# K203821: Donagamex Blue Performance Protective Gown

- Pathway: 510(k) (Traditional)
- Applicant: Dong Nai Garment Corporation (Donagamex)
- Decided: Dec 17, 2021 after 353 days
- Product code: QPC (Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925077 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160337: Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns, Bam Corporation Limited (2017) Summary page 5.

## Indications for use
Donagamex protective gowns are non-sterile, single use surgical apparel intended to be worn by healthcare personnel to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Donagamex protective gowns meet the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/AAMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70). The Donagamex protective gowns are sold non-sterile, single use. They are not intended for use in the operating room.

Source page: https://510kreport.com/device/K203821
Methodology: https://510kreport.com/methodology