Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kossan Latex Industries(M)Sdn Bhd · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
204 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123749 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-S | Kossan Latex Industries(M)Sdn Bhd | 2013-03-01 | 85 | 0 |
| K120066 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE A | Kossan Latex Industries(M)Sdn Bhd | 2012-11-16 | 312 | 0 |
| K111772 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED | Kossan Latex Industries(M)Sdn Bhd | 2011-10-20 | 119 | 0 |
| K062764 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-CO | Kossan Latex Industries(M)Sdn Bhd | 2007-02-27 | 165 | 0 |
| K062965 | CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GL | Kossan Latex Industries(M)Sdn Bhd | 2006-12-22 | 84 | 0 |
| K060775 | POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE | Kossan Latex Industries(M)Sdn Bhd | 2006-05-16 | 55 | 0 |
| K060771 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COL | Kossan Latex Industries(M)Sdn Bhd | 2006-05-01 | 40 | 0 |
| K024025 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR | Kossan Latex Industries(M)Sdn Bhd | 2002-12-18 | 12 | 0 |
| K001557 | LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAI | Kossan Latex Industries(M)Sdn Bhd | 2000-06-09 | 21 | 0 |
| K001190 | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS | Kossan Latex Industries(M)Sdn Bhd | 2000-05-23 | 41 | 0 |
| K992496 | POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-CO | Kossan Latex Industries(M)Sdn Bhd | 1999-08-25 | 30 | 0 |
| K992497 | POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLOR | Kossan Latex Industries(M)Sdn Bhd | 1999-08-25 | 30 | 0 |
| K984019 | POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CO | Kossan Latex Industries(M)Sdn Bhd | 1998-12-23 | 41 | 0 |
| K984020 | POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELI | Kossan Latex Industries(M)Sdn Bhd | 1998-12-23 | 41 | 0 |
| K983721 | POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE | Kossan Latex Industries(M)Sdn Bhd | 1998-12-07 | 46 | 0 |
| K983723 | CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION G | Kossan Latex Industries(M)Sdn Bhd | 1998-12-07 | 46 | 0 |
| K964826 | POWDER - FREE LATEX EXAMINATION GLOVES APPLICATION | Kossan Latex Industries(M)Sdn Bhd | 1997-06-24 | 204 | 0 |
| K970222 | LOW PROTEIN LATEX EXAMINATION GLOVES | Kossan Latex Industries(M)Sdn Bhd | 1997-06-24 | 154 | 0 |
| K891417 | PATIENT EXAMINATION GLOVES (LATEX) | Kossan Latex Industries(M)Sdn Bhd | 1989-05-12 | 59 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda