Medical Device Manufacturer · MY , Matang

Comfort Rubber Gloves Industries Sdn. Bhd.

15 submissions · 15 cleared · Since 1994
15
Total
15
Cleared
0
Denied

Comfort Rubber Gloves Industries Sdn. Bhd. — FDA 510(k) Submissions

Comfort Rubber Gloves Industries Sdn. Bhd. has submitted 15 FDA 510(k) premarket notifications since 1994, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Polymer Patient Examination Glove, Latex Patient Examination Glove, Medical Glove, Specialty . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
Powder Free Natural Rubber Latex Examination Gloves ? Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
K250069 · LYY Latex Patient Examination... · General Hospital
Apr 2025 109d
Nitrile Powder Free Examination Gloves Biodegradable (Green)
K240269 · LZA Polymer Patient... · General Hospital
Oct 2024 268d
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
K241528 · LZA Polymer Patient... · General Hospital
Aug 2024 68d
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
K192954 · LZA Polymer Patient... · General Hospital
Jun 2020 242d
Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K200181 · LZA Polymer Patient... · General Hospital
Apr 2020 82d
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
K190080 · LZA Polymer Patient... · General Hospital
Jun 2019 162d
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
K180476 · LZC Medical Glove, Specialty · General Hospital
May 2018 82d
Powder Free Nitrile Examination Gloves (Orange)
K171541 · LZA Polymer Patient... · General Hospital
Sep 2017 117d
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)
K162405 · LZA Polymer Patient... · General Hospital
Mar 2017 211d
POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
K110297 · LZA Polymer Patient... · General Hospital
Jun 2011 134d
COMFORT RUBBER GLOVES IND.SDN.BHD.
K101917 · LYY Latex Patient Examination... · General Hospital
Oct 2010 112d
PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR
K002065 · LYY Latex Patient Examination... · General Hospital
Aug 2000 46d
COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE
K001042 · LYY Latex Patient Examination... · General Hospital
May 2000 53d
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
K974424 · LYY Latex Patient Examination... · General Hospital
Apr 1998 150d
PATIENT EXAMINATION GLOVES
K935256 · LYY Latex Patient Examination... · General Hospital
Mar 1994 128d
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