Anhui Intco Medical Products Co., Ltd.

Registered establishment in Huaibei, Anhui, China. 5 device types, 4 clearances.

Registry build 21.09.26

Anhui Intco Medical Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Medical Glove, Specialty, Vinyl Patient Examination Glove and 3 other device types. Its earliest product listing with the FDA dates from 2020.

5device types registered with the FDA
4510(k) clearances

Registration

FDA registration record for Anhui Intco Medical Products Co., Ltd.
Registered name ANHUI INTCO MEDICAL PRODUCTS CO., LTD.
Status Registered
Registration expires 2026
Registration number 3017610877
FEI number 3017610877
Establishment type Contract manufacturer, Manufacturer

Chinese Registration

Chinese company register details for Anhui Intco Medical Products Co., Ltd.
Chinese legal name 安徽英科医疗用品有限公司
Source customs registration record

Location

Address of Anhui Intco Medical Products Co., Ltd.
City Huaibei
Province Anhui
Address No.6 Haitang South Road, Suixi Wuhu Modern Industrial Park
Postal code 235100
Country China

What It Makes

Device types Anhui Intco Medical Products Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Fentanyl And Other Opioid Protection Glove Class 1 Nitrile Examination Glove 3.5 , Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Synthetic Nitrile Patient Examination Gloves, Powder Free, and Tested for Use with Chemotherapy Drugs 2024 29
Medical Glove, Specialty Class 1 Nitrile Examination Glove 3.5 , Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Synthetic Nitrile Patient Examination Gloves, Powder Free, and Tested for Use with Chemotherapy Drugs 2020 48
Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs Class 1 Nitrile Examination Glove 3.5 , Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Synthetic Nitrile Patient Examination Gloves, Powder Free, and Tested for Use with Chemotherapy Drugs 2024 32
Polymer Patient Examination Glove Class 1 Nitrile Examination Glove 3.5 , Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Nitrile Patient Examination Gloves, Powder Free, Synthetic Nitrile Patient Examination Gloves, Powder Free, and Tested for Use with Chemotherapy Drugs 2020 83
Vinyl Patient Examination Glove Class 1 Patient Vinyl Examination Gloves, Powder Free, Non-Sterile 2020 72

Clearances

4 clearances name Anhui Intco Medical Products Co., Ltd. as applicant. 3 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.

510(k) clearances naming Anhui Intco Medical Products Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K231365 2024-03-01 LZA Traditional This company
K233598 2024-01-26 LZA Traditional This company
K191092 2019-07-22 LYZ Traditional This company
K190095 2019-06-20 LYZ Traditional This company
K240021 2024-04-08 LZA Traditional YUE Kang Anhui Medical Products Co., Ltd.
K222103 2023-08-24 LZA Traditional Shandong Yinghng Medical Products Co., Ltd.
K200093 2020-08-20 LZA Traditional Anhui Lntco Medical Products Co., Ltd.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Anhui Intco Medical Products Co., Ltd.
Employees 13,000+
Main products Disposable gloves, Protective apparel and gowns, Rehabilitation equipment, Physical therapy products, Personal care products
Certifications Multiple (see certifications page)
Export markets 150+ countries and regions
OEM and ODM Offered

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer