Foshan GoodFeeling Hygiene Material Tec Co., Ltd.

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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

Face Mask Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health Emergency (QKR) (1) Mask, Surgical (FXX) (1)

Premarket Exempt

No Yes

Clear

GoodFeeling Disposable Medical Face Mask (non-sterile) - 06973078400161 Catalog Number :

Device Class :

Duns Number: 551102789

Premarket Exempt : Yes

Product Code : QKR

Prescription Use : No

Device Count : 50

GoodFeeling Medical Surgical Mask (non-sterile) - 06973078400208 Catalog Number :

Device Description : The medical surgical masks are intended to be worn to protect both the patient a The 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. These 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 non-sterile.

Device Class : 2

Duns Number: 551102789

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

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