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-violet Blue (vblu).
Device ID | K151997 |
510k Number | K151997 |
Device Name: | Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs-Violet Blue (VBLU) |
Classification | Polymer Patient Examination Glove |
Applicant | HARTALEGA NGC SDN BHD NO. 1, PERSIARAN TANJUNG, LOT PT4330 KAWASAN PERINDUSTRIAN TANJUNG, JALAN B20 Sepang, MY 64000 |
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 | 2015-07-20 |
Decision Date | 2016-03-31 |