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510(k) K203821

Donagamex Blue Performance Protective Gown by Dong Nai Garment Corporation (Donagamex) — Product Code QPC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2021
Date Received
December 29, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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.

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