The following data is part of a premarket notification filed by Hartalega Ngc Sdn Bhd with the FDA for Polyisoprene Powder Free Surgical Glove Tested For Use With Chemotherapy Drugs (natural).
| Device ID | K221718 |
| 510k Number | K221718 |
| Device Name: | Polyisoprene Powder Free Surgical Glove Tested For Use With Chemotherapy Drugs (Natural) |
| Classification | Surgeon's Gloves |
| Applicant | Hartalega NGC SDN BHD NO. 1, Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang, MY 43900 |
| Contact | Kuan Mun Leong |
| Correspondent | Nurul Aisyah Kong Hartalega NGC SDN BHD NO. 1 Persiaran Tanjung Kawasan Perindustrian Tanjung Sepang, MY 43900 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-13 |
| Decision Date | 2022-09-24 |