510(k) · Cleared
ClearedDonagamex Blue Performance Protective Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dong Nai Garment Corporation (Donagamex) · QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Cleared on Dec 17, 2021 as substantially equivalent to K160337 (Bam Corporation Limited, 2017) after a 353-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Dec 17, 2021
- Review
- 353 days
- Class
- Class II
- Product code
- QPC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925077 (1993). No later device cites it as a predicate yet.
- Root · 2 generations backK925077 Poly-Med Disp. Pers. Prot. Gown Apron & ShoecoversMedtek Development Corp. · 1993
- 1 generation backK160337 Safecare Open Back Protective Gowns and ValueCare Open Back…Bam Corporation Limited · 2017
- This deviceK203821 Donagamex Blue Performance Protective GownDong Nai Garment Corporation (Donagamex) · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925077 | Poly-Med Disp. Pers. Prot. Gown Apron & Shoecovers | Medtek Development Corp. | 1993 | — |
| −1 | K160337 | Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns | Bam Corporation Limited | 2017 | — |
| 0 (this device) | K203821 | Donagamex Blue Performance Protective Gown | Dong Nai Garment Corporation (Donagamex) | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QPC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QPC device
- #1 K262007 PRIMED AAMI Level 3 Open Back Gownsscore 12.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160337 | Safecare Open Back Protective Gowns and ValueCare Open Back Protective GownsSummary page 5…Regulation Name: Surgical Apparel Product Code: QPC Common Name: Gown, Non-Sterile, Non-Isolation 4. Predicate Device Information: 510K Number: K160337 Device Name: ValueCare Open Back Protective Gown 5. Intended Use: Donagamex protective gowns are non-sterile, single us… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 23.9 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K160337.
How does its category compare?
All QPC devicesQPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QPC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QPC
Too few QPC 510(k)s in any year since 2007 to give a median.
Recalls per year · QPC
No recall names QPC since 2007.
Adverse event reports per year · QPC
No MAUDE report names QPC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203821: Donagamex Blue Performance Protective Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203821
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026