Data / Medical devices / Malaysia / Kossan Latex Industries (M) Sdn Bhd
Kossan Latex Industries (M) Sdn Bhd: FDA-registered device maker in KLANG Selangor, Malaysia, 7 510(k) clearances
Kossan Latex Industries (M) Sdn Bhd is registered with the FDA (registration 3005632797) in KLANG Selangor, Malaysia. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 20, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005632797
- Address
- LOT 6129,JALAN HAJI ABDUL MANAN Batu 5 1/4, JALAN MERU, KLANG Selangor, Malaysia, 41050
- Owner or operator
- KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (8040735)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 3, 2008
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| October 20, 2011 | K111772 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE | LZA | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | accessdata.fda.gov |
| February 27, 2007 | K062764 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED | LZC | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | accessdata.fda.gov |
| December 22, 2006 | K062965 | CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM | LYY | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | accessdata.fda.gov |
| May 16, 2006 | K060775 | POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF | LYY | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | accessdata.fda.gov |
| May 1, 2006 | K060771 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED | LZA | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | accessdata.fda.gov |
| May 23, 2000 | K001190 | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE | LYY | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | accessdata.fda.gov |
| December 7, 1998 | K983721 | POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE | LYY | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated October 20, 2011. 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.