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510(k) Data Aggregation
K Number
K172500Device Name
Technoweb Surgical Mask
Manufacturer
Date Cleared
2018-03-01
(195 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
YTS GLOBAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Technoweb Sugical Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Device Description
Technoweb Surgical Mask is a type of surgical mask covers the user's nose and mouth. And provides a physical barrier to fluids and particulate materials. Technoweb Surgical Mask is a flat, pleated tie-on or elastic ear-loop mask consisting of three nonwoven layers; inner and outer cover web with middle different filter web sandwiched in between.
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