The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Nitrile Powder Free Examination Glove (ablu).
Device ID | K130473 |
510k Number | K130473 |
Device Name: | NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) |
Classification | Polymer Patient Examination Glove |
Applicant | HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya, MY 45600 |
Contact | Nurul Aisyah Kong Bt Abdullah |
Correspondent | Nurul Aisyah Kong Bt Abdullah 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 | 2013-02-22 |
Decision Date | 2013-07-05 |