P.T. Irama Dinamika Latex: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “P.T. Irama Dinamika Latex” (first 1991, latest 1999), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 95 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 7 | 7 |
| LZA | Polymer Patient Examination Glove | 4 | 4 |
Review panels
- General Hospital (11)
Most recent P.T. Irama Dinamika Latex 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984449 | NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM | LYY | 1999-03-19 | 95 |
| K981064 | POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | 1998-11-05 | 227 |
| K980848 | HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED | LYY | 1998-04-28 | 55 |
| K972306 | POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE | LZA | 1997-09-12 | 85 |
| K965155 | LATEX EXAM GLOVES | LYY | 1997-03-05 | 72 |
| K963771 | CHLOROPRENE EXAM GLOVES | LZA | 1996-12-19 | 91 |
| K962518 | NITRILE COPOLYMER PATIENT EXAMINATION GLOVES | LZA | 1996-12-19 | 175 |
| K960315 | FLAVORED LATEX PATIENT EXAMINATION | LYY | 1996-11-20 | 302 |
| K953462 | PATIENT EXAMINATION GLOVES | LYY | 1996-01-04 | 164 |
| K941787 | LATEX EXAM GLOVES | LYY | 1994-10-19 | 191 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named P.T. Irama Dinamika Latex.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under P.T. Irama Dinamika Latex?
FDA lists 11 510(k) clearances under the applicant name “P.T. Irama Dinamika Latex” (first 1991, latest 1999), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by P.T. Irama Dinamika Latex?
The median time from FDA receipt to decision across 510(k)s cleared under the name P.T. Irama Dinamika Latex is 95 days.
Which FDA product codes appear under P.T. Irama Dinamika Latex?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 7); LZA (Polymer Patient Examination Glove, 4).
Next steps
- See all 11 P.T. Irama Dinamika Latex clearances with predicates and recalls
- Run predicate analysis for product code LYY, P.T. Irama Dinamika Latex's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.