Top Glove (Zhangjigang) Co., Ltd.
⚠️ Moderate Risk
FEI: 3003994600 • Suzhou, Jiangsu • CHINA
FEI Number
3003994600
Location
Suzhou, Jiangsu
Country
CHINAAddress
53 Yi Alley, , 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.
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/10/2014 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 12/8/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 12/8/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 12/8/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 12/8/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 7/31/2007 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southeast Imports (DSEI) | |
| 6/13/2007 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/8/2007 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
| 6/16/2005 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
| 5/23/2005 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New York District Office (NYK-DO) |
| 5/23/2005 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New York District Office (NYK-DO) |
| 5/23/2005 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New York District Office (NYK-DO) |
| 5/23/2005 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Top Glove (Zhangjigang) Co., Ltd.'s FDA import refusal history?
Top Glove (Zhangjigang) Co., Ltd. (FEI: 3003994600) has 13 FDA import refusal record(s) in our database, spanning from 5/23/2005 to 2/10/2014.
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. Top Glove (Zhangjigang) Co., Ltd.'s FEI number is 3003994600.
What types of violations has Top Glove (Zhangjigang) Co., Ltd. received?
Top Glove (Zhangjigang) Co., Ltd. has been cited for 4 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 Top Glove (Zhangjigang) Co., Ltd. come from?
All FDA import refusal data for Top Glove (Zhangjigang) 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.