Jiangsu Cureguard Glove Co., Ltd.
⚠️ High Risk
FEI: 3006534695 • Suqian, Jiangsu • CHINA
FEI Number
3006534695
Location
Suqian, Jiangsu
Country
CHINAAddress
No.65 Shenzhen Road,, THE ECONOMIC DEVELOPMENT ZONE OF SUQIAN, , Suqian, Jiangsu, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/6/2022 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 9/6/2022 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 9/6/2022 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 9/6/2022 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 9/6/2022 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 9/2/2022 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 9/2/2022 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 9/2/2022 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 8/26/2022 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 8/26/2022 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 7/26/2022 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 9/28/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Northern Border Imports (DNBI) | |
| 9/28/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Northern Border Imports (DNBI) | |
| 6/15/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 6/15/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 6/15/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 6/15/2017 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 7/22/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 7/22/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 7/22/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | San Francisco District Office (SAN-DO) |
| 7/8/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
| 6/27/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | San Francisco District Office (SAN-DO) |
| 6/25/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | San Francisco District Office (SAN-DO) |
| 6/7/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | San Francisco District Office (SAN-DO) |
| 6/7/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | San Francisco District Office (SAN-DO) |
| 6/7/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | San Francisco District Office (SAN-DO) |
| 6/7/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | San Francisco District Office (SAN-DO) |
| 5/7/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
| 2/22/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 2/22/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/8/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 7/8/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 7/8/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 3/18/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 223FALSE | New Orleans District Office (NOL-DO) |
| 2/10/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 2/10/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 11/13/2008 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Jiangsu Cureguard Glove Co., Ltd.'s FDA import refusal history?
Jiangsu Cureguard Glove Co., Ltd. (FEI: 3006534695) has 37 FDA import refusal record(s) in our database, spanning from 11/13/2008 to 9/6/2022.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Jiangsu Cureguard Glove Co., Ltd.'s FEI number is 3006534695.
What types of violations has Jiangsu Cureguard Glove Co., Ltd. received?
Jiangsu Cureguard Glove Co., Ltd. has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Jiangsu Cureguard Glove Co., Ltd. come from?
All FDA import refusal data for Jiangsu Cureguard Glove Co., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.