Neo-Sigma, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Neo-Sigma, Inc. makes
Neo-Sigma, Inc. manufactures vinyl and latex exam gloves for medical and clinical use, sourced from multiple manufacturers including Precious Mountain Ent., JM Gloves Co. Ltd., Yeou Jih Industrial Co., and AM Gloves Co. Ltd.
These products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Vinyl Exam Gloves (Mfg. Precious Mountain Ent.) Ref K891567
Regimes: 510(k) Registry: 510(k)Vinyl Exam Gloves (Mfg. Jm Gloves Co. Ltd.) Ref K891568
Regimes: 510(k) Registry: 510(k)Latex Exam Gloves (Mfg. Yeou Jih Industrial Co.) Ref K891841
Regimes: 510(k) Registry: 510(k)Vinyl Exam Gloves (Mfg. Am Gloves Co. Ltd.) Ref K891566
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Neo-Sigma, Inc. have in the registry?
The registry currently lists 4 devices for Neo-Sigma, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neo-Sigma, Inc.'s devices?
Among its 4 most recently registered devices, Neo-Sigma, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Neo-Sigma, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Neo-Sigma, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Neo-Sigma, Inc. in the registry?
The most recently registered devices listed for Neo-Sigma, Inc. include VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.), VINYL EXAM GLOVES (MFG. JM GLOVES CO. LTD.), LATEX EXAM GLOVES (MFG. YEOU JIH INDUSTRIAL CO.) and VINYL EXAM GLOVES (MFG. AM GLOVES CO. LTD.).