FDA 510(k)

AAMI Level 4 Protective; Gown

K-Number: K242689 · 2025-01-13

Decision Date2025-01-13

Product CodeQPC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AAMI Level 4 Protective; Gown is a medical device manufactured by Azac Group. It received FDA 510(k) clearance on 2025-01-13 under approval number K242689. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AAMI Level 4 Protective; Gown?

AAMI Level 4 Protective; Gown is a medical device that received FDA 510(k) clearance on 2025-01-13. It is manufactured by Azac Group. The 510(k) number is K242689.

When was AAMI Level 4 Protective; Gown approved by the FDA?

AAMI Level 4 Protective; Gown received FDA 510(k) clearance on 2025-01-13, under approval number K242689.

What company makes AAMI Level 4 Protective; Gown?

AAMI Level 4 Protective; Gown is manufactured by Azac Group.

What is the FDA product code for AAMI Level 4 Protective; Gown?

The FDA product code for AAMI Level 4 Protective; Gown is QPC.

Other Devices by Azac Group

K211538Protect X Level 3 Isolation Gown

Related Devices (Code: QPC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.