Data / Medical devices / China / Grand Work Plastic Products Co., Ltd.
Grand Work Plastic Products Co., Ltd.: FDA-registered device maker in ZANHUANG Hebei, China, 9 510(k) clearances
Grand Work Plastic Products Co., Ltd. is registered with the FDA (registration 3004168786) in ZANHUANG Hebei, China. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 9, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004168786
- Address
- Donggao Industrial Zone, ZANHUANG Hebei, China, 050000
- Owner or operator
- GRAND WORK PLASTIC PRODUCTS CO., LTD. (9058864)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 27, 2007
- Registered through
- 2026
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 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| August 9, 2023 | K232039 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Grand Work Plastic Products Co., Ltd. | accessdata.fda.gov |
| May 26, 2022 | K220249 | Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) | LZA | Substantially Equivalent | Grand Work Plastic Products Co., Ltd. | accessdata.fda.gov |
| May 11, 2022 | K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Grand Work Plastic Products Co., Ltd. | accessdata.fda.gov |
| December 5, 2014 | K142409 | Vinyl Co-Polymer Powder Free Examination Gloves | LYZ | Substantially Equivalent | Grand Work Plastic Products Co., Ltd. | accessdata.fda.gov |
| October 6, 2010 | K102089 | GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Grand Work Plastic Products Co., Ltd. | accessdata.fda.gov |
| November 17, 2004 | K042830 | POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES | LYZ | Substantially Equivalent | Grand Work Plastic Products Co., Ltd. | accessdata.fda.gov |
| July 28, 2004 | K040682 | SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE | LYZ | Substantially Equivalent | Grand Work Plastic Products Co., Ltd. | accessdata.fda.gov |
| June 3, 2004 | K040681 | SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE | LYZ | Substantially Equivalent | Grand Work Plastic Products Co., Ltd. | accessdata.fda.gov |
| April 27, 2004 | K040702 | SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE | LYZ | Substantially Equivalent | Grand Work Plastic 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 August 9, 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.