American Seal Co.
Country not established
- Devices
- 6
What American Seal Co. makes
American Seal Co. manufactures single-use personal protective barriers, including shoe covers, bouffant caps, non-sterile isolation gowns, and latex examination gloves for patient and provider use. Their product line also includes surgical face masks designed for procedural protection in clinical settings.
The company’s devices are regulated under FDA Class I and Class II classifications, with relevant products listed via the 510(k) pathway. These items are distributed in the United States, where the manufacturer is based.
Catalogue
Shoe Cover Ref K972227
Regimes: 510(k) Registry: 510(k)Bouffant Cap Ref K972187
Regimes: 510(k) Registry: 510(k)Non-Sterile Isolation Gown Ref K970814
Regimes: 510(k) Registry: 510(k)Maytex Non-Sterile Latex Exam Glove Ref K892557
Regimes: 510(k) Registry: 510(k)Maytex Patient Examination Gloves Ref K892553
Regimes: 510(k) Registry: 510(k)Amseal Surgical Face Mask Ref K964358
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Seal Co. have in the registry?
The registry currently lists 6 devices for American Seal Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Seal Co.'s devices?
Among its 6 most recently registered devices, American Seal Co. has devices listed in FDA 510(k) (6 devices).
What risk classes do American Seal Co.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for American Seal Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Seal Co. in the registry?
The most recently registered devices listed for American Seal Co. include SHOE COVER, BOUFFANT CAP, NON-STERILE ISOLATION GOWN and MAYTEX NON-STERILE LATEX EXAM GLOVE.