The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (fusion Dark Grey).
| Device ID | K201530 |
| 510k Number | K201530 |
| Device Name: | Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs And Fentanyl, Citrate (Fusion Dark Grey) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Hartalega Ngc Sdn. Bhd. Kawasan Perindustrian Tanjung Sepang, MY 43900 |
| Contact | Kuan Mun Leong |
| Correspondent | Nurul Aisyah Kong Hartalega Ngc Sdn. Bhd. Kawasan Perindustrian Tanjung Sepang, MY 43900 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-08 |
| Decision Date | 2020-08-05 |