Data / Medical devices / China / Gushi priMED Medical Products Manufacturing Co., Ltd.
Gushi priMED Medical Products Manufacturing Co., Ltd.: FDA-registered device maker in Gushi County Henan, China, 1 510(k) clearance
Gushi priMED Medical Products Manufacturing Co., Ltd. is registered with the FDA (registration 3009540572) in Gushi County Henan, China. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009540572
- Address
- Plant 18#, 20# Taiwanese Industry Park, Gushi County Henan, China, 465200
- Owner or operator
- PRIMED Medical Products Inc. (9030179)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 12, 2000
- Registered through
- 2027
- Brand names listed
- PRIMED Chemo drug Tested gowns
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer | accessdata.fda.gov |
| Dress, Surgical | FYE | 1 | Contract manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Contract manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer | accessdata.fda.gov |
| Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs | QSO | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 1, 2026 | K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) | QSO | Substantially Equivalent | PRIMED Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Shield, Protective, Personnel
- All makers of Accessory, Surgical Apparel
- All makers of Cover, Shoe, Operating-Room
- All makers of Gown, Examination
- All makers of Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
- All makers of Gown, Isolation, Surgical
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.