The following data is part of a premarket notification filed by Purnabina Sdn Bhd with the FDA for Illusion Powder Free Exam Gloves, Natural Color With Vanilla Scent, Orange Color With Citric Scent And Pink Color.
| Device ID | K083571 |
| 510k Number | K083571 |
| Device Name: | ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR |
| Classification | Latex Patient Examination Glove |
| Applicant | PURNABINA SDN BHD 1A JALAN 8 PENGKALAN CHEPA 2 IND ZONE Kluang, Johor, MY 86007 |
| Contact | Robert Hill |
| Correspondent | Robert Hill PURNABINA SDN BHD 1A JALAN 8 PENGKALAN CHEPA 2 IND ZONE Kluang, Johor, MY 86007 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-03 |
| Decision Date | 2009-08-13 |