The following data is part of a premarket notification filed by Ug Global Resources Sdn Bhd with the FDA for Unitex Non-sterile, Powder-free, Latex Examination Glove.
| Device ID | K161961 |
| 510k Number | K161961 |
| Device Name: | UniTex Non-Sterile, Powder-Free, Latex Examination Glove |
| Classification | Latex Patient Examination Glove |
| Applicant | UG GLOBAL RESOURCES SDN BHD Lot 62 & 63, Lorong Senawang 3/2 Kawasan Perindustrian Senawang Seremban, MY 70450 |
| Contact | Wong See Keong |
| Correspondent | Kenneth J. Stanton UG Healthcare (USA) Inc. 1565 Sunflower Avenue Costa Mesa, CA 92626 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-18 |
| Decision Date | 2017-05-11 |
| Summary: | summary |