Donagamex Blue Performance Protective Gown

Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection

Dong Nai Garment Corporation (Donagamex)

The following data is part of a premarket notification filed by Dong Nai Garment Corporation (donagamex) with the FDA for Donagamex Blue Performance Protective Gown.

Pre-market Notification Details

Device IDK203821
510k NumberK203821
Device Name:Donagamex Blue Performance Protective Gown
ClassificationGown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection
Applicant Dong Nai Garment Corporation (Donagamex) Road 2, Bien Hoa Industrial Zone 1 An Binh Ward Bien Hoa City,  VN 810000
ContactBui The Kich
CorrespondentBari Steinberg
mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck,  NY  11021
Product CodeQPC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-29
Decision Date2021-12-17

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