The following data is part of a premarket notification filed by Ug Healthcare (usa), Inc. with the FDA for Non-sterile, Powder-free, Green Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K112005 |
| 510k Number | K112005 |
| Device Name: | NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | UG HEALTHCARE (USA), INC. 1656 SUNFLOWER AVE. Costa Mesa, CA 92626 |
| Contact | Ken Stanton |
| Correspondent | Ken Stanton UG HEALTHCARE (USA), INC. 1656 SUNFLOWER AVE. 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 | 2011-07-13 |
| Decision Date | 2012-03-21 |
| Summary: | summary |