Data / Medical devices / Malaysia / Comfort Rubber Gloves Industries Sdn Bhd
Comfort Rubber Gloves Industries Sdn Bhd: FDA-registered device maker in TAIPING Perak, Malaysia, 12 510(k) clearances
Comfort Rubber Gloves Industries Sdn Bhd is registered with the FDA (registration 3005568780) in TAIPING Perak, Malaysia. It lists 4 device types. The FDA files 12 510(k) clearances under its listings, the newest dated April 29, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005568780
- FEI number
- 3003116055
- Address
- Lot 821, Jalan Matang Matang, TAIPING Perak, Malaysia, 34750
- Owner or operator
- COMFORT RUBBER GLOVES INDUSTRIES SDN BHD (9008127)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- February 6, 2006
- Registered through
- 2026
- Brand names listed
- Black Colored, Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, LATEX EXAMINATION GLOVES, NITRILE EXAMINATIONGLOVES, NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY, Olivia Claire Health, Powder Free NItrile Examination Gloves Tested For Use with Chemotherapy Drugs Labeling Claim, Powder Free Natural Rubber Latex Examination Gloves- Blue, Non-Sterile and Protein Claim of 50mg/dm2 or Less Protein, Powder Free Nitrile Examination Gloves (Orange) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 29, 2025 | K250069 | Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein | LYY | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| June 19, 2020 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| April 15, 2020 | K200181 | Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| June 27, 2019 | K190080 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) | LZA | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| May 15, 2018 | K180476 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| September 20, 2017 | K171541 | Powder Free Nitrile Examination Gloves (Orange) | LZA | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| March 28, 2017 | K162405 | 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) | LZA | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| June 15, 2011 | K110297 | POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES | LZA | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| February 10, 2009 | K083624 | POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES | LZA | Substantially Equivalent | Comfort Rubber Gloves Ind. Sdn. Bhd. | accessdata.fda.gov |
| November 13, 2003 | K032444 | NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY | LZC | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| August 22, 2000 | K002065 | PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR | LYY | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| April 23, 1998 | K974424 | COMFORT RUBBER GLOVES INDUSTRIES SDN BHD | LYY | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
Updated April 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.