Search Results
Found 1 results
510(k) Data Aggregation
K Number
K210063Device Name
Freudenberg Surgical Mask
Manufacturer
Date Cleared
2021-02-05
(25 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Freudenberg Performance Materials LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Freudenberg Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is 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 non-sterile.
Device Description
The Freudenberg Surgical Mask is composed of three-layers and is flat-pleated. The Freudenberg Surgical Mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, melt-blown, white), and inner cover web (polypropylene spunbond, white). Each mask contains polyester spandex blend ear loops to secure the mask over the user's mouth and nose and includes a polyethylene coated wire nosepiece to provide a firm fit over the nose. This face 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