Pt. Maja Agung Latexindo: FDA clearances and approvals
Pt. Maja Agung Latexindo has 11 FDA 510(k) clearances (first 1990, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time: 86 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 310 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 288 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Pt. Maja Agung Latexindo's cleared 510(k)s took a median 299 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 7 | 7 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| LZA | Polymer Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (11)
Most recent Pt. Maja Agung Latexindo 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212408 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) | LZA | 2022-05-18 | 288 |
| K161099 | Powder Free Nitrile Examination Gloves, Black | LZA | 2017-02-23 | 310 |
| K081488 | POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | LYY | 2008-08-28 | 92 |
| K062709 | POWDER FREE LATEX EXAMINATION GLOVES, BLACK | LYY | 2006-12-06 | 86 |
| K020040 | LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM | LYY | 2002-08-01 | 206 |
| K013996 | LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE | LYY | 2002-02-26 | 85 |
| K001274 | LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | 2000-06-23 | 64 |
| K994255 | LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE | LYY | 2000-02-07 | 52 |
| K992752 | SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5 | KGO | 1999-11-05 | 81 |
| K982897 | POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 1998-12-23 | 128 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pt. Maja Agung Latexindo.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Pt. Maja Agung Latexindo have?
Pt. Maja Agung Latexindo has 11 FDA 510(k) clearances (first 1990, latest 2022), across 3 product codes in 1 review panel.
How long does FDA take to clear Pt. Maja Agung Latexindo's 510(k)s?
The median time from FDA receipt to decision across Pt. Maja Agung Latexindo's cleared 510(k)s is 86 days.
What devices does Pt. Maja Agung Latexindo make?
Its most frequent FDA product codes are LYY (Latex Patient Examination Glove, 7); KGO (Surgeon'S Gloves, 2); LZA (Polymer Patient Examination Glove, 2).
Has Pt. Maja Agung Latexindo had device recalls?
openFDA lists no recalls under a recalling firm name matching Pt. Maja Agung Latexindo. Related entities may recall under other names.
Next steps
- See all 11 Pt. Maja Agung Latexindo clearances with predicates and recalls
- Run predicate analysis for product code LYY, Pt. Maja Agung Latexindo's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.