The following data is part of a premarket notification filed by Platinum Glove Industries Sdn.bhd. with the FDA for Powder Free Nitrile Examination Gloves (white, Blue, And Purple Color).
| Device ID | K051318 |
| 510k Number | K051318 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR) |
| Classification | Polymer Patient Examination Glove |
| Applicant | PLATINUM GLOVE INDUSTRIES SDN.BHD. 4015A, FL 4,PRESIDENT HSE, JLN SULTAN ISMAIL Kuala Lumpur, MY 50250 |
| Contact | So Soon Cheaw |
| Correspondent | So Soon Cheaw PLATINUM GLOVE INDUSTRIES SDN.BHD. 4015A, FL 4,PRESIDENT HSE, JLN SULTAN ISMAIL Kuala Lumpur, MY 50250 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-20 |
| Decision Date | 2005-06-17 |