The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Nitrile Powder Free Examination Gloves (blue).
| Device ID | K051777 |
| 510k Number | K051777 |
| Device Name: | NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Contact | Kuan Kam Hon |
| Correspondent | Kuan Kam Hon HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-01 |
| Decision Date | 2005-08-12 |