The following data is part of a premarket notification filed by Ug Global Resources Sdn. Bhd. with the FDA for Non-sterile, Powder-free, Nitrile Examination Gloves, Blue.
| Device ID | K162510 |
| 510k Number | K162510 |
| Device Name: | Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue |
| Classification | Polymer Patient Examination Glove |
| Applicant | UG GLOBAL RESOURCES SDN. BHD. 1ST FLOOR NO.18, JALAN DATO ABD RAHMAN Seremban, MY 70000 |
| Contact | Wong See Keong |
| Correspondent | Ken Stanton UG HEALTHCARE (USA) INC. 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 | 2016-09-08 |
| Decision Date | 2017-07-18 |
| Summary: | summary |