FDA 510(k) Applications Submitted by KOSSAN INTERNATIONAL SDN. BHD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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. |
| 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. |
| 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. |
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