The following data is part of a premarket notification filed by Hartalega Sdn. Bhd. with the FDA for Biodegradable Nitrile Powder Free Examination Glove (blue).
| Device ID | K173509 |
| 510k Number | K173509 |
| Device Name: | Biodegradable Nitrile Powder Free Examination Glove (Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Hartalega Sdn. Bhd. Dataran SD PJU 9 Bandar Sri 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 | 2017-11-13 |
| Decision Date | 2018-08-17 |