Kossan International Sdn Bhd · Class I · Cleared Apr 5, 2019
| K-number | K183287 |
| Device name | 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 Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
| Applicant | Kossan International Sdn Bhd |
| Product code | LZA |
| Device class | Class I |
| Decision date | Apr 5, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 880.6250 |
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