubber latex.
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