The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove.
| Device ID | K183389 |
| 510k Number | K183389 |
| Device Name: | Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove |
| Classification | Surgeon's Gloves |
| Applicant | Hartalega NGC Sdn. Bhd. Kawasan Perindustrian Tanjung Sepang, MY 43900 |
| Contact | Kuan Leong |
| Correspondent | Nurul Aisyah Kong Hartalega NGC Sdn. Bhd. Dataran Sd Pju 9 Bandar Sri Damansara, MY 52200 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-06 |
| Decision Date | 2019-06-28 |