The following data is part of a premarket notification filed by Nitrilist Gloves Manufacturing Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves, Blue And Black.
| Device ID | K123328 |
| 510k Number | K123328 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK |
| Classification | Polymer Patient Examination Glove |
| Applicant | NITRILIST GLOVES MANUFACTURING SDN BHD PT 197, KAWASAN PERINDUSTRIAN DIOH Kuala Pilah, MY 72000 |
| Contact | Lau Siong Hut |
| Correspondent | Lau Siong Hut NITRILIST GLOVES MANUFACTURING SDN BHD PT 197, KAWASAN PERINDUSTRIAN DIOH Kuala Pilah, MY 72000 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-22 |
| Decision Date | 2013-01-18 |