Data / Medical devices / Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs (QSO): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs (product code QSO, Class 2, 21 CFR 878.4040). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on September 1, 2026, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- QSO
- Device class
- 2
- Regulation
- 878.4040
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 4 |
| Cambodia | 2 |
| Laos | 1 |
| Canada | 1 |
| United States | 1 |
Makers of Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Gushi priMED Medical Products Manufacturing Co., Ltd. | Gushi County Henan, China | Manufacturer | 1 | September 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Liyang Jiangsu, China | Manufacturer | 1 | September 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| PRIMED Laos Medical Products Manufacturing Sole Co., Ltd. | Vientiane Capital Viangchan(Prefecture), Laos | Manufacturer | 1 | September 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Primed Medical Products Inc. | Edmonton Alberta, Canada | Specification developer | 1 | September 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Copioumed International, Inc. | TAIPEI Taiwan, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copious (cambodia) International Inc. | Takeo, Cambodia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtecs (cambodia) Corp. Limited | Srok Kampong Siem Kampong Cham, Cambodia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.