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510(k) Data Aggregation
K Number
K212264Device Name
Surgical Face mask
Manufacturer
Nantong Taiweishi Medical Technology Co., Ltd.
Date Cleared
2021-11-13
(116 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Nantong Taiweishi Medical Technology 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. These face masks are 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 sterile.
Device Description
The Surgical Face Masks are single use, three-layer, flat –folded masks with ear loops and nose clamp. 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 ear loops welded to the facemask. The loops are made of Nylon and spandex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Polypropylene. The Surgical Face Masks will be provided in blue. The Surgical Face Masks are sold sterilized and are intended to be single use, disposable devices.
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K Number
K203426Device Name
Surgical Face Mask (non-sterile)
Manufacturer
Nantong Taiweishi Medical Technology Co., Ltd.
Date Cleared
2021-02-18
(90 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Nantong Taiweishi Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Face Mask (non-sterile) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
Device Description
The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose.
The proposed device(s) 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 model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of nylon and spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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