The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Nitrile Powder Free Examination Gloves (vio) Tested For Use With Chenitrile Powder Free Examination (ablu) Tested For U.
| Device ID | K120336 |
| 510k Number | K120336 |
| Device Name: | NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U |
| Classification | Patient Examination Glove, Specialty |
| Applicant | HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya, MY 45600 |
| Contact | Nurul Aisyah Kong |
| Correspondent | Nurul Aisyah Kong HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya, MY 45600 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-03 |
| Decision Date | 2012-06-25 |