The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs (white).
Device ID | K170794 |
510k Number | K170794 |
Device Name: | Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs (White) |
Classification | Polymer Patient Examination Glove |
Applicant | HARTALEGA NGC SDN. BHD. No.1 Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang, MY 43900 |
Contact | Kuan Mun Leong |
Correspondent | Nurul Aisyah Kong Bt Abdullah 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 | 2017-03-16 |
Decision Date | 2017-06-30 |