Darchet (USA), Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Darchet (USA), Inc. makes
The company manufactures latex patient examination gloves, including a variant called LEEDAR, designed for clinical use during medical examinations.
These products are classified as Class I devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Patient Examination Gloves (Latex) Ref K891662
Regimes: 510(k) Registry: 510(k)Leedar (Patient Examination Gloves - Latex) Ref K891663
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Darchet (Usa), Inc. have in the registry?
The registry currently lists 2 devices for Darchet (Usa), Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Darchet (Usa), Inc.'s devices?
Among its 2 most recently registered devices, Darchet (Usa), Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Darchet (Usa), Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Darchet (Usa), Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Darchet (Usa), Inc. in the registry?
The most recently registered devices listed for Darchet (Usa), Inc. include PATIENT EXAMINATION GLOVES (LATEX) and LEEDAR (PATIENT EXAMINATION GLOVES - LATEX).