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510(k) Data Aggregation
K Number
K201625Device Name
Disposable Medical Surgical Mask
Manufacturer
Date Cleared
2021-01-12
(211 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Tianjin Saiyuan Technology CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Medical Surgical Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, blood, body fluids and particulate material. This surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
Device Description
The Disposable Medical Surgical Mask (rectangular) is single use, three-layer, flat-folded masks with ear loops and nose piece. The Surgical Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The mask is held in place by the elastic ear loops. The nose piece in the layers of surgical mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire. The mask is a single use, disposable device, provided non-sterile. This device is not made from Natural Rubber Latex.
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