The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim And Tested For Use With Chemotherapy Drugs (blue).
| Device ID | K160560 |
| 510k Number | K160560 |
| Device Name: | Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim And Tested For Use With Chemotherapy Drugs (Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA SDN BHD C-G-9 JALAN DATARAN SD1 DATARAN SD PJU 9 Bandar Seri 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-29 |
| Decision Date | 2016-08-04 |