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 Drug With Protein Labeling Claim Of 50 M.
Device ID | K133953 |
510k Number | K133953 |
Device Name: | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M |
Classification | Latex Patient Examination Glove |
Applicant | HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya, Selangor, MY 45600 |
Contact | Nurul Aisyah Kong Bt Abdullah |
Correspondent | Nurul Aisyah Kong Bt Abdullah 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 | 2013-12-23 |
Decision Date | 2014-05-28 |