Data / Medical devices / China / Anhui Intco Medical Products Co., Ltd.
Anhui Intco Medical Products Co., Ltd.: FDA-registered device maker in Huaibei Anhui, China, 6 510(k) clearances
Anhui Intco Medical Products Co., Ltd. is registered with the FDA (registration 3017610877) in Huaibei Anhui, China. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017610877
- Address
- No.6 Haitang South Road, Suixi Wuhu Modern Industrial Park No.6, Shuangchuang Avenue, Suixi EconomicDevelopment Zone, Huaibei Anhui, China, 235100
- Owner or operator
- Anhui Intco Medical Products Co., Ltd. (10077996)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 7, 2020
- Registered through
- 2026
- Brand names listed
- Nitrile Examination Glove 3.5 , Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Nitrile Patient Examination Gloves, Powder Free, Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Synthetic Nitrile Patient Examination Gloves, Powder Free, and Tested for Use with Chemotherapy Drugs
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 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 |
|---|---|---|---|---|---|---|
| April 8, 2024 | K240021 | Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Yue Kang Anhui Medical Products Co., Ltd. | accessdata.fda.gov |
| January 26, 2024 | K233598 | Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs | LZA | Substantially Equivalent | Anhui Intco Medical Products Co., Ltd. | accessdata.fda.gov |
| August 24, 2023 | K222103 | Nitrile Patient Examination Gloves, Powder Free, Pink Color | LZA | Substantially Equivalent | Shandong Yinghng Medical Products Co., Ltd. | accessdata.fda.gov |
| August 20, 2020 | K200093 | Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug | LZA | Substantially Equivalent | Anhui Lntco Medical Products Co., Ltd. | accessdata.fda.gov |
| July 22, 2019 | K191092 | Powder-Free Vinyl Patient Examination Gloves, Yellow Color | LYZ | Substantially Equivalent | Anhui Intco Medical Products Co., Ltd. | accessdata.fda.gov |
| June 20, 2019 | K190095 | Powder-Free Clear Vinyl Patient Examination Gloves | LYZ | Substantially Equivalent | Anhui Intco Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Vinyl Patient Examination Glove
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated April 8, 2024. 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.