The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (blue).
| Device ID | K162646 |
| 510k Number | K162646 |
| Device Name: | Nitrile Powder Free Examination Glove With Low Dermatitis Potential Claim (Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA NGC SDN. BHD. KAWASAN PERINDUSTRIAN TANJUNG, Sepang, MY 43900 |
| Contact | Kuan Mun Leong |
| Correspondent | Nurul Aisyah Kong Bt Abdullah HARTALEGA NGC SDN. BHD. DATARAN SD PJU 9 Bandar Sri Damansara,, MY 52200 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-22 |
| Decision Date | 2017-03-03 |