Company ยท MY
Smart Glove Corp. Sdn Bhd
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2022. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2022 | K213373 | Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Smart Glove Corporation Sdn. Bhd., MY | LZA |
| Jul 26, 2019 | K183280 | PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs Smart Glove Corporation Sdn. Bhd., MY | LZA |
| Jan 9, 2019 | K181047 | Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs Smart Glove Corporation Sdn. Bhd., MY | KGO |
| Aug 8, 2018 | K180221 | Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs Smart Glove Corporation Sdn. Bhd., MY | KGO |
| Nov 17, 2017 | K171743 | Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination G Smart Glove Corporation Sdn. Bhd., MY | LZA |
| Jul 27, 2009 | K091147 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) Smart Glove Corp. Sdn Bhd, MY | LZA |
| Oct 17, 2008 | K082370 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) Smart Glove Corp. Sdn Bhd, MY | LZA |
| Jul 30, 2008 | K081466 | STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE Smart Glove Corp. Sdn Bhd, MY | LZA |
| Sep 14, 2007 | K071170 | POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL Smart Glove Corp. Sdn Bhd, MY | LZA |
| Mar 20, 2007 | K063627 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) Smart Glove Corp. Sdn Bhd, MY | LZA |
| Jul 25, 2006 | K061724 | POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE) Smart Glove Corp. Sdn Bhd, MY | LZA |
| May 25, 2006 | K060726 | POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR) Smart Glove Corp. Sdn Bhd, MY | LZA |
| May 17, 2006 | K060724 | POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY) Smart Glove Corp. Sdn Bhd, MY | LZA |
| Apr 18, 2005 | K050122 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE) Smart Glove Corp. Sdn Bhd, MY | LZA |
| Apr 7, 2005 | K050598 | POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) Smart Glove Corp. Sdn Bhd, MY | LZA |
| Jan 8, 2004 | K033683 | SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR Smart Glove Corp. Sdn Bhd, MY | LZA |
| Sep 17, 2002 | K022818 | MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR Smart Glove Corp. Sdn Bhd, MY | LZA |
| Jul 2, 2002 | K021521 | STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES Smart Glove Corp. Sdn Bhd, MY | LYY |
| May 22, 2002 | K021013 | SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE) Smart Glove Corp. Sdn Bhd, MY | LZA |
| Dec 7, 2001 | K013727 | STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G Smart Glove Corp. Sdn Bhd, MY | KGO |
| Nov 16, 2001 | K012856 | STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G Smart Glove Corp. Sdn Bhd, MY | LYY |
| Nov 16, 2001 | K012853 | SMART GLOVE STERILE NITRILE EXAM GLOVE Smart Glove Corp. Sdn Bhd, MY | LZA |
| Sep 26, 2001 | K012479 | STERILE NITRILE SURGICAL GLOVES (POWDERED) Smart Glove Corp. Sdn Bhd, MY | KGO |
| Sep 11, 2001 | K011066 | STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) Smart Glove Corp. Sdn Bhd, MY | KGO |
| Oct 3, 2000 | K002568 | POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Smart Glove Corp. Sdn Bhd, MY | LYY |
| Jul 9, 1999 | K991624 | POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES Smart Glove Corp. Sdn Bhd, MY | LYY |
| May 18, 1998 | K981349 | SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES Smart Glove Corp. Sdn Bhd, MY | LZA |
| May 18, 1998 | K981348 | SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES Smart Glove Corp. Sdn Bhd, MY | LYY |
| May 18, 1998 | K981347 | SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM Smart Glove Corp. Sdn Bhd, MY | LYY |
| Mar 13, 1998 | K974907 | NITRILE PRE-POWDERED EXAMINATION GLOVES Smart Glove Corp. Sdn Bhd, MY | LZA |
| Mar 13, 1998 | K974870 | LATEX EXAMINATION GLOVE POWDER FREE Smart Glove Corp. Sdn Bhd, MY | LYY |
| Mar 13, 1998 | K974557 | SMARTTEX Smart Glove Corp. Sdn Bhd, MY | LYY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||