The following data is part of a premarket notification filed by Hartalega Snd. Bhd. with the FDA for Nitrile Powder Free Examination Gloves (white) With Colloidal Oatm.
| Device ID | K112976 |
| 510k Number | K112976 |
| Device Name: | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA SND. BHD. NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya, MY 45600 |
| Contact | Nurul A Kong |
| Correspondent | Nurul A Kong HARTALEGA SND. 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 | 2011-10-06 |
| Decision Date | 2012-02-02 |