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510(k) Data Aggregation
K Number
K202580Device Name
Disposable Surgical Mask
Manufacturer
Date Cleared
2021-06-07
(272 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Qingdao Likangyuan Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
Device Description
The Disposable Surgical Masks (non-sterile) are 3-ply, ear loop, flat-pleated surgical masks. The devices are 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. There surgical masks to be secured on users via ear loops made of spandex and nylon. Each mask contains a nose piece to firmly fit over the nose. The devices are sold non-sterile and are intended to be single use and disposable. This device is not made from any natural rubber latex.
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