The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Nitrile Powder Free Examination Gloves (orange) Tested For Use With Chemotherapy Drugs.
| Device ID | K150103 |
| 510k Number | K150103 |
| Device Name: | Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA SDN BHD C-G-9 JALAN DATARAN SD1 DATARAN SD PJU 9 Bandar Sri Damansara, MY 52200 |
| Contact | Kuan Kam Hon |
| Correspondent | Nurul Aisyah Kong Bt Abdullah HARTALEGA SDB. BHD. NO. 7 KAWASAN PERUSAHAAN SURIA Bestari Jaya, Selangor, 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 | 2015-01-20 |
| Decision Date | 2015-04-23 |