Grand Monde Trading Co., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Grand Monde Trading Co., Inc. makes
Grand Monde Trading Co., Inc. manufactures patient examination gloves sourced from two manufacturers in Shanghai, China. These gloves are designed for use in clinical settings to maintain hygiene and reduce infection risk during medical examinations.
The company’s gloves fall under FDA Class I medical devices and are listed via the 510(k) pathway. The products are regulated under US jurisdiction and comply with applicable FDA requirements for low-risk devices.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Patient Exam Gloves (Mfg. Shanghai - Changzheng) Ref K892182
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Grand Monde Trading Co., Inc. have in the registry?
The registry currently lists 2 devices for Grand Monde Trading Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Grand Monde Trading Co., Inc.'s devices?
Among its 2 most recently registered devices, Grand Monde Trading Co., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Grand Monde Trading Co., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Grand Monde Trading Co., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Grand Monde Trading Co., Inc. in the registry?
The most recently registered devices listed for Grand Monde Trading Co., Inc. include PATIENT EXAM GLOVES (MFG. SHANGHAI LATEX FACTORY) and PATIENT EXAM GLOVES (MFG. SHANGHAI - CHANGZHENG).