ImportRefusal LogoImportRefusal

AM Gloves Co Ltd

⚠️ Moderate Risk

FEI: 7912 • Shiang Tainan Hsien • TAIWAN

FEI

FEI Number

7912

📍

Location

Shiang Tainan Hsien

🇹🇼

Country

TAIWAN
🏢

Address

No. 50 Kong Yeh Road, Ur-Chen, Chuan, Kuan Tien, Shiang Tainan Hsien, , Taiwan

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
1
Unique Violations
3/31/2011
Latest Refusal
3/31/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

4773×

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

DateProductViolationsDivision
3/31/2011
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Los Angeles District Office (LOS-DO)
3/31/2011
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Los Angeles District Office (LOS-DO)
3/31/2011
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is AM Gloves Co Ltd's FDA import refusal history?

AM Gloves Co Ltd (FEI: 7912) has 3 FDA import refusal record(s) in our database, spanning from 3/31/2011 to 3/31/2011.

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. AM Gloves Co Ltd's FEI number is 7912.

What types of violations has AM Gloves Co Ltd received?

AM Gloves Co Ltd 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 AM Gloves Co Ltd come from?

All FDA import refusal data for AM Gloves 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.