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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 the device name listed in this FDA 510(k) record. The listed applicant is Dukal Corporation. It received FDA 510(k) clearance on 2022-03-30 under 510(k) 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. The listed applicant is Dukal Corporation. The 510(k) number is K212464.

When did Dukal Corporation AAMI Level 4 Open-Back Protective Gown receive FDA 510(k) clearance?

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

Who is the listed applicant for Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

The FDA 510(k) record lists Dukal Corporation as the applicant. This does not by itself establish the device manufacturer.

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 records listing Dukal Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252823Dukal Crepe Paper Sterilization WrapK233262Dukal SMS Sterilization WrapK210321Dukal Corporation Level 1 Pediatric Face MaskK203237Dukal 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 GownK201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie OnK201421Dukal 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

View all 7 devices →

Related Devices (Code: QPC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261115VR® Personal Protective Level 4 Gown (VR Gowns)PolyConversions, Inc.K252940VR® Personal Protective Level 3 Gown (VR Gowns)PolyConversions, Inc.K242689AAMI Level 4 Protective; GownAzac GroupK233526Medline Open-back Level 3 Protective GownMedline Industries, LPK230384PolyWear® 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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