Cleared Traditional

Donagamex Blue Performance Protective Gown

K203821 · Dong Nai Garment Corporation (Donagamex) · General Hospital

Dec 2021

Decision

353d

Days

Class 2

Risk

About This 510(k) Submission

K203821 is an FDA 510(k) clearance for the Donagamex Blue Performance Protective Gown, a Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection (Class II — Special Controls, product code QPC), submitted by Dong Nai Garment Corporation (Donagamex) (Bien Hoa City, VN). The FDA issued a Cleared decision on December 17, 2021, 353 days after receiving the submission on December 29, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K203821 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2020
Decision Date	December 17, 2021
Days to Decision	353 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	QPC — Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4040
Definition	A Non-sterile, Non-isolation Gown Intended To Be Worn By Healthcare Personnel To Provide Moderate Or High Barrier Protection In Non-sterile And Non Patient Isolation Situations. Gowns With Antimicrobial/antiviral Agents Or Claims Are Excluded.