The following data is part of a premarket notification filed by Asia Dynamics, Inc. with the FDA for Mic Non-sterile Latex Gloves.
| Device ID | K891160 |
| 510k Number | K891160 |
| Device Name: | MIC NON-STERILE LATEX GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ASIA DYNAMICS, INC. 5875 N. LINCOLN AVE., SUITE 243 Chicago, IL 60659 |
| Contact | Jeongling Liu |
| Correspondent | Jeongling Liu ASIA DYNAMICS, INC. 5875 N. LINCOLN AVE., SUITE 243 Chicago, IL 60659 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-06 |
| Decision Date | 1989-10-13 |