Pt Mahakarya Inti Buana: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Pt Mahakarya Inti Buana” (first 2005, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 105 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 | 5 | 5 |
| LZA | Polymer Patient Examination Glove | 4 | 4 |
Review panels
- General Hospital (9)
Most recent Pt Mahakarya Inti Buana 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111300 | SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE) | LZA | 2011-08-12 | 95 |
| K090464 | BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE | LZA | 2009-04-23 | 59 |
| K063581 | SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE | LYY | 2007-03-15 | 105 |
| K062313 | SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE | LYY | 2006-11-30 | 114 |
| K061233 | SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE | LYY | 2006-11-03 | 185 |
| K053305 | SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE | LYY | 2006-06-02 | 186 |
| K053366 | NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE | LZA | 2006-03-30 | 115 |
| K053657 | POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE | LZA | 2006-02-13 | 70 |
| K052273 | POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE | LYY | 2005-09-30 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Pt Mahakarya Inti Buana.
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 Pt Mahakarya Inti Buana?
FDA lists 9 510(k) clearances under the applicant name “Pt Mahakarya Inti Buana” (first 2005, latest 2011), 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 Pt Mahakarya Inti Buana?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pt Mahakarya Inti Buana is 105 days.
Which FDA product codes appear under Pt Mahakarya Inti Buana?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 5); LZA (Polymer Patient Examination Glove, 4).
Next steps
- See all 9 Pt Mahakarya Inti Buana clearances with predicates and recalls
- Run predicate analysis for product code LYY, Pt Mahakarya Inti Buana'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.