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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 a medical device manufactured by Dong Nai Garment Corporation (Donagamex). It received FDA 510(k) clearance on 2021-12-17 under approval 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. It is manufactured by Dong Nai Garment Corporation (Donagamex). The 510(k) number is K203821.

When was Donagamex Blue Performance Protective Gown approved by the FDA?

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

What company makes Donagamex Blue Performance Protective Gown?

Donagamex Blue Performance Protective Gown is manufactured by Dong Nai Garment Corporation (Donagamex).

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

The FDA product code for Donagamex Blue Performance Protective Gown is QPC.

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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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