Hebei Handform Medical Products Co., Ltd.
Registered establishment in Xingtai, Hebei, China. 1 device type.
Hebei Handform Medical Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Vinyl Patient Examination Glove. Its earliest product listing with the FDA dates from 2010.
Registration
| Registered name | HEBEI HANDFORM MEDICAL PRODUCTS CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008388240 |
| FEI number | 3008388240 |
| Establishment type | Manufacturer |
Location
| City | Xingtai |
|---|---|
| Province | Hebei |
| Address | Julu County industrial park |
| Postal code | 055250 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Vinyl Patient Examination Glove | Class 1 | Vinyl patient examination glove, Clear Vinyl Examination Gloves Mediglove Brand, Yellow Stretch Vinyl Examination Gloves Mediglove Brand, Vinyl examination gloves yellow, White Vinyl Exam Gloves Powder-free | 2010 | 72 |
Clearances
No clearance names Hebei Handform Medical Products Co., Ltd. as applicant. 4 are held by another company 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 |
|---|---|---|---|---|
| K101358 | 2010-08-24 | LYZ | Traditional | Hebei Handform Plastic Products Co., Ltd. |
| K101362 | 2010-06-17 | LYZ | Traditional | Hebei Handform Plastic Products Co., Ltd. |
| K082690 | 2009-02-09 | LYZ | Traditional | Hebei Handform Plastic Products Co., Ltd. |
| K082691 | 2009-02-04 | LYZ | Traditional | Hebei Handform Plastic Products Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Main products | Disposable vinyl gloves, Nitrile gloves, Nitrile compound gloves |
| Certifications | ISO9001, ISO13485, HACCP, GMP, CE, FDA, NSF, ASTM |
| Export markets | USA, Europe, Japan, many other countries |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Hebei Lufen Tech Co., Limited | 12 |
| Ningjin Runboda Medical Protective Products Co., Ltd. | 8 |
| Kimlead Hygiene Products (Hebei) Co., Ltd. | 5 |
| Hebei Titans Hongsen Medical Technology Co., Ltd. | 3 |
| Hebei Grandeast Plastic Products Co Ltd | 1 |
| Hebei Hongtai Plastic Products Co., Ltd. | 1 |
| Hebei Changsheng Plastic Products Co., Ltd. | 1 |
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.