Grand Work Plastic Products Co., Ltd.
Manufacturer and brand owner in Zanhuang, Hebei, China. 5 device types, 2 products catalogued, 19 clearances.
Grand Work Plastic 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. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2007.
5device types registered with the FDA
2products catalogued under its own name
19510(k) clearances
Registration
| Registered name | GRAND WORK PLASTIC PRODUCTS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004168786 |
| FEI number | 3004168786 |
| DUNS | 527852220 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Zanhuang |
|---|---|
| Province | Hebei |
| Address | DONGGAO INDUSTRIAL ZONE |
| Postal code | 050000 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | Class 1 | 2022 | 29 |
| Medical Glove, Specialty | Class 1 | 2022 | 48 |
| Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs | Class 1 | 2020 | 32 |
| Polymer Patient Examination Glove | Class 1 | 2022 | 83 |
| Vinyl Patient Examination Glove | Class 1 | 2007 | 72 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232444 | 2023-12-20 | KGO | Traditional | This company |
| K232039 | 2023-08-09 | LZA | Special | This company |
| K230217 | 2023-05-13 | KGO | Traditional | This company |
| K222892 | 2022-12-15 | LZA | Traditional | This company |
| K213574 | 2022-07-12 | LZA | Traditional | This company |
| K220249 | 2022-05-26 | LZA | Traditional | This company |
| K220250 | 2022-05-11 | LZA | Traditional | This company |
| K220240 | 2022-03-31 | LYZ | Traditional | This company |
| K142409 | 2014-12-05 | LYZ | Traditional | This company |
| K102089 | 2010-10-06 | LYZ | Traditional | This company |
| K102094 | 2010-10-05 | LYZ | Traditional | This company |
| K061562 | 2006-07-11 | LYZ | Traditional | This company |
| K051662 | 2005-07-22 | LZA | Traditional | This company |
| K042830 | 2004-11-17 | LYZ | Traditional | This company |
| K040682 | 2004-07-28 | LYZ | Traditional | This company |
| K041225 | 2004-07-15 | LYZ | Traditional | This company |
| K040681 | 2004-06-03 | LYZ | Traditional | This company |
| K041188 | 2004-06-01 | LYZ | Traditional | This company |
| K040702 | 2004-04-27 | LYZ | Traditional | This company |
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.