Pt. Mandiri Inti Buana
Medan, ID
Pt. Mandiri Inti Buana appears in FDA device records in Medan, ID. FDA records list 4 510(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
- 4
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 4 510(k) clearances for Pt. Mandiri Inti Buana between 2003 and 2005. The busiest year on record is 2003, with 2. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K051987 | FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE | LYY | Substantially Equivalent | |
| K042239 | FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE | LZA | Substantially Equivalent | |
| K031754 | FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE | LYY | Substantially Equivalent | |
| K031020 | FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, 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