Great Glove (Xinghua) Incorporation
⚠️ Moderate Risk
FEI: 3005478020 • Suzhou, Jiangsu • CHINA
FEI Number
3005478020
Location
Suzhou, Jiangsu
Country
CHINAAddress
Floor 3-4, Huachang South Rd; Yangshezhen Zhangjiagang, Suzhou, Jiangsu, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/4/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Florida District Office (FLA-DO) |
| 1/13/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 1/13/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 12/18/2008 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 12/18/2008 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 7/16/2008 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
| 7/16/2008 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
| 7/16/2008 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Great Glove (Xinghua) Incorporation's FDA import refusal history?
Great Glove (Xinghua) Incorporation (FEI: 3005478020) has 8 FDA import refusal record(s) in our database, spanning from 7/16/2008 to 9/4/2009.
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. Great Glove (Xinghua) Incorporation's FEI number is 3005478020.
What types of violations has Great Glove (Xinghua) Incorporation received?
Great Glove (Xinghua) Incorporation has been cited for 1 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 Great Glove (Xinghua) Incorporation come from?
All FDA import refusal data for Great Glove (Xinghua) Incorporation 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.