The following data is part of a premarket notification filed by Hartalega Sdb. Bhd. with the FDA for Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs (white); Dark Violet Blue (dvbu); Dark Blue (dkbu).
| Device ID | K162924 |
| 510k Number | K162924 |
| Device Name: | Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA SDB. BHD. DATARAN SD PJU9 Bandar Sri Damansara, MY 52200 |
| Contact | Kuan Kam Hon |
| Correspondent | Nurual Aisyah Kong HARTALEGA SDB. 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 | 2016-10-18 |
| Decision Date | 2017-01-24 |