Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015219124

FEI Number

3015219124

Entity Name

I QUALITY RUBBER INDUSTRIES SDN. BHD.

City/State/Country

Matang Perak, MY

Establishment Address

Lot 6860, Jalan Matang, Matang Perak 34750, MY

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

I Quality Rubber Industries Sdn. Bhd. (Owner Number: 10059753)

Owner / Operator Contact Address

Lot 6860, Jalan Matang, Matang, MY-08 34750, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K002065

PMA Number

N/A

All Registered Proprietary Names

Latex patient examination glove Powder Free Latex (Pink) Examination Gloves Polymer patient examination glove Powder Free Nitrile (Dark Blue) Examination Gloves Polymer patient examination glove Powder Free Nitrile (Black) Examination Gloves Polymer patient examination glove Powder Free Nitrile (Blue and White) Examination Gloves Polymer patient examination glove Powder Free Nitrile (Orange) Examination Gloves Polymer patient examination glove Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs Label Latex patient examination glove Comfort PowderFree Latex Examination Gloves with Protein Content Labelling Claim Latex patient examination glove - Latex, Examination Gloves, Polymer Coated, Powder-Free, Contains 50 Micrograms

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2019-02-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-02-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-02-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-02-19
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-02-20
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2019-02-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-02-20
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2019-02-19
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2019-02-19

Official Correspondent

LEONG CHOI LING

US Agent Details

TERRELL CUNNINGHAM Business: T. Cunningham Consulting & Associates, LLC Email: cunninghamterrella@gmail.com Phone: (301) 5359600

Related Public Records

Same Entity

I Quality Rubber Industries Sdn. Bhd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K894452	Kerala Rubber & Reclaims, Ltd.	KRR GLOVE, PATIENT EXAMINATION GLOVES	1989-08-09
K891323	Li Wah-Hong Kong, Inc.	LI WAH LATEX EXAMINATION GLOVES	1989-08-31
K891418	C & K Mfg. & Sales Co.	LATEX EXAMINATION GLOVES, STYLE 510 LX	1989-06-22
K994255	Pt. Maja Agung Latexindo	LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE	2000-02-07
K892946	Yeou-Fwu Rubber Industrial Co., Ltd.	STERILE PATIENT EXAMINATION GLOVES	1989-08-10

Similar Registrations

Registration Number	Establishment Name	Location
3017940518	STAR INVESTMENT AND TRADE JOINT STOCK COMPANY	Bac Ninh, VN
1000266564	SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED.	Hat Yai Songkhla, TH
8040653	ARISTA LATINDO INDUSTRIAL, LTD. P.T.	JAKARTA BARAT, ID
3002661124	ULINE, INC.	Pleasant Prairie, WI, US
3019769825	HARTALEGA NGC SDN. BHD. (LOT 39496)	Sepang Selangor, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015219124. Last updated year: 2026. Please use registration number 3015219124 when referencing this establishment in official correspondence.