The following data is part of a premarket notification filed by Medical Resources, Ltd. with the FDA for Phyne-touch Pf.
| Device ID | K931250 |
| 510k Number | K931250 |
| Device Name: | PHYNE-TOUCH PF |
| Classification | Latex Patient Examination Glove |
| Applicant | MEDICAL RESOURCES, LTD. 1201 OLD HOPEWELL RD. SUITE 1 Tampa, FL 33619 |
| Contact | Joseph Spicola |
| Correspondent | Joseph Spicola MEDICAL RESOURCES, LTD. 1201 OLD HOPEWELL RD. SUITE 1 Tampa, FL 33619 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-11 |
| Decision Date | 1994-01-28 |