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FDA 510(k)

Dukal Corporation AAMI Level 4 Open-Back Protective Gown

K-Number: K212464 · 2022-03-30

ApplicantDukal Corporation
Decision Date2022-03-30
Product CodeQPC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dukal Corporation AAMI Level 4 Open-Back Protective Gown is a medical device manufactured by Dukal Corporation. It received FDA 510(k) clearance on 2022-03-30 under approval number K212464. 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 Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

Dukal Corporation AAMI Level 4 Open-Back Protective Gown is a medical device that received FDA 510(k) clearance on 2022-03-30. It is manufactured by Dukal Corporation. The 510(k) number is K212464.

When was Dukal Corporation AAMI Level 4 Open-Back Protective Gown approved by the FDA?

Dukal Corporation AAMI Level 4 Open-Back Protective Gown received FDA 510(k) clearance on 2022-03-30, under approval number K212464.

What company makes Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

Dukal Corporation AAMI Level 4 Open-Back Protective Gown is manufactured by Dukal Corporation.

What is the FDA product code for Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

The FDA product code for Dukal Corporation AAMI Level 4 Open-Back Protective Gown is QPC.

Other Devices by Dukal Corporation

K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons K210321Dukal Corporation Level 1 Pediatric Face Mask K203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown

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. K230384PolyWear® Personal Protective Level 3 GownPolyConversions, Inc. K222128Protective Gown AAMI Level 4Kenpax International Limited

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.

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