Search Results
Found 1 results
510(k) Data Aggregation
K Number
K202214Device Name
IFM Surgical Mask Model SM3
Manufacturer
Date Cleared
2021-03-02
(208 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
FSSC, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IFM Surgical Mask Model SM3 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 single use, disposable device, provided non-sterile.
Device Description
The IFM Surgical Mask Model SM3 is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, melt-blown, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene melt-spunbond, white). Each mask contains ear loops to secure the mask over the user's mouth and nose and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
This device is not made with natural rubber latex.
Ask a Question
Ask a specific question about this device
Page 1 of 1