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FDA 510(k)

Protective Gown AAMI Level 4

K-Number: K222128 · 2023-08-08

ApplicantKenpax International Limited
Decision Date2023-08-08
Product CodeQPC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Protective Gown AAMI Level 4 is the device name listed in this FDA 510(k) record. The listed applicant is Kenpax International Limited. It received FDA 510(k) clearance on 2023-08-08 under 510(k) 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. The listed applicant is Kenpax International Limited. The 510(k) number is K222128.

When did Protective Gown AAMI Level 4 receive FDA 510(k) clearance?

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

Who is the listed applicant for Protective Gown AAMI Level 4?

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

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 records listing Kenpax International Limited 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.

K222151Sterilization WrapK212504Isolation Gown AAMI Level 3K202899Procedure Mask, Surgical Mask

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.K212464Dukal Corporation AAMI Level 4 Open-Back Protective GownDukal Corporation

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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