The following data is part of a premarket notification filed by Hartalega Sdn. Bhd. with the FDA for Polyisoprene Powder Free Surgical Underglove For Use With Chemotherapy Drugs (blue), Polyisoprene Powder Free Surgical Glove For Use With Chemotherapy Drugs (natural).
| Device ID | K200897 |
| 510k Number | K200897 |
| Device Name: | Polyisoprene Powder Free Surgical Underglove For Use With Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove For Use With Chemotherapy Drugs (Natural) |
| Classification | Surgeon's Gloves |
| Applicant | Hartalega SDN. BHD. Dataran SD PJU9 Bandar Sri Damansara, MY 52200 |
| Contact | Kuan Kam Hon |
| Correspondent | Nurul Aisyah Kong Hartalega SDN. NHD 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 | 2020-04-03 |
| Decision Date | 2020-06-01 |