The following data is part of a premarket notification filed by Hartalega Sdn. Bhd. with the FDA for Polyisoprene Powder Free Surgical Underglove, Polyisoprene Powder Free Surgical Glove.
| Device ID | K161008 |
| 510k Number | K161008 |
| Device Name: | POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | HARTALEGA SDN. BHD. DATARAN SD PJU 9 Bandar Sri Damansara, MY 52200 |
| Contact | Kuan Kam Hon |
| Correspondent | Nurul Aisyah Kong HARTALEGA SDN. BHD. NO. 7 KAWASAN PERUSAHAAN SURIA Bestari Jaya, MY 45600 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-11 |
| Decision Date | 2016-07-28 |