The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Nitrile Powder Free Examination Glove With Colloidal Oatmeal Usp Skin Protectant Drug - Dkbu /dark Blue.
Device ID | K140050 |
510k Number | K140050 |
Device Name: | NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE |
Classification | Polymer Patient Examination Glove |
Applicant | HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya, MY 45600 |
Contact | Nurul Aishyah Kong |
Correspondent | Nurul Aishyah 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 | 2014-01-09 |
Decision Date | 2014-09-12 |