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510(k) Data Aggregation
K Number
K202069Device Name
BASE4 Disposable Medical Mask
Manufacturer
Base4 Group, Inc.
Date Cleared
2020-12-01
(127 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Base4 Group, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
Device Description
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops and a nose piece. The outer and inner layers are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. Each mask is secured to the face with ear loops with a nosepiece to conform the mask to the shape of the nose.
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