Helmet, Surgical

Who Makes This Device Type in China?

7 manufacturers in China hold an FDA registration for this device type, concentrated in Hubei, Guangdong and Fujian, and 1 other province. 2 of them are contract manufacturers, able to build to a buyer’s own specification.

Fofo Medical Co., Ltd. Fujian
Foshan Hongfeng Co., Ltd. Guangdong, contract manufacturer
Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
Henan Joinkona Medical Products Stock Co., Ltd. Henan, contract manufacturer
Hubei Lioncare Protective Products Co., Ltd. Hubei
Xianning Full Guard Medical Products Co., Ltd. Hubei
Xiantao Daoqi Plastic Co., Ltd. Hubei, contract manufacturer

What Is FDA Product Code FXZ?

Helmet, Surgical is FDA product code FXZ, Class 1, 21 CFR 878.4040.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Helmet, Surgical

ViVi® HELMET25 XL

Catalogue number 81100XL, listed by THI Total Healthcare Innovation Gmbh, Austria, under Helmet, Surgical. 7 manufacturers in China are registered for this product code.

Helmet, Surgical

ViVi® HELMET25

Catalogue number 81100, listed by THI Total Healthcare Innovation Gmbh, Austria, under Helmet, Surgical. 7 manufacturers in China are registered for this product code.

Helmet, Surgical

ViVi® HELMET25 HPL

Catalogue number 81130, listed by THI Total Healthcare Innovation Gmbh, Austria, under Helmet, Surgical. 7 manufacturers in China are registered for this product code.

Helmet, Surgical

Maxair

Capr IR Helmet

Helmet, Surgical

ViVi® HELMET25 XL HPL

Catalogue number 81130XL, listed by THI Total Healthcare Innovation Gmbh, Austria, under Helmet, Surgical. 7 manufacturers in China are registered for this product code.

Helmet, Surgical