Data / Medical devices / China / Premier Guard Zhongshan Limited
Premier Guard Zhongshan Limited: FDA-registered device maker in Zhongshan Guangdong, China, 1 510(k) clearance
Premier Guard Zhongshan Limited is registered with the FDA (registration 3013046958) in Zhongshan Guangdong, China. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 30, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013046958
- Address
- No 52, Huan Mao Yi Road Torch Development Zone, Zhongshan Guangdong, China, 528400
- Owner or operator
- Premier Guard Global Limited (9031832)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 27, 2005
- Registered through
- 2026
- Brand names listed
- Face Shield, Ice Bag, Premier Guard, Premier Guard Needle Guide, Retainer, Surgical: RMD3202, 3204, 3206, 3206
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bag, Ice | KYR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Clamp | HXD | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Barrier, Protective | MMP | 2 | Manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Retainer, Surgical | GCZ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| November 30, 2004 | K041501 | GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS | MMP | Substantially Equivalent | Guangzhou Fortunique , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cover, Barrier, Protective
- All makers of Protector, Skin Pressure
- All makers of Bag, Ice
- All makers of Guide, Needle, Surgical
- All makers of Orthosis, Limb Brace
- All makers of Retainer, Surgical
Updated November 30, 2004. 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.