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 14, 2026, FDA's public records list Ultrawin Sdn Bhd with 5 510(k) clearances. The most recent is a 510(k) clearance dated Jul 28, 2009: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES.
| Jul 28, 2009 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVESK090828 · LZA | 510(k) clearances |
| Feb 29, 2008 | SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVEK072802 · LYY | 510(k) clearances |
| Sep 24, 1999 | EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATEDK992175 · LYY | 510(k) clearances |
| Oct 13, 1998 | EXTRA-CARE POWDER-FREE EXAMINATION GLOVEK983175 · LYY | 510(k) clearances |
| Mar 11, 1992 | ULTRASAFEK920059 · 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
