Premium Plastics, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Premium Plastics, Inc. makes
Premium Plastics, Inc. manufactures single-use medical trays and kits for wound care, tracheostomy management, and suctioning, including sterile pressure sore and laceration trays, urethral catheterization sets, and suction catheter trays with attached water. The company also produces sharps disposal systems and sterile sponge bowls for procedural use.
The portfolio includes devices classified as Class I, Class II, and unclassified (U), with many authorised via the FDA’s 510(k) pathway. Products are listed under U.S. regulatory requirements and are intended for use in clinical and home healthcare settings.
Catalogue
Pulm O2 Suction Catheter Trays Ref K953226
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Gent-L-Kare Tracheostomy Trays Ref K950851
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Sterile Sponge Bowls Ref K800440
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Sterile Suture Removal Kit Ref K771448
Regimes: 510(k) Registry: 510(k)Gent-L-Kare Laceration Trays Ref K950850
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Premium Plastics, Inc. have in the registry?
The registry currently lists 9 devices for Premium Plastics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Premium Plastics, Inc.'s devices?
Among its 9 most recently registered devices, Premium Plastics, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Premium Plastics, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Premium Plastics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Premium Plastics, Inc. in the registry?
The most recently registered devices listed for Premium Plastics, Inc. include PULM O2 SUCTION CATHETER TRAYS, GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT, GENT-L-KARE TRACHEOSTOMY TRAYS and GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY.