The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Gloves (white/dawn Blue/dark Violet Blue (dvbu)/cobalt Blue (cblu).
| Device ID | K140890 |
| 510k Number | K140890 |
| Device Name: | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA NGC SDN. BHD. DATARAN SD PJU 9 Bandar Sri Damansara, Kuala Lumpur, MY 52200 |
| Contact | Nurul Aisyah Kong |
| Correspondent | Nurul Aisyah Kong HARTALEGA NGC SDN. BHD. DATARAN SD PJU 9 Bandar Sri Damansara, Kuala Lumpur, 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 | 2014-04-08 |
| Decision Date | 2014-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30851253007855 | K140890 | 000 |
| 30851253007848 | K140890 | 000 |
| 30851253007831 | K140890 | 000 |
| 30851253007824 | K140890 | 000 |