Data / Medical devices / China / Jiangsu Cureguard Glove Co., Ltd.
Jiangsu Cureguard Glove Co., Ltd.: FDA-registered device maker in Ulanqab City Inner Mongolia, China, 11 510(k) clearances
Jiangsu Cureguard Glove Co., Ltd. is registered with the FDA (registration 3006534695) in Ulanqab City Inner Mongolia, China. It lists 3 device types. The FDA files 11 510(k) clearances under its listings, the newest dated October 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006534695
- Address
- Add1: NO.65, Shenzhen Road, The Economic Development Zone, Suqian City, Jiangsu Province, 223800,P. R. China. Add2: North of Pingsai St. and east of Guihua Rd, Yiwutang Industrial Park, Chahar High-Tech Development Zone, Ulanqab City Inner Mongolia, China, 012209
- Owner or operator
- JIANGSU CUREGUARD GLOVE CO., LTD. (9096440)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- April 6, 2007
- Registered through
- 2026
- Brand names listed
- Disposable Nitrile Examination Glove (Black/ Lilac/ Navy Blue/Burgundy), Disposable Nitrile Examination Glove (Fuchsia/Cool Gray/Green/Rose Gold), Disposable Nitrile Medical Examination Glove, Disposable Nitrile Medical Examination Glove (Tested For Use With Chemotherapy Drugs), Disposable Synthetic Vinyl Nitrile Examination Glove, FifthPulse Medical Examination Nitrile Gloves Burgundy, FifthPulse Medical Examination Nitrile Gloves Lilac, FifthPulse Medical Examination Nitrile Gloves Navy Blue
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Complaint file establishment, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| October 1, 2022 | K222937 | Disposable Nitrile Examination Glove | LZA | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. | accessdata.fda.gov |
| March 15, 2022 | K213121 | Disposable Nitrile Examination Glove | LZA | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. | accessdata.fda.gov |
| August 8, 2021 | K211354 | Disposable Synthetic Vinyl Nitrile Examination Glove | LYZ | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. | accessdata.fda.gov |
| August 5, 2021 | K211608 | Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) | LZA | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. | accessdata.fda.gov |
| July 30, 2021 | K210691 | Disposable Nitrile Medical Examination Glove | LZA | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. | accessdata.fda.gov |
| July 20, 2021 | K210684 | Disposable Nitrile Medical Examination Glove | LZA | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. | accessdata.fda.gov |
| March 4, 2010 | K093576 | RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR | LYZ | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. | accessdata.fda.gov |
| August 20, 2008 | K081657 | POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) | LYZ | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. | accessdata.fda.gov |
| July 21, 2008 | K081655 | POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW) | LYZ | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. | accessdata.fda.gov |
| February 22, 2007 | K070076 | POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED) | LYZ | Substantially Equivalent | Jiangsu Cureguard Glove Co., Ltd. | accessdata.fda.gov |
| February 9, 2007 | K070075 | POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) | LYZ | Substantially Equivalent | Jiangsu Cureguard Glove 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
Updated October 1, 2022. 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.