The following data is part of a premarket notification filed by N.s. Uni-gloves Sdn. Bhd. with the FDA for Lano-e Powder-free Nitrile Examination Glove.
| Device ID | K050765 |
| 510k Number | K050765 |
| Device Name: | LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | N.S. UNI-GLOVES SDN. BHD. 2420 CARSON ST. SUITE 125 Torrance, LA |
| Contact | Kenneth J Stanton |
| Correspondent | Kenneth J Stanton N.S. UNI-GLOVES SDN. BHD. 2420 CARSON ST. SUITE 125 Torrance, LA |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-24 |
| Decision Date | 2005-04-08 |
| Summary: | summary |