Search Results
Found 1 results
510(k) Data Aggregation
K Number
K220637Device Name
3 Ply Medical Grade Single Use Procedural Disposable Face Mask
Manufacturer
Date Cleared
2022-03-25
(21 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
KDI Med Supply
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare provider from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluids. This is a single use, disposable device provided non-sterile.
Device Description
The KDI Med Supply surgical face mask is with blue outer color layer and white inner and middle layer. Subject device is a flat pleated type mask, utilizing ear loop way for wearing, and it has a nose piece designed for fitting the face mask around the nose. The mask materials consist of an outer layer (polypropylene spunbond), inner layer (polypropylene spunbond), filter (polypropylene melt-blown) and ear-loops. The masks contains a malleable nose piece to provide a firm fit over the nose and to secure the mask over the users mouth and face. The mask has level II fluid resistance under ASTM F2100. The mask is a single use, provided nonsterile. This product contains no components made with natural rubber latex.
Ask a Question
Ask a specific question about this device
Page 1 of 1