Comfort Rubber Gloves Industries Sdn. Bhd. is one of 78 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Comfort Rubber Gloves Industries Sdn. Bhd. - FDA 510(k) Cleared Devic...
Recent clearances: Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein, Nitrile Powder Free Examination Gloves Biodegradable (Green), Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
15
Total
15
Cleared
0
Denied
Comfort Rubber Gloves Industries Sdn. Bhd., manufactures examination gloves for healthcare settings. The company operates with a manufacturing facility in Matang, Malaysia.
The company has received 15 FDA 510(k) clearances from 15 total submissions since 1994. All submissions focus on General Hospital devices. The latest clearance was granted in 2025, confirming active regulatory engagement.
Product specialization centers on powder-free examination gloves in multiple materials and colors. Recent cleared devices include nitrile and natural rubber latex formulations. Many products are tested for compatibility with chemotherapy drugs and feature low dermatitis potential claims.
Explore the complete regulatory record, including device names, product codes, and clearance dates in the 510(k) database.
510(k) submissions have been managed by T. Cunningham Consulting & Associates, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Comfort Rubber Gloves Industries Sdn. Bhd.
15 devices
Cleared
Apr 29, 2025
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and...
General Hospital
109d
Cleared
Oct 25, 2024
Nitrile Powder Free Examination Gloves Biodegradable (Green)
General Hospital
268d
Cleared
Aug 06, 2024
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis...
General Hospital
68d
Cleared
Jun 19, 2020
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs...
General Hospital
242d
Cleared
Apr 15, 2020
Black Colored Powder Free Nitrile Examination Gloves Tested for Use with...
General Hospital
82d
Cleared
Jun 27, 2019
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs...
General Hospital
162d
Cleared
May 15, 2018
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
General Hospital
82d
Cleared
Sep 20, 2017
Powder Free Nitrile Examination Gloves (Orange)
General Hospital
117d
Cleared
Mar 28, 2017
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs...
General Hospital
211d
Cleared
Jun 15, 2011
POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
General Hospital
134d
Cleared
Oct 29, 2010
COMFORT RUBBER GLOVES IND.SDN.BHD.
General Hospital
112d
Cleared
Aug 22, 2000
PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR...
General Hospital
46d
Cleared
May 23, 2000
COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM...
General Hospital
53d
Cleared
Apr 23, 1998
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
General Hospital
150d
Cleared
Mar 09, 1994
PATIENT EXAMINATION GLOVES
General Hospital
128d