The following data is part of a premarket notification filed by Ug Healthcare (usa), Inc. with the FDA for Non-sterile, Powder-free Blue, Nitrile Examination Gloves.
| Device ID | K112012 |
| 510k Number | K112012 |
| Device Name: | NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | UG HEALTHCARE (USA), INC. 1565 SUNFLOWER AVE. Costa Mesa, CA 92626 |
| Contact | Ken Stanton |
| 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 | 2011-07-13 |
| Decision Date | 2012-03-21 |
| Summary: | summary |