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510(k) Data Aggregation
K Number
K211899Device Name
Surgical Face Mask
Manufacturer
Hubei YI-YA PROTECTIVE PRODUCTS CO., LTD
Date Cleared
2021-10-04
(105 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Hubei YI-YA PROTECTIVE PRODUCTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Device Description
The Surgical Face Masks are blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron bar coated with Polyolefin. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices. The proposed device will be provided in two models of level 3. The two models are totally the same, only distinguished by level 2 & level 3 for business purpose.
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