The following data is part of a premarket notification filed by Hartalega Sdn. Bhd. with the FDA for 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.
| Device ID | K180786 |
| 510k 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 |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA SDN. BHD. Dataran Sd Pju 9 Bandar Sri Damansara, MY 52200 |
| Contact | Kuan Kam Hon |
| Correspondent | Nurual Aisyah Kong HARTALEGA SDN. BHD. No. 7, Kawasan Perusahaan Suria Bestari Jaya, MY 45600 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-26 |
| Decision Date | 2018-11-02 |