The following data is part of a premarket notification filed by Hartalega Ngc Sdn Bhd with the FDA for Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs (white, Blue, Orange).
| Device ID | K151343 |
| 510k Number | K151343 |
| Device Name: | Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs (white, Blue, Orange) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA NGC SDN BHD NO. 1, PERSIARAN TANJUNG, LOT PT4330 KAWASAN PERINDUSTRIAN TANJUNG, JALAN B20 Sepang, MY 65000 |
| Contact | Kuan Mun Leong |
| Correspondent | Nurul Aisyah Kong HARTALEGA NGC SDN BHD C-G-9, JALAN DATARAN SD1 DATARAN SD PJU 9 Bandar Sri Damansara, MY 52200 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-19 |
| Decision Date | 2015-08-24 |