The following data is part of a premarket notification filed by Concordia Research Lab with the FDA for Dermatouch Latex Gloves.
| Device ID | K955670 |
| 510k Number | K955670 |
| Device Name: | DERMATOUCH LATEX GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | CONCORDIA RESEARCH LAB 1812 NORTH VERMONT AVE. Los Angeles, CA 90027 |
| Contact | Charles H Rabbie |
| Correspondent | Charles H Rabbie CONCORDIA RESEARCH LAB 1812 NORTH VERMONT AVE. Los Angeles, CA 90027 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-08 |
| Decision Date | 1996-03-06 |