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510(k) Data Aggregation
K Number
K050689Device Name
SURGICAL FACE MASK
Manufacturer
Date Cleared
2005-10-26
(223 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
CHINA SURGICAL DRESSINGS CENTER CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgical masks/Procedure Mask is a high 3 ply face mask is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.
Device Description
The Surgical Face Mask is a flat, pleated tie-on or elastic ear-loop mask consisting of 3-ply Non-Woven material; inner and outer cover web with middle different filter web sandwiched in between. It covers the nose and mouth of the wearer, and is held in place by tie string or elastic ear loop and a malleable plastic coated wire nose piece. For protection against airborne particles and splatters of blood and saliva…etc
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