He Chuang Plastic & Rubber Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What He Chuang Plastic & Rubber Co., Ltd. makes
He Chuang Plastic & Rubber Co., Ltd. manufactures powder-free nitrile examination gloves in blue, specifically tested for use with chemotherapy drugs. These gloves are designed for medical examinations and procedures requiring chemical resistance.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway in the United States. The manufacturer is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA establishments
- He Chuang Plastic & Rubber Co., Ltd Zibo Shandong · CN FEI 3015335977
Frequently asked questions
How many devices does He Chuang Plastic & Rubber Co., Ltd. have in the registry?
The registry currently lists 1 device for He Chuang Plastic & Rubber Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list He Chuang Plastic & Rubber Co., Ltd.'s devices?
Among its 1 most recently registered device, He Chuang Plastic & Rubber Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do He Chuang Plastic & Rubber Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for He Chuang Plastic & Rubber Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from He Chuang Plastic & Rubber Co., Ltd. in the registry?
The most recently registered devices listed for He Chuang Plastic & Rubber Co., Ltd. include Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs.
Which FDA establishments are linked to He Chuang Plastic & Rubber Co., Ltd.?
1 FDA establishment is linked to He Chuang Plastic & Rubber Co., Ltd. in the registry; they are listed on the company page.