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 - Aqua Blue; Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs - Violet Blue; Nitrile Powder Free Examination Glove Tested For Use With Chemothera.
| Device ID | K162923 |
| 510k Number | K162923 |
| Device Name: | NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERA |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA NGC SDN. BHD. 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 9C 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 | 2016-10-18 |
| Decision Date | 2017-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850045738051 | K162923 | 000 |
| 00850045738044 | K162923 | 000 |
| 00850045738037 | K162923 | 000 |
| 00850045738020 | K162923 | 000 |
| 00850045738013 | K162923 | 000 |