Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005568780

FEI Number

3003116055

Entity Name

COMFORT RUBBER GLOVES INDUSTRIES SDN BHD

City/State/Country

TAIPING Perak, MY

Establishment Address

LOT 821, JALAN MATANG, MATANG, TAIPING Perak 34750, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

COMFORT RUBBER GLOVES INDUSTRIES SDN BHD (Owner Number: 9008127)

Owner / Operator Contact Address

LOT 821, JALAN MATANG, MATANG, --, TAIPING, PERAK, MY-NOTA 34750, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K002065

PMA Number

N/A

All Registered Proprietary Names

Powder Free NItrile Examination Gloves Tested For Use with Chemotherapy Drugs Labeling Claim Olivia Claire Health Black Colored, Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Powder Free Natural Rubber Latex Examination Gloves- Blue, Non-Sterile and Protein Claim of 50mg/dm2 or Less Protein NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY Powder Free Nitrile Examination Gloves (Orange) Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labelling Claim (Black) LATEX EXAMINATION GLOVES Powder Free Nitrile Examination Gloves Tested For Use with Chemotherapy Drugs Labelling Claim (Green) Power Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl LATEX EXAMINATION GLOVES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-11-08
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-11-08
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-03-01
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-03-01
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2025-05-07
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-11-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-11-08
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-01-11
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2006-02-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-06-26
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2018-06-26
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2021-05-02
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-05-02
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-05-02
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2006-02-06

Official Correspondent

CHAN YEW MEN

US Agent Details

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

Related Public Records

Same Entity

COMFORT RUBBER GLOVES 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
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21
K101595	Better Care Plastic Technology Cp., Ltd.	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE	2010-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005568780. Last updated year: 2026. Please use registration number 3005568780 when referencing this establishment in official correspondence.