Smart Glove Corp. Sdn Bhd
Klang Selangor, MY
Smart Glove Corp. Sdn Bhd appears in FDA device records in Klang Selangor, MY. FDA records list 27 510(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
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Smart Glove Corp. Sdn Bhd between 1998 and 2009. The busiest year on record is 1998, with 6. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 6 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 5 |
| 2002 | 3 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K091147 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) | LZA | Substantially Equivalent | |
| K082370 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) | LZA | Substantially Equivalent | |
| K081466 | STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | |
| K071170 | POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL | LZA | Substantially Equivalent | |
| K063627 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) | LZA | Substantially Equivalent | |
| K061724 | POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE) | LZA | Substantially Equivalent | |
| K060726 | POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR) | LZA | Substantially Equivalent | |
| K060724 | POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY) | LZA | Substantially Equivalent | |
| K050122 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE) | LZA | Substantially Equivalent | |
| K050598 | POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) | LZA | Substantially Equivalent | |
| K033683 | SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR | LZA | Substantially Equivalent | |
| K022818 | MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR | LZA | Substantially Equivalent | |
| K021521 | STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES | LYY | Substantially Equivalent | |
| K021013 | SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE) | LZA | Substantially Equivalent | |
| K013727 | STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G | KGO | Substantially Equivalent | |
| K012856 | STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G | LYY | Substantially Equivalent | |
| K012853 | SMART GLOVE STERILE NITRILE EXAM GLOVE | LZA | Substantially Equivalent | |
| K012479 | STERILE NITRILE SURGICAL GLOVES (POWDERED) | KGO | Substantially Equivalent | |
| K011066 | STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | |
| K002568 | POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K991624 | POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K981349 | SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K981348 | SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K981347 | SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM | LYY | Substantially Equivalent | |
| K974907 | NITRILE PRE-POWDERED EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K974870 | LATEX EXAMINATION GLOVE POWDER FREE | LYY | Substantially Equivalent | |
| K974557 | SMARTTEX | 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