P.T. Irama Dinamika Latex
Medan - Indonesia, ID
P.T. Irama Dinamika Latex appears in FDA device records in Medan - Indonesia, ID. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for P.T. Irama Dinamika Latex between 1991 and 1999. The busiest year on record is 1996, with 4. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1994 | 1 |
| 1996 | 4 |
| 1997 | 2 |
| 1998 | 2 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K984449 | NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM | LYY | Substantially Equivalent | |
| K981064 | POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K980848 | HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED | LYY | Substantially Equivalent | |
| K972306 | POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE | LZA | Substantially Equivalent | |
| K965155 | LATEX EXAM GLOVES | LYY | Substantially Equivalent | |
| K963771 | CHLOROPRENE EXAM GLOVES | LZA | Substantially Equivalent | |
| K962518 | NITRILE COPOLYMER PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K960315 | FLAVORED LATEX PATIENT EXAMINATION | LYY | Substantially Equivalent | |
| K953462 | PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K941787 | LATEX EXAM GLOVES | LYY | Substantially Equivalent | |
| K913776 | PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain