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FDA 510(k)

ProTEC-USA EZDoff Gown

K-Number: K210405 · 2021-12-15

ApplicantCadillac Products, Inc.
Decision Date2021-12-15
Product CodeQPC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ProTEC-USA EZDoff Gown is the device name listed in this FDA 510(k) record. The listed applicant is Cadillac Products, Inc.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K210405. 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 ProTEC-USA EZDoff Gown?

ProTEC-USA EZDoff Gown is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Cadillac Products, Inc.. The 510(k) number is K210405.

When did ProTEC-USA EZDoff Gown receive FDA 510(k) clearance?

ProTEC-USA EZDoff Gown received FDA 510(k) clearance on 2021-12-15, under 510(k) number K210405.

Who is the listed applicant for ProTEC-USA EZDoff Gown?

The FDA 510(k) record lists Cadillac Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProTEC-USA EZDoff Gown?

The FDA product code for ProTEC-USA EZDoff Gown is QPC.

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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