Pt. Smartglove Indonesia
Tg Morawa-Deli Serdang Utara, ID
Pt. Smartglove Indonesia appears in FDA device records in Tg Morawa-Deli Serdang Utara, ID. FDA records list 12 510(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
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Pt. Smartglove Indonesia between 2003 and 2014. The busiest year on record is 2003, with 5. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 5 |
| 2004 | 3 |
| 2009 | 1 |
| 2010 | 2 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133699 | POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K101630 | POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE | LZA | Substantially Equivalent | |
| K101293 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) | LZA | Substantially Equivalent | |
| K092034 | POWDER FREE NITRILE EXAMINATION GLOVES, BLACK | LZA | Substantially Equivalent | |
| K041848 | POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR | LZA | Substantially Equivalent | |
| K040792 | POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) | LYY | Substantially Equivalent | |
| K040791 | POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) | LZA | Substantially Equivalent | |
| K030284 | POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE) | LZA | Substantially Equivalent | |
| K030406 | NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR | LZA | Substantially Equivalent | |
| K030112 | POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB | LYY | Substantially Equivalent | |
| K022814 | MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED) | LZA | Substantially Equivalent | |
| K022815 | MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX | 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