Hartalega Sdn Bhd · Class I · Cleared Nov 2, 2018
| K-number | K180786 |
| Device name | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff |
| Applicant | Hartalega Sdn Bhd |
| Product code | LZA |
| Device class | Class I |
| Decision date | Nov 2, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 880.6250 |
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