The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Polychloroprene Powder Free Surgical Glove (green).
| Device ID | K170152 |
| 510k Number | K170152 |
| Device Name: | POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) |
| 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 | 2017-01-17 |
| Decision Date | 2017-05-05 |