Biosafety Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Biosafety Systems, Inc. makes
Biosafety Systems, Inc. manufactures protective nitrile gloves designed for chemical resistance and medical examination use, including powder-free variants and high-risk chemical protection models. Their product line includes exam gloves rated for P2 protection, chemo-resistant gloves, and a disposable aerosol containment device (AEROSTAR).
The company’s portfolio comprises Class I and Class II devices, with regulatory authorisation through FDA 510(k) clearances. Products are listed under U.S. regulatory requirements and are manufactured in the United States.
Catalogue
P2 Nitrile Exam Gloves Ref K944095
Regimes: 510(k) Registry: 510(k)P2/Chemo Plus Gloves Ref K900368
Regimes: 510(k) Registry: 510(k)Chemoplus Glove Ref K901411
Regimes: 510(k) Registry: 510(k)P2 Nitrile Exam Gloves Ref K944514
Regimes: 510(k) Registry: 510(k)Chemo Gloves Powder Free (Mfg: Union Industrial) Ref K904130
Regimes: 510(k) Registry: 510(k)Chemoguard, P2 Hirisk Ref K952274
Regimes: 510(k) Registry: 510(k)P2 Exam Gloves Ref K944142
Regimes: 510(k) Registry: 510(k)Aerostar Ref K921313
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biosafety Systems, Inc. have in the registry?
The registry currently lists 8 devices for Biosafety Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biosafety Systems, Inc.'s devices?
Among its 8 most recently registered devices, Biosafety Systems, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Biosafety Systems, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Biosafety Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biosafety Systems, Inc. in the registry?
The most recently registered devices listed for Biosafety Systems, Inc. include P2 NITRILE EXAM GLOVES, P2/CHEMO PLUS GLOVES, CHEMOPLUS GLOVE and CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL).