The following data is part of a premarket notification filed by Medical Resources, Ltd. with the FDA for Chemo-touch.
| Device ID | K895195 |
| 510k Number | K895195 |
| Device Name: | CHEMO-TOUCH |
| Classification | Patient Examination Glove, Specialty |
| Applicant | MEDICAL RESOURCES, LTD. 520 WEST BRANNEN RD. Lakeland, FL 33813 |
| Contact | Donna L Powell |
| Correspondent | Donna L Powell MEDICAL RESOURCES, LTD. 520 WEST BRANNEN RD. Lakeland, FL 33813 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-11 |
| Decision Date | 1990-03-15 |