Isolation Gown AAMI Level 3
K-Number: K212504 · 2021-11-07
ApplicantKenpax International Limited
Decision Date2021-11-07
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Isolation Gown AAMI Level 3 is a medical device manufactured by Kenpax International Limited. It received FDA 510(k) clearance on 2021-11-07 under approval number K212504. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Isolation Gown AAMI Level 3?
Isolation Gown AAMI Level 3 is a medical device that received FDA 510(k) clearance on 2021-11-07. It is manufactured by Kenpax International Limited. The 510(k) number is K212504.
When was Isolation Gown AAMI Level 3 approved by the FDA?
Isolation Gown AAMI Level 3 received FDA 510(k) clearance on 2021-11-07, under approval number K212504.
What company makes Isolation Gown AAMI Level 3?
Isolation Gown AAMI Level 3 is manufactured by Kenpax International Limited.
What is the FDA product code for Isolation Gown AAMI Level 3?
The FDA product code for Isolation Gown AAMI Level 3 is FYC.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.