Data / Medical devices / China / Jiangxi 3L Medical Products Group Co., Ltd
Jiangxi 3L Medical Products Group Co., Ltd: FDA-registered device maker in Nanchang Jiangxi, China, 2 510(k) clearances
Jiangxi 3L Medical Products Group Co., Ltd is registered with the FDA (registration 3004133236) in Nanchang Jiangxi, China. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 25, 2020. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004133236
- Address
- No.599, Huoju Street High-tech Development Zone, Nanchang Jiangxi, China, 330029
- Owner or operator
- JIANGXI 3L MEDICAL PRODUCTS GROUP CO., LTD (9058101)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 18, 2003
- Registered through
- 2026
- Brand names listed
- 3L SURGICAL DRAPE, 40g SMS FABRIC (FJ100*70), 55gr laminted film drape-layer with fluid collection pouch (FJ303007, FJ120X100S), Adhesive Wound Dressing (FB0508, FB0910, FB0915, FB0920, FB1015, FB0925, FB1020, FB1025, FB1030, FB1035, FB1040), C arm drape cover (195cmx111cm), CRANIOTOMY DRAPE (FJ301059), Cesarean Section drape Sheet (254x291cm, 254x307cm), Disposable Medical Face Mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 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 |
|---|---|---|---|---|---|---|
| September 25, 2020 | K202277 | Surgical Face Mask | FXX | Substantially Equivalent | Jiangxi 3l Medical Products Group Co., Ltd. | accessdata.fda.gov |
| August 15, 2005 | K043015 | 3L SURGICAL DRAPES | KKX | Substantially Equivalent | 3l Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Drape, Surgical, Exempt
- All makers of Mask, Surgical
- All makers of Accessory, Surgical Apparel
- All makers of Drape, Surgical, Antimicrobial
- All makers of Respirator, Surgical
- All makers of Tape And Bandage, Adhesive
Updated September 25, 2020. 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.