The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Latex Powder Free Examination Gloves With Colloidal Oatmeal Usp Skin Protectant.
| Device ID | K123368 |
| 510k Number | K123368 |
| Device Name: | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT |
| Classification | Latex Patient Examination Glove |
| Applicant | HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya Selangor, MY 45600 |
| Contact | Nurul Aisyah Kong |
| Correspondent | Nurul Aisyah Kong HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya Selangor, MY 45600 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-01 |
| Decision Date | 2013-05-07 |