The following data is part of a premarket notification filed by Simpex, Inc. with the FDA for Easy Touch Latex Eam Gloves.
| Device ID | K920174 |
| 510k Number | K920174 |
| Device Name: | EASY TOUCH LATEX EAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | SIMPEX, INC. 801 OLD YORK RD. SUITE 318 Jenkintown, PA 19046 |
| Contact | Xi Mei |
| Correspondent | Xi Mei SIMPEX, INC. 801 OLD YORK RD. SUITE 318 Jenkintown, PA 19046 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-14 |
| Decision Date | 1992-04-22 |