ZHIDA GLOVE CO.,LTD
⚠️ High Risk
FEI: 3011574374 • TANGSHAN, HEBEI • CHINA
FEI Number
3011574374
Location
TANGSHAN, HEBEI
Country
CHINAAddress
TANGGANG ROAD ,PACHIGANG TOWN, , TANGSHAN, HEBEI, 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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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 |
|---|---|---|---|
| 3/20/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 126FAILS STD | Division of Northern Border Imports (DNBI) |
| 3/20/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 126FAILS STD | Division of Northern Border Imports (DNBI) |
| 3/20/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 126FAILS STD | Division of Northern Border Imports (DNBI) |
| 3/20/2025 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 126FAILS STD | Division of Northern Border Imports (DNBI) |
| 10/4/2023 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is ZHIDA GLOVE CO.,LTD's FDA import refusal history?
ZHIDA GLOVE CO.,LTD (FEI: 3011574374) has 5 FDA import refusal record(s) in our database, spanning from 10/4/2023 to 3/20/2025.
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. ZHIDA GLOVE CO.,LTD's FEI number is 3011574374.
What types of violations has ZHIDA GLOVE CO.,LTD received?
ZHIDA GLOVE CO.,LTD has been cited for 2 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 ZHIDA GLOVE CO.,LTD come from?
All FDA import refusal data for ZHIDA 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.