Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in MalaysiaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Koon Seng Sdn Bhd with 7 510(k) clearances. The most recent is a 510(k) clearance dated Dec 21, 2021: Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Dru….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 21, 2021 | Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)K212613 · LZA | 510(k) clearances |
| Feb 22, 2018 | KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)K171171 · LZA | 510(k) clearances |
| Jul 14, 2011 | ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREEK110960 · LZA | 510(k) clearances |
| Dec 2, 2009 | KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)K093375 · LYY | 510(k) clearances |
| Dec 7, 2001 | ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)K013537 · LYY | 510(k) clearances |
| Oct 31, 2001 | ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS ORK012714 · LYY | 510(k) clearances |
| May 31, 1989 | PATIENT EXAMINATION GLOVES (LATEX)K891821 · LYY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
