Baldur Systems Corp.
United StatesFDA applicant, unverified
- Devices
- 6
What Baldur Systems Corp. makes
Baldur Systems Corp. manufactures single-use medical textiles, including operating room towels, non-sterile cotton sponges, and latex exam gloves produced by external manufacturers. Their portfolio also covers patient examination gloves in latex and vinyl formulations.
The company’s products are classified under FDA categories Class I, Class II, and Unclassified (U), with relevant devices listed via the 510(k) pathway. The manufacturer operates from the United States.
Catalogue
Operating Room Towels Ref K981823
Regimes: 510(k) Registry: 510(k)Latex Exam Gloves (Mfg. Rindumas Sdn Bhd) Ref K891727
Regimes: 510(k) Registry: 510(k)Vinyl Exam Gloves (Mfg. Sun Flower Glove Co.) Ref K891726
Regimes: 510(k) Registry: 510(k)Latex Exam Gloves (Mfg. Koon Seng Sdn Bhd) Ref K891728
Regimes: 510(k) Registry: 510(k)Baldur Non-Sterile Cotton Sponges Ref K974347
Regimes: 510(k) Registry: 510(k)Patient Examination Gloves (Latex) Ref K892684
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Baldur Systems Corp. have in the registry?
The registry currently lists 6 devices for Baldur Systems Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Baldur Systems Corp.'s devices?
Among its 6 most recently registered devices, Baldur Systems Corp. has devices listed in FDA 510(k) (6 devices).
What risk classes do Baldur Systems Corp.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Baldur Systems Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Baldur Systems Corp. in the registry?
The most recently registered devices listed for Baldur Systems Corp. include OPERATING ROOM TOWELS, LATEX EXAM GLOVES (MFG. RINDUMAS SDN BHD), VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.) and LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD).