Kossan Latex Industries (M) Sdn Bhd
KLANG Selangor, MY
KOSSAN LATEX INDUSTRIES (M) SDN BHD appears in FDA device records in KLANG Selangor, MY. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Kossan Latex Industries (M) Sdn Bhd between 1989 and 2013. The busiest year on record is 1998, with 4. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1997 | 2 |
| 1998 | 4 |
| 1999 | 2 |
| 2000 | 2 |
| 2002 | 1 |
| 2006 | 3 |
| 2007 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K123749 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE | LZA | Substantially Equivalent | |
| K120066 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL | LZA | Substantially Equivalent | |
| K111772 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE | LZA | Substantially Equivalent | |
| K062764 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED | LZC | Substantially Equivalent | |
| K062965 | CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM | LYY | Substantially Equivalent | |
| K060775 | POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF | LYY | Substantially Equivalent | |
| K060771 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED | LZA | Substantially Equivalent | |
| K024025 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR | LZA | Substantially Equivalent | |
| K001557 | LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K001190 | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE | LYY | Substantially Equivalent | |
| K992497 | POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) | LZA | Substantially Equivalent | |
| K992496 | POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) | LZA | Substantially Equivalent | |
| K984020 | POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K984019 | POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K983723 | CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K983721 | POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K970222 | LOW PROTEIN LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K964826 | POWDER - FREE LATEX EXAMINATION GLOVES APPLICATION | LYY | Substantially Equivalent | |
| K891417 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005632797 | 3005632797 | KOSSAN LATEX INDUSTRIES (M) SDN BHD | LOT 6129,JALAN HAJI ABDUL MANAN, KLANG Selangor 41050 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain