Protect X Level 3 Isolation Gown
K-Number: K211538 · 2021-11-17
ApplicantAzac Group
Decision Date2021-11-17
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Protect X Level 3 Isolation Gown is a medical device manufactured by Azac Group. It received FDA 510(k) clearance on 2021-11-17 under approval number K211538. 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 Protect X Level 3 Isolation Gown?
Protect X Level 3 Isolation Gown is a medical device that received FDA 510(k) clearance on 2021-11-17. It is manufactured by Azac Group. The 510(k) number is K211538.
When was Protect X Level 3 Isolation Gown approved by the FDA?
Protect X Level 3 Isolation Gown received FDA 510(k) clearance on 2021-11-17, under approval number K211538.
What company makes Protect X Level 3 Isolation Gown?
Protect X Level 3 Isolation Gown is manufactured by Azac Group.
What is the FDA product code for Protect X Level 3 Isolation Gown?
The FDA product code for Protect X Level 3 Isolation Gown 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.