The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Sterile Nitrile Powder Free Examination Glove(vblu), Sterle Nitrile Powder Free Examination Glove(ablu).
| Device ID | K132006 |
| 510k Number | K132006 |
| Device Name: | STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA SDN BHD # 7, KAWASAN PERUSAHAAN SURIA BATANG BERJUNTAI Selangor, Darul Ehsan, MY 45600 |
| Contact | Nurul Aisyah Kong |
| Correspondent | Nurul Aisyah Kong HARTALEGA SDN BHD # 7, KAWASAN PERUSAHAAN SURIA BATANG BERJUNTAI Selangor, Darul Ehsan, 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 | 2013-07-01 |
| Decision Date | 2013-11-07 |