Qinhuangdao Taizhi Medical Technology Co., Ltd.

Address:Workshop 5, small and medium-sized enterprise incubation base, East Longgang Road, Haigang District,Qinhuangdao Hebei,CN

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mask, Surgical (FXX) (2)

Premarket Exempt

Clear

CCW - 06973274100520 Catalog Number :

Device Description : The Disposable surgical mask (non sterile) is single use, three-layer, flat-plea The Disposable surgical mask (non sterile) is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users’ mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The Disposable surgical mask (non sterile) will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

Device Class : 2

Duns Number: 715288182

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 1

CCW - 06973274100537 Catalog Number :

Device Description : The mask materials include four layers, the inner and outer layers are made of s The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively.The ear straps are held in place over the users’ mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The mask is a single use, disposable device, provided non-sterile in white color.