The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Patient Examination Gloves.
| Device ID | K143419 |
| 510k Number | K143419 |
| Device Name: | Patient Examination Gloves |
| Classification | Latex Patient Examination Glove |
| Applicant | HARTALEGA NGC SDN. BHD. KAWASAN PERINDUSTRIAN TANJUNG, JALAN B20 Sepang, MY 64000 |
| Contact | Kuan Mun Leong |
| Correspondent | Nurul Aisyah Kong HARTALEGA NGC SDN. BHD. DATARAN SD PJU 9 Bandar Sri Damansara, MY 52200 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-28 |
| Decision Date | 2015-03-06 |