Kossan International Sdn Bhd: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Kossan International Sdn Bhd” (first 2015, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 132 days. Since 2017 the median was 130 days, against 114 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 104 |
| 2016 | 3 | 393 |
| 2017 | 1 | 151 |
| 2018 | 1 | 132 |
| 2019 | 3 | 81 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 98 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 156 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kossan International Sdn Bhd took a median 130 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 12 | 12 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (13)
Most recent Kossan International Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR | LZA | 2026-08-18 | 160 |
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid | LZA | 2026-01-13 | 153 |
| K232461 | Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis | LZA | 2023-11-14 | 91 |
| K230573 | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) | LYY | 2023-06-13 | 104 |
| K191800 | Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim | LZA | 2019-09-16 | 75 |
| K190606 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | LZA | 2019-05-28 | 81 |
| K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2019-04-05 | 130 |
| K181857 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2018-11-20 | 132 |
| K170397 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs | LZA | 2017-07-10 | 151 |
| K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile | LZA | 2016-08-03 | 401 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kossan International Sdn Bhd.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Kossan Latex Industries(M)Sdn Bhd (19 510(k)s)
- Kossan International Sdn Bhd3 (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kossan International Sdn Bhd?
FDA lists 13 510(k) clearances under the applicant name “Kossan International Sdn Bhd” (first 2015, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kossan International Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kossan International Sdn Bhd is 132 days. Since 2017: 130 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kossan International Sdn Bhd?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 12); LYY (Latex Patient Examination Glove, 1).
Next steps
- See all 13 Kossan International Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LZA, Kossan International Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.