The following data is part of a premarket notification filed by Ug Global Resources Sdn Bhd with the FDA for Lano-e.
| Device ID | K111718 |
| 510k Number | K111718 |
| Device Name: | LANO-E |
| Classification | Polymer Patient Examination Glove |
| Applicant | UG GLOBAL RESOURCES SDN BHD 1565 SUNFLOWER AVE. Costa Mesa, CA 92626 |
| Contact | Kenneth Stanton |
| Correspondent | Kenneth Stanton UG GLOBAL RESOURCES SDN BHD 1565 SUNFLOWER AVE. Costa Mesa, CA 92626 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-20 |
| Decision Date | 2012-06-08 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LANO-E 77276892 3430616 Live/Registered |
UG Healthcare (USA), Inc. 2007-09-11 |