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Supermax Latex Products Sdn Bhd

✅ Low Risk

FEI: 3002808252 • Sungai Buloh, Selangor • MALAYSIA

FEI

FEI Number

3002808252

📍

Location

Sungai Buloh, Selangor

🇲🇾

Country

MALAYSIA
🏢

Address

LOT 38 & 42, PUTRA INDUSTRIAL PARK, BUKIT RAHMAN PUTRA, Sungai Buloh, Selangor, Malaysia

Low Risk

FDA Import Risk Assessment

24.5
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

4
Total Refusals
2
Unique Violations
8/28/2008
Latest Refusal
5/14/2003
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
7.5×10%
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

3413×

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).

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
8/28/2008
80LYYGLOVE, PATIENT EXAMINATION, LATEX
341REGISTERED
Florida District Office (FLA-DO)
8/28/2008
80LYYGLOVE, PATIENT EXAMINATION, LATEX
341REGISTERED
Florida District Office (FLA-DO)
8/28/2008
80LYYGLOVE, PATIENT EXAMINATION, LATEX
341REGISTERED
Florida District Office (FLA-DO)
5/14/2003
80LZAGLOVE, PATIENT EXAMINATION, POLY
477HOLES
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Supermax Latex Products Sdn Bhd's FDA import refusal history?

Supermax Latex Products Sdn Bhd (FEI: 3002808252) has 4 FDA import refusal record(s) in our database, spanning from 5/14/2003 to 8/28/2008.

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. Supermax Latex Products Sdn Bhd's FEI number is 3002808252.

What types of violations has Supermax Latex Products Sdn Bhd received?

Supermax Latex Products Sdn Bhd 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 Supermax Latex Products Sdn Bhd come from?

All FDA import refusal data for Supermax Latex Products 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.