Taizhou Xinkang Medical Materials Co., Ltd.
Manufacturer and brand owner in Taizhou, Jiangsu, China. 35 device types, 1 product catalogued.
Taizhou Xinkang Medical Materials Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Forceps, Pad, Eye and 33 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
35device types registered with the FDA
1product
Registration
| Registered name | TAIZHOU XINKANG MEDICAL MATERIALS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005460813 |
| FEI number | 3005460813 |
| DUNS | 527703453 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
Location
| City | Taizhou |
|---|---|
| Province | Jiangsu |
| Address | No. 18, Wuzhou (South) Road |
| Postal code | 225300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Absorbent TIP Applicator: Cotton TIP Applicator | 2019 | 186 |
| Bandage, Elastic | Class 1 | Gauze Bandage, Bandage Elastic | 2013 | 280 |
| Bedding, Disposable, Medical | Class 1 | Emergency Blanket, Emergency Sleeping Bag, Foil Baby bunting | 2013 | 308 |
| Clip, Removable (Skin) | Class 1 | Wound Closure Strips, Wound Closure Device | 2022 | 15 |
| Cotton, Roll | Class 1 | Non-Sterile Cotton Roll, Medium, Dental 40/50/6/Cs | 2014 | 107 |
| Depressor, Tongue, Non-Surgical | Class 1 | Tongue Depressor | 2022 | 100 |
| Device, Pressure Applying | Class 1 | Kangzhu Cupping Set, Cupping Set, Pressure Cupping Set | 2025 | 36 |
| Disinfectant, Medical Devices | Class 1 | Alcohol Prep Pad, Alcohol Swab Sticks, Antiseptic Wipes, Normal Saline Wipe, Povidone-lodine Swab Stick, Cleaning Wipe, Soap Wipe, BZK Wipe: Povidone-lodine Prep Pad, | 2020 | 197 |
| Dressing, Compression | Class 1 | Dressing, Compression | 2015 | 87 |
| Dressing, Wound, Drug | Class U | Silver Alginate Dressing, Calcium Alginate with Silver (Ag) Dressing, Silver Calcium Alginate Dressing | 2026 | 48 |
| Dressing, Wound, Occlusive | Class 1 | Chest Seal | 2022 | 183 |
| Emergency Obstetrical Kit | Class 1 | Emergency Obstetrical Kit, OB Kit | 2021 | 3 |
| Fiber, Medical, Absorbent | Class 1 | Non-sterile Cotton Ball, Sterile Cotton Ball, Absorbent Cotton Ball | 2014 | 172 |
| First Aid Kit With Drug | Class N | First Aid Kit, Trauma Kit, Rescue Kit | 2026 | 57 |
| First Aid Kit Without Drug | Class 1 | First Aid Kit, First Aid Bag, First Aid Case | 2015 | 132 |
| Floss, Dental | Class 1 | Dental Floss | 2026 | 151 |
| Forceps | Class 1 | Plastic Tweezers, Plastic Forceps | 2019 | 99 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Sterile Abdominal Wound Dressing Pads, Gauze Sponges, Non-woven Gauze Sponges, Conbine Pad, Multi-trauma Dressing, Abdominal Pad, Non-adherent Pad | 2013 | 266 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Class U | Zeolite Hemostatic Gauze | 2025 | 10 |
| Light, Examination, Medical, Battery Powered | Class 1 | Battery-powered medical examination light, Penlight | 2024 | 53 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | CPR-Aid Rescuer Device, Single Use | 2016 | 72 |
| Mask, Scavenging | Class 1 | Face Mask, Mouth To Mouth Mask | 2016 | 158 |
| Mouthpiece, Breathing | Class 1 | Mouth TO Mouth Mask, CPR Face Shield | 2026 | 67 |
| Non-Surgical Gown | Class 1 | Isolation Gown, CPE Thumb Loop Isolation Gowns | 2025 | 318 |
| Pack, Hot Or Cold, Disposable | Class 1 | Instant Ice Pack, Instant Cold Pack, Instant Hot Pack | 2019 | 176 |
| Pad, Eye | Class 1 | Eye Pad | 2016 | 100 |
| Polymer Patient Examination Glove | Class 1 | Powder Free Nitrile Patient Examination Glove, Polymer Patient Examination Glove, Non-Powdered Patient Examination Glove, Medical Nitrile Glove, Nitrile Glove, Disposable Nitrile Gloves, Nitrile Examination Gloves, Nitrile Gloves | 2024 | 83 |
| Scissors, General, Surgical | Class 1 | Medical Scissors, Bandage Scissors, EMT Shears | 2024 | 83 |
| Skin Prep Tray | Class 1 | Skin Prep Tray | 2025 | 8 |
| Sling, Arm | Class 1 | Triangular Bandage | 2013 | 126 |
| Solution, Isotonic | Class 1 | Saline Solution, Skin Wash | 2024 | 16 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | Finger Splint, Flat Splint, Wrist and Arm Flat Splint, SPLINT | 2025 | 62 |
| Tape And Bandage, Adhesive | Class 1 | Adhesive Bandage 2″x3″, 3″x4″, 4″x4″, 4″x6″, 4″x8″, Bandage Fabric, butterfly wound closure, 3/4″x3″, 1″x3″, spot bandage, 2″x3″, knee&elbow, fingertip, knuckle, Surgical Tape (Clear/Cloth/Non-Woven/Waterproof) 1/2″x2 1/2y, 1/2″x3y, 1/2″x5y, 1/2″x10y, 1″x 5y, 1″x10y, Bandage PE skin color 3/4″x3″, 1″x3″, junior bandage, spot bandage, 2″x3″, knee&elbow, Transparent Dressing, Wound Closure Strips | 2021 | 353 |
| Tracheotomy Care Kit | Class 2 | Tracheotomy care kit | 2025 | 2 |
| Vinyl Patient Examination Glove | Class 1 | Vinyl Patient Examination Gloves | 2026 | 72 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| OEM | KME | 1 |
Clearances
No clearance names Taizhou Xinkang Medical Materials Co., Ltd. as applicant. 5 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K223495 | 2023-05-02 | QSY | Traditional | Hangzhou ZEO-Innov Life Technology Co., Ltd. |
| K182043 | 2018-09-21 | LYZ | Traditional | Hebei Titans Hongsen Medical Technology Co., Ltd. |
| K150340 | 2015-06-18 | LZA | Traditional | Hebei Hongsen Plastics Technology Co., Ltd. |
| K143335 | 2015-06-01 | FRO | Traditional | Roosin Medical Devices Co., Ltd. |
| K131440 | 2013-09-25 | LZA | Traditional | Hebei Hongsen Plastics Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Employees | 11-50 |
| Main products | Emergency blankets, Triangular bandages, Gauze swabs, First-aid kits |
| Certifications | ISO13485:2003, CE |
| Export markets | Europe, Australia |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.