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FDA 510(k)

Medline Open-back Level 3 Protective Gown

K-Number: K233526 · 2024-03-05

ApplicantMedline Industries, LP
Decision Date2024-03-05
Product CodeQPC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Open-back Level 3 Protective Gown is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2024-03-05 under 510(k) number K233526. 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 Medline Open-back Level 3 Protective Gown?

Medline Open-back Level 3 Protective Gown is a medical device that received FDA 510(k) clearance on 2024-03-05. The listed applicant is Medline Industries, LP. The 510(k) number is K233526.

When did Medline Open-back Level 3 Protective Gown receive FDA 510(k) clearance?

Medline Open-back Level 3 Protective Gown received FDA 510(k) clearance on 2024-03-05, under 510(k) number K233526.

Who is the listed applicant for Medline Open-back Level 3 Protective Gown?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Open-back Level 3 Protective Gown?

The FDA product code for Medline Open-back Level 3 Protective Gown is QPC.

Other records listing Medline Industries, LP 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.

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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 GroupK230384PolyWear® Personal Protective Level 3 GownPolyConversions, Inc.K222128Protective Gown AAMI Level 4Kenpax International LimitedK212464Dukal 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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