Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IndonesiaLabelled 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 PT Smartglove Indonesia with 12 510(k) clearances. The most recent is a 510(k) clearance dated Jul 18, 2014: POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES.
| Jul 18, 2014 | POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVESK133699 · LZA | 510(k) clearances |
| Sep 7, 2010 | POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUEK101630 · LZA | 510(k) clearances |
| Jul 1, 2010 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)K101293 · LZA | 510(k) clearances |
| Oct 19, 2009 | POWDER FREE NITRILE EXAMINATION GLOVES, BLACKK092034 · LZA | 510(k) clearances |
| Aug 20, 2004 | POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLORK041848 · LZA | 510(k) clearances |
| Aug 12, 2004 | POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)K040792 · LYY | 510(k) clearances |
| Jun 3, 2004 | POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)K040791 · LZA | 510(k) clearances |
| Mar 25, 2003 | POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)K030284 · LZA | 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
