Pt Mahakarya Inti Buana
Morawa, Sumut, ID
Pt Mahakarya Inti Buana appears in FDA device records in Morawa, Sumut, ID. FDA records list 9 510(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
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Pt Mahakarya Inti Buana between 2005 and 2011. The busiest year on record is 2006, with 5. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 5 |
| 2007 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K111300 | SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE) | LZA | Substantially Equivalent | |
| K090464 | BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE | LZA | Substantially Equivalent | |
| K063581 | SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE | LYY | Substantially Equivalent | |
| K062313 | SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE | LYY | Substantially Equivalent | |
| K061233 | SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE | LYY | Substantially Equivalent | |
| K053305 | SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE | LYY | Substantially Equivalent | |
| K053366 | NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE | LZA | Substantially Equivalent | |
| K053657 | POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE | LZA | Substantially Equivalent | |
| K052273 | POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE | 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