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 (blue).
| Device ID | K162491 |
| 510k Number | K162491 |
| Device Name: | Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA SDN. BHD. DATARAN SD PJU 9 Bandar Seri Damansara, MY 52200 |
| Contact | Kuan Kam Hon |
| Correspondent | Nurul Aisyah Kong Bt Abdullah HARTALEGA SDN. BHD. NO. 7 KAWASAN PERUSAHAAN SURIA Bestari Jaya, SE 45600 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-07 |
| Decision Date | 2017-02-08 |