FDA 510(k) Applications Submitted by CHO SOW FONG
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230573 |
03/01/2023 |
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) |
Kossan International Sdn Bhd |
| K060724 |
03/17/2006 |
POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY) |
SMART GLOVE CORP. SDN BHD |
| K060726 |
03/17/2006 |
POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR) |
SMART GLOVE CORP. SDN BHD |
| K101828 |
07/01/2010 |
POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
GX CORPORATION SDN BHD |
| K232461 |
08/15/2023 |
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; |
Kossan International Sdn Bhd |
| K123749 |
12/06/2012 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE |
KOSSAN LATEX INDUSTRIES(M)SDN BHD |
| K120066 |
01/09/2012 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL |
KOSSAN LATEX INDUSTRIES(M)SDN BHD |
| K101293 |
05/10/2010 |
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) |
PT. SMART GLOVE INDONESIA |
| K102074 |
07/26/2010 |
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) |
GX CORPORATION SDN BHD |
| K063627 |
12/06/2006 |
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) |
SMART GLOVE CORP. SDN BHD |
| K101630 |
06/10/2010 |
POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE |
PT. SMART GLOVE INDONESIA |
| K111772 |
06/23/2011 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE |
KOSSAN LATEX INDUSTRIES(M)SDN BHD |
| K181857 |
07/11/2018 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Kossan International Sdn. Bhd. |
| K223375 |
11/04/2022 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. |
Kossan International Sdn Bhd3 |
| K093759 |
12/07/2009 |
MULTIPLE NAME MODEL MULTIPLE |
GX CORPORATION SDN BHD (PLANT 1) |
| K170397 |
02/09/2017 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy D |
Kossan International Sdn. Bhd. |
| K160467 |
02/19/2016 |
Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim |
Kossan International Sdn. Bhd. |
| K190606 |
03/08/2019 |
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile |
Kossan International Sdn. Bhd. |
| K151750 |
06/29/2015 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile |
KOSSAN INTERNATIONAL SDN. BHD. |
| K191800 |
07/03/2019 |
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim |
Kossan International Sdn. Bhd. |
| K151824 |
07/06/2015 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested |
KOSSAN INTERNATIONAL SDN. BHD. |
| K172420 |
08/10/2017 |
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim |
Wear Safe (Malaysia) Sdn. Bhd. |
| K143131 |
10/31/2014 |
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile |
Kossan International Sdn. Bhd. |
| K183287 |
11/26/2018 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fe |
Kossan International Sdn. Bhd. |
| K050526 |
03/02/2005 |
POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR |
SPI GLOVES SDN. BHD. |
| K050527 |
03/02/2005 |
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL |
SPI GLOVES SDN. BHD. |
| K050528 |
03/02/2005 |
POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK) |
SPI GLOVES SDN. BHD. |
| K050529 |
03/02/2005 |
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER |
SPI GLOVES SDN. BHD. |
| K050530 |
03/02/2005 |
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) |
SPI GLOVES SDN. BHD. |
| K050531 |
03/02/2005 |
POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE) |
SPI GLOVES SDN. BHD. |
| K050532 |
03/02/2005 |
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA |
SPI GLOVES SDN. BHD. |
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