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 |