Medical Device Manufacturer · US , Reno , NV

Ansell Healthcare

1 submissions · 1 cleared · Since 2023

Total

Cleared

Denied

Ansell Healthcare — FDA 510(k) Submissions

Ansell Healthcare has submitted 1 FDA 510(k) premarket notifications since 2023, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Surgeon's Gloves . Use the specialty filter in the sidebar to narrow results.

1 devices

1–1 of 1

GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)

K231902 · KGO Surgeon's Gloves · General Hospital

Oct 2023 114d

Ansell Healthcare

Ansell Healthcare — FDA 510(k) Submissions

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