Kossan International Sdn Bhd · Class I · Cleared Nov 14, 2023
| K-number | K232461 |
| Device name | 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; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis |
| Applicant | Kossan International Sdn Bhd |
| Product code | LZA |
| Device class | Class I |
| Decision date | Nov 14, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 880.6250 |
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