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FDA 510(k)

Donagamex Blue Performance Protective Gown

K-Number: K203821 · 2021-12-17

ApplicantDong Nai Garment Corporation (Donagamex)
Decision Date2021-12-17
Product CodeQPC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Donagamex Blue Performance Protective Gown is the device name listed in this FDA 510(k) record. The listed applicant is Dong Nai Garment Corporation (Donagamex). It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K203821. 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 Donagamex Blue Performance Protective Gown?

Donagamex Blue Performance Protective Gown is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Dong Nai Garment Corporation (Donagamex). The 510(k) number is K203821.

When did Donagamex Blue Performance Protective Gown receive FDA 510(k) clearance?

Donagamex Blue Performance Protective Gown received FDA 510(k) clearance on 2021-12-17, under 510(k) number K203821.

Who is the listed applicant for Donagamex Blue Performance Protective Gown?

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

What is the FDA product code for Donagamex Blue Performance Protective Gown?

The FDA product code for Donagamex Blue Performance Protective 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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