Wuhan Zonsen Medical Products Co., Ltd
Wuhan Hubei, CN
WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD appears in FDA device records in Wuhan Hubei, CN. FDA records list 6 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Wuhan Zonsen Medical Products Co., Ltd between 2021 and 2023. The busiest year on record is 2022, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223600 | Sterilization Wrap | FRG | Substantially Equivalent | |
| K213601 | Surgical Mask | FXX | Substantially Equivalent | |
| K213688 | Nitrile Examination Gloves (Model: ZMG1351) | LZA | Substantially Equivalent | |
| K212357 | Surgical isolation gown | FYC | Substantially Equivalent | |
| K212861 | Surgical Gown, Reinforced Surgical Gown | FYA | Substantially Equivalent | |
| K202191 | Surgical Mask | FXX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015140351 | 3015140351 | WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD | No. 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan Hubei 431000 CN | 2026 | and 14 more, listed in full below |
| 3042285072 | 3042285072 | WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD | No. 8 Zhiyuan Road, Yangluo Economy Development District, Xinzhou District, Wuhan Hubei 430415 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- FQMBandage, Elastic
- KMEBedding, Disposable, Medical
- GECBrush, Scrub, Operating-Room
- FYFCap, Surgical
- LGFComponent, Cast
- EFNCotton, Roll
- FXPCover, Shoe, Operating-Room
- LRJDisinfectant, Medical Devices
- PUIDrape, Surgical, Exempt
- QKRFace Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- LRRFirst Aid Kit With Drug
- NABGauze / Sponge,Nonresorbable For External Use
- FMEGown, Examination
- FYCGown, Isolation, Surgical
- FYAGown, Surgical
- KHAMask, Scavenging
- FXXMask, Surgical
- OEANon-Surgical Gown
- HHDPad, Menstrual, Unscented
- LZAPolymer Patient Examination Glove
- FXOSuit, Surgical
- KGXTape And Bandage, Adhesive
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain