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Metacure Surgical Gloves Sdn Bhd

⚠️ Moderate Risk

FEI: 3006308161 • Selangor Darul Ehban • MALAYSIA

FEI

FEI Number

3006308161

📍

Location

Selangor Darul Ehban

🇲🇾

Country

MALAYSIA
🏢

Address

No. 1 Jalan 203 Off Jalan Tandang46050, , Selangor Darul Ehban, , Malaysia

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/16/2010
Latest Refusal
3/16/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4771×

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
3/16/2010
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
New York District Office (NYK-DO)

Frequently Asked Questions

What is Metacure Surgical Gloves Sdn Bhd's FDA import refusal history?

Metacure Surgical Gloves Sdn Bhd (FEI: 3006308161) has 1 FDA import refusal record(s) in our database, spanning from 3/16/2010 to 3/16/2010.

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. Metacure Surgical Gloves Sdn Bhd's FEI number is 3006308161.

What types of violations has Metacure Surgical Gloves Sdn Bhd received?

Metacure Surgical Gloves Sdn Bhd 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 Metacure Surgical Gloves Sdn Bhd come from?

All FDA import refusal data for Metacure Surgical Gloves Sdn Bhd 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.