Kossan Latex Industries(M)Sdn Bhd: FDA clearances and approvals
Kossan Latex Industries(M)Sdn Bhd has 19 FDA 510(k) clearances (first 1989, latest 2013), across 3 product codes in 1 review panel. Median 510(k) review time: 46 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 312 |
| 2013 | 1 | 85 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 11 | 11 |
| LZA | Polymer Patient Examination Glove | 7 | 7 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (19)
Most recent Kossan Latex Industries(M)Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123749 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE | LZA | 2013-03-01 | 85 |
| K120066 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL | LZA | 2012-11-16 | 312 |
| K111772 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE | LZA | 2011-10-20 | 119 |
| K062764 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED | LZC | 2007-02-27 | 165 |
| K062965 | CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM | LYY | 2006-12-22 | 84 |
| K060775 | POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF | LYY | 2006-05-16 | 55 |
| K060771 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED | LZA | 2006-05-01 | 40 |
| K024025 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR | LZA | 2002-12-18 | 12 |
| K001557 | LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) | LYY | 2000-06-09 | 21 |
| K001190 | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE | LYY | 2000-05-23 | 41 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kossan Latex Industries(M)Sdn Bhd.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Kossan Latex Industries(M)Sdn Bhd have?
Kossan Latex Industries(M)Sdn Bhd has 19 FDA 510(k) clearances (first 1989, latest 2013), across 3 product codes in 1 review panel.
How long does FDA take to clear Kossan Latex Industries(M)Sdn Bhd's 510(k)s?
The median time from FDA receipt to decision across Kossan Latex Industries(M)Sdn Bhd's cleared 510(k)s is 46 days.
What devices does Kossan Latex Industries(M)Sdn Bhd make?
Its most frequent FDA product codes are LYY (Latex Patient Examination Glove, 11); LZA (Polymer Patient Examination Glove, 7); LZC (Medical Glove, Specialty, 1).
Has Kossan Latex Industries(M)Sdn Bhd had device recalls?
openFDA lists no recalls under a recalling firm name matching Kossan Latex Industries(M)Sdn Bhd. Related entities may recall under other names.
Next steps
- See all 19 Kossan Latex Industries(M)Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Kossan Latex Industries(M)Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.