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FDA 510(k)

Cardinal HealthTM Poly-Coated Open-Back Protective Gown

K-Number: K182830 · 2019-04-26

ApplicantCardinal Health200, LLC
Decision Date2019-04-26
Product CodeQPC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cardinal HealthTM Poly-Coated Open-Back Protective Gown is a medical device manufactured by Cardinal Health200, LLC. It received FDA 510(k) clearance on 2019-04-26 under approval number K182830. 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 Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

Cardinal HealthTM Poly-Coated Open-Back Protective Gown is a medical device that received FDA 510(k) clearance on 2019-04-26. It is manufactured by Cardinal Health200, LLC. The 510(k) number is K182830.

When was Cardinal HealthTM Poly-Coated Open-Back Protective Gown approved by the FDA?

Cardinal HealthTM Poly-Coated Open-Back Protective Gown received FDA 510(k) clearance on 2019-04-26, under approval number K182830.

What company makes Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

Cardinal HealthTM Poly-Coated Open-Back Protective Gown is manufactured by Cardinal Health200, LLC.

What is the FDA product code for Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

The FDA product code for Cardinal HealthTM Poly-Coated Open-Back Protective Gown is QPC.

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Related Devices (Code: QPC)

K160337Safecare Open Back Protective Gowns and ValueCare Open Back Protective GownsBam Corporation Limited 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. 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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