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510(k) Data Aggregation
K Number
K201754Device Name
JianYu Surgical Mask
Manufacturer
Date Cleared
2020-12-30
(184 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu JianYu Health Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Jian Yu surgical mask is intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The JianYu surgical mask is a single use, disposable device provided non-sterile.
Device Description
The JianYu surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (spunbond polypropylene, blue), filter layer (meltblown polypropylene, white), and inner layer (spunbond polypropylene, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical mask is a single use, disposable device, provided non-sterile.
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