The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Powder Free Sterile Latex Surgical Gloves.
| Device ID | K052177 |
| 510k Number | K052177 |
| Device Name: | POWDER FREE STERILE LATEX SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Contact | Nurul Aisyah Kong |
| Correspondent | Nurul Aisyah Kong HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur, MY 52100 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-10 |
| Decision Date | 2005-12-09 |