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510(k) Data Aggregation
K Number
K203101Device Name
Secure Wear USA Surgical Face Mask
Manufacturer
Date Cleared
2021-03-31
(168 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Secured Ortho Manufacturing of America, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Secure Wear USA™ Surgical Face Mask is intended to be worn to protect both the patient and the healtheare professional from transfer of microorganisms, body fluids, and particulate material. The surgical 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, nonsterile, disposable device.
Device Description
Secure Wear USA™ Surgical Face Mask Product models: Surgical Face Mask, Ear Loop, Level 1: Surgical Face Mask, Ear Loop, Level 2: Surgical Face Mask, Ear Loop, Level 3; Surgical Face Mask, Tie-on, Level 1; Surgical Face Mask, Tie-on, Level 2; Surgical Face Mask, Tie-on, Level 3.
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