Maxter Glove Manufacturing Sdn Bhd
⚠️ Moderate Risk
FEI: 3003699698 • Selangor • MALAYSIA
FEI Number
3003699698
Location
Selangor
Country
MALAYSIAAddress
Lot 6070, Jalan Haji Abdul Manan,, 6th Miles Off Jalan, Meru, Klang, Selangor, , Malaysia
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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
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.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/6/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 3/26/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 11/17/2023 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Northern Border Imports (DNBI) | |
| 11/17/2023 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Northern Border Imports (DNBI) | |
| 3/31/2010 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | New York District Office (NYK-DO) |
| 10/4/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Southwest Import District Office (SWI-DO) | |
| 10/4/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Southwest Import District Office (SWI-DO) | |
| 3/26/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Maxter Glove Manufacturing Sdn Bhd's FDA import refusal history?
Maxter Glove Manufacturing Sdn Bhd (FEI: 3003699698) has 8 FDA import refusal record(s) in our database, spanning from 3/26/2007 to 5/6/2024.
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. Maxter Glove Manufacturing Sdn Bhd's FEI number is 3003699698.
What types of violations has Maxter Glove Manufacturing Sdn Bhd received?
Maxter Glove Manufacturing Sdn Bhd has been cited for 6 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 Maxter Glove Manufacturing Sdn Bhd come from?
All FDA import refusal data for Maxter Glove Manufacturing 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.