# P.T. Irama Dinamika Latex

- Location (FDA's records): Indonesia, ID
- FDA decisions: 11 (1991–1999): 11 510(k) clearances
- Product codes: LYY (7), LZA (4)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K984449: Natural Rubber Pre-Powdered Colored & Flavored Patient Examination Gloves with Protein Labelling Claim (Mar 19, 1999)
- K981064: Powderfree Colored and Flavored Chloroprene Patient Examination Gloves (Nov 5, 1998)
- K980848: Hypoallergenic Latex Patient Exam Gloves-Prepowdered (Apr 28, 1998)
- K972306: Powderfree Colored and Flavored Nitrile Copolymer Patient Examination Gloves-Medical Device (Sep 12, 1997)
- K965155: Latex Exam Gloves (Mar 5, 1997)
- K962518: Nitrile Copolymer Patient Examination Gloves (Dec 19, 1996)
- K963771: Chloroprene Exam Gloves (Dec 19, 1996)
- K960315: Flavored Latex Patient Examination (Nov 20, 1996)

Source page: https://510kreport.com/company/pt-irama-dinamika-latex