Gem Nonwovews, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Gem Nonwovews, Inc. makes
Gem Nonwovens, Inc. manufactures single-use protective apparel, including disposable shoe covers and bouffant caps designed for clinical and industrial environments. These items are made from nonwoven materials intended for barrier protection and contamination control.
The company’s products fall under FDA Class I medical devices and are listed via the 510(k) pathway. These items are regulated under U.S. jurisdiction and comply with applicable U.S. medical device standards.
Catalogue
Disposable Shoe Cover Ref K913628
Regimes: 510(k) Registry: 510(k)Disposable Bouffant Cap Ref K913700
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gem Nonwovews, Inc. have in the registry?
The registry currently lists 2 devices for Gem Nonwovews, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gem Nonwovews, Inc.'s devices?
Among its 2 most recently registered devices, Gem Nonwovews, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Gem Nonwovews, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Gem Nonwovews, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Gem Nonwovews, Inc. in the registry?
The most recently registered devices listed for Gem Nonwovews, Inc. include DISPOSABLE SHOE COVER and DISPOSABLE BOUFFANT CAP.