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510(k) Data Aggregation
K Number
K212944Device Name
Disposable Surgical Mask
Manufacturer
Date Cleared
2021-12-15
(93 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Heilongjiang Yinjia Medical Equipment 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. The Disposable Surgical 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(s), provided non-sterile.
Device Description
Disposable Surgical Mask, Ear Loop Type, Size M and S is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which 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 face mask. The latex free elastic ear loops are made of polyamide fibers and spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of core iron wire with halogen-free polyethylene covering. The Disposable Surgical Mask will be provided in blue of outside and white of inside. The Disposable Surgical Mask is provided non-sterile and for single use.
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