Data / Medical devices / China / Shandong Intco Medical Products Co Ltd
Shandong Intco Medical Products Co Ltd: FDA-registered device maker in Qingzhou Shandong, China, 5 510(k) clearances
Shandong Intco Medical Products Co Ltd is registered with the FDA (registration 3011391433) in Qingzhou Shandong, China. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 22, 2023. 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
- 3011391433
- Address
- 9888 Qiwang Road Naoshan Industrial Park, Qingzhou Shandong, China, 262500
- Owner or operator
- Shandong Intco Medical Products Co Ltd (10048737)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 7, 2016
- Registered through
- 2026
- Brand names listed
- Electrode, electrocardiograph, Latex Examination Gloves, Medical face mask, Nitrile examination glove, Sterile Latex Examination Gloves Powder Free, Vinyl examination glove, nitrile examination glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | 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 |
|---|---|---|---|---|---|---|
| February 22, 2023 | K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) | LYY | Substantially Equivalent | Shandong Intco Medical Products Co, Ltd. | accessdata.fda.gov |
| April 8, 2022 | K213509 | Latex Examination Gloves, Powder Free | LYY | Substantially Equivalent | Shandong Intco Medical Products Co, Ltd. | accessdata.fda.gov |
| March 30, 2021 | K202708 | Surgical Face Masks | FXX | Substantially Equivalent | Intco Medical(Hk) Co., Ltd. | accessdata.fda.gov |
| August 25, 2017 | K170136 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Shandong Feiyang Professional Gloves Co., Ltd. | accessdata.fda.gov |
| January 7, 2014 | K131832 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Shandong Binxiang Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Mask, Surgical
- All makers of Vinyl Patient Examination Glove
- All makers of Electrode, Electrocardiograph
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
Updated February 22, 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.