Donagamex Blue Performance Protective Gown— 510(k) K203821

Name: FDA 510(k) clearance K203821
Creator: U.S. Food and Drug Administration
Published: 2021-12-17

Substantially Equivalent

Dong Nai Garment Corporation (Donagamex)

FDA 510(k) clearance K203821 for Donagamex Blue Performance Protective Gown, Substantially Equivalent on 2021-12-17. Applicant: Dong Nai Garment Corporation (Donagamex). Device class: 2.

Clearance details

Applicant: Dong Nai Garment Corporation (Donagamex)
Product code: Code QPC
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2020-12-29
Decision date: 2021-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bien Hoa City, VN

Download summary PDF View on FDA.gov ↗

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