The following data is part of a premarket notification filed by Hartalega Sdb. Bhd. with the FDA for Nitrile Powder Free Examination Glove With Colloidal Oatmeal Usp Skin Protectant Drug- Dark Violet Blue (dvbu).
Device ID | K142805 |
510k Number | K142805 |
Device Name: | Nitrile Powder Free Examination Glove With Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) |
Classification | Polymer Patient Examination Glove |
Applicant | HARTALEGA SDB. BHD. DATARAN SD PJU9 Bandar Sri Damansara, MY 52200 |
Contact | Kuan Kam Hon |
Correspondent | Nurul Aisyah Kong Bt Abdullah HARTALEGA SDB. 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 | 2014-09-29 |
Decision Date | 2014-12-18 |