Data / Medical devices / Malaysia / I Quality Rubber Industries Sdn. Bhd.
I Quality Rubber Industries Sdn. Bhd.: FDA-registered device maker in Matang Perak, Malaysia, 10 510(k) clearances
I Quality Rubber Industries Sdn. Bhd. is registered with the FDA (registration 3015219124) in Matang Perak, Malaysia. It lists 3 device types. The FDA files 10 510(k) clearances under its listings, the newest dated May 15, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015219124
- Address
- Lot 6860, Jalan Matang, Matang Perak, Malaysia, 34750
- Owner or operator
- I Quality Rubber Industries Sdn. Bhd. (10059753)
- Roles
- Specification developer
- First device listed
- February 19, 2019
- Registered through
- 2026
- Brand names listed
- Latex patient examination glove - Latex, Examination Gloves, Polymer Coated, Powder-Free, Contains 50 Micrograms, Latex patient examination glove Comfort Latex Powdered Patient Examination Gloves with Protein Label Claim, Latex patient examination glove Comfort PowderFree Latex Examination Gloves with Protein Content Labelling Claim, Latex patient examination glove Powder Free Latex (Pink) 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 (Dark Blue) Examination Gloves, Polymer patient examination glove Powder Free Nitrile (Orange) Examination Gloves and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| 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 |
| October 29, 2010 | K101917 | COMFORT RUBBER GLOVES IND.SDN.BHD. | LYY | Substantially Equivalent | Comfort Rubber Gloves Industries Sdn. Bhd. | accessdata.fda.gov |
| November 27, 2009 | K092160 | POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES | LZA | Substantially Equivalent | Comfort Rubber Gloves Ind. 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 |
| 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 |
| May 23, 2000 | K001042 | COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE | 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 Polymer Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Medical Glove, Specialty
Updated May 15, 2018. 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.