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510(k) Data Aggregation
K Number
K212526Device Name
Surgical Face Mask
Manufacturer
Suzhou JaneE Medical Technology Co., Ltd.
Date Cleared
2021-11-09
(90 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Suzhou JaneE Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Medical Surgical 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 Disposable Medical Surgical Masks are green color, three-layer, flat-folded masks with nose piece and ear loops. The green colorant is polypropylene (PP) master batch.
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 ear loops welded to the face mask. The ear loops are not made with natural rubber latex or fiberglass, but nylon and spandex.
The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of Iron core coated with Polyethylene.
The Disposable Medical Surgical Masks are sold non-sterile and are intended to be single use, disposable devices.
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