A QuicOver Zeolite Hemostatic Gauze in its packaging, a white gauze pad, and a tray showing the empty packaging.

FDA

Official letter from the U.S. Food and Drug Administration dated April 21, 2023, addressed to Hangzhou Zeo-Innov Life Technology Co., Ltd., signed by Julie A. Morabito-S, regarding an update on a medical device called Zeolite Hemostatic Gauze, with contact information and FDA logo at the top.
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Package of QuicCover Zeolite Dressing for emergency external use

Surgical & Emergency Zeolite Hemostatic Gauze

Dimensions

Size per piece - 9cm x 10cm, 1or 2 pieces per sterile pack.

This is a disposable product.

This product is used for surgical wound surfaces, burns, gunshot wounds, and hemostasis and protection of soft tissue. It is suitable for hospital operating rooms, emergency rescue sites and battlefield first aid (301 hospital zeolite combat gauze comparison study) (Human trial 38, field test).

No burning, no adverse.

Effective for massive bleeding control.

No cytotoxicity; no delayed hypersensitivity, no acute systemic toxicity, no hemolysis or pyrogen.

Composition Gauze

Zeolite crystalline

Effective time 3 years

Indication for Use

Prescription Use: Zeolite Hemostatic Gauze is intended for temporary external use to control traumatic bleeding.

Over-The-Counter Use: Zeolite Hemostatic Gauze is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.

Device Description: The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is provided in a sterile dressing format that conforms readily to the wound. It is available in four types, which are P (Sheet), J (Rolled), Z (Folded) and L (Cubed). The difference between each type is the dressing shape. Each type is available in a range of different sizes.

Product Details
Product label for Zeolite Hemostatic Gauze, containing instructions, manufacturer information, storage conditions, and symbols indicating sterile and non-reusable use.
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