Medtek Development Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Medtek Development Corp. makes
Medtek Development Corp. manufactures single-use personal protective equipment, including disposable gowns, aprons, shoe covers, and comprehensive protection kits designed for medical and industrial environments.
These products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The company operates from the United States.
Catalogue
Poly-Med Disposable Personal Protection Kit Ref K930026
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medtek Development Corp. have in the registry?
The registry currently lists 2 devices for Medtek Development Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtek Development Corp.'s devices?
Among its 2 most recently registered devices, Medtek Development Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Medtek Development Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Medtek Development Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medtek Development Corp. in the registry?
The most recently registered devices listed for Medtek Development Corp. include POLY-MED DISPOSABLE PERSONAL PROTECTION KIT and POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS.