Data / Medical devices / China / Taizhou Xinkang Medical Materials Co., Ltd
Taizhou Xinkang Medical Materials Co., Ltd: FDA-registered device maker in Taizhou Jiangsu, China, 5 510(k) clearances
Taizhou Xinkang Medical Materials Co., Ltd is registered with the FDA (registration 3005460813) in Taizhou Jiangsu, China. It lists 34 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 2, 2023. Registered through 2027. FDA data exported November 2, 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
- 3005460813
- Address
- No. 18, Wuzhou (South) Road, Taizhou Jiangsu, China, 225300
- Owner or operator
- Taizhou Xinkang Medical Materials Co., Ltd (10045001)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- September 10, 2013
- Registered through
- 2027
- Brand names listed
- ABSORBENT TIP APPLICATOR: COTTON TIP APPLICATOR, Adhesive Bandage 2"x3", 3"x4", 4"x4", 4"x6", 4"x8", Alcohol Prep Pad, Alcohol Swab Sticks, Antiseptic Wipes, Normal Saline Wipe, Bandage Fabric, butterfly wound closure, 3/4"x3", 1"x3", spot bandage, 2"x3", knee&elbow, fingertip, knuckle, Bandage PE skin color 3/4"x3", 1"x3", junior bandage, spot bandage, 2"x3", knee&elbow, Battery-powered medical examination light, Penlight, CPR-Aid Rescuer Device, Single Use, Chest Seal and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Manufacturer | accessdata.fda.gov |
| Clip, Removable (Skin) | FZQ | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, Pressure Applying | KNM | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Emergency Obstetrical Kit | OKU | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Manufacturer | accessdata.fda.gov |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Skin Prep Tray | OJU | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Manufacturer | accessdata.fda.gov |
| Solution, Isotonic | JCE | 1 | Contract manufacturer, Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tracheotomy Care Kit | NXA | 2 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 2, 2023 | K223495 | Zeolite Hemostatic Cotton | QSY | Substantially Equivalent | Hangzhou Zeo-Innov Life Technology Co., Ltd. | accessdata.fda.gov |
| September 21, 2018 | K182043 | Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) | LYZ | Substantially Equivalent | Hebei Titans Hongsen Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 18, 2015 | K150340 | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) | LZA | Substantially Equivalent | Hebei Hongsen Plastics Technology Co, Ltd. | accessdata.fda.gov |
| June 1, 2015 | K143335 | Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) | FRO | Substantially Equivalent | Roosin Medical Devices Co., Ltd. | accessdata.fda.gov |
| September 25, 2013 | K131440 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Hebei Hongsen Plastics Technology Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of First Aid Kit Without Drug
- All makers of Mouthpiece, Breathing
- All makers of Polymer Patient Examination Glove
- All makers of Scissors, General, Surgical
- All makers of Bandage, Elastic
- All makers of Pack, Hot Or Cold, Disposable
Updated May 2, 2023. 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.