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 Black; Blue, Grape Scented.
| Device ID | K091965 |
| 510k Number | K091965 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED |
| Classification | Polymer Patient Examination Glove |
| Applicant | PLATINUM GLOVE INDUSTRIES SDN.BHD. 18-2-2 JALAN SETIA PRIMA (Q) U13/Q, SETIA ALAM U13 Shah Alam, Selangor, MY 40170 |
| Contact | So Soon Cheaw |
| Correspondent | So Soon Cheaw PLATINUM GLOVE INDUSTRIES SDN.BHD. 18-2-2 JALAN SETIA PRIMA (Q) U13/Q, SETIA ALAM U13 Shah Alam, Selangor, MY 40170 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-01 |
| Decision Date | 2009-11-24 |