FDA 510(k)

Protective Gown AAMI Level 4

K-Number: K222128 · 2023-08-08

Decision Date2023-08-08

Product CodeQPC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Protective Gown AAMI Level 4 is a medical device manufactured by Kenpax International Limited. It received FDA 510(k) clearance on 2023-08-08 under approval number K222128. 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 Protective Gown AAMI Level 4?

Protective Gown AAMI Level 4 is a medical device that received FDA 510(k) clearance on 2023-08-08. It is manufactured by Kenpax International Limited. The 510(k) number is K222128.

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

Protective Gown AAMI Level 4 received FDA 510(k) clearance on 2023-08-08, under approval number K222128.

What company makes Protective Gown AAMI Level 4?

Protective Gown AAMI Level 4 is manufactured by Kenpax International Limited.

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

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

Other Devices by Kenpax International Limited

K212504Isolation Gown AAMI Level 3 K202899Procedure Mask, Surgical Mask K222151Sterilization Wrap

Related Devices (Code: QPC)

K160337Safecare Open Back Protective Gowns and ValueCare Open Back Protective GownsBam Corporation Limited K182830Cardinal HealthTM Poly-Coated Open-Back Protective GownCardinal Health200, LLC K203821Donagamex Blue Performance Protective GownDong Nai Garment Corporation (Donagamex) K210405ProTEC-USA EZDoff GownCadillac Products, Inc. K212464Dukal Corporation AAMI Level 4 Open-Back Protective GownDukal Corporation K230384PolyWear® Personal Protective Level 3 GownPolyConversions, Inc.

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.