The following data is part of a premarket notification filed by Medical Resources, Ltd. with the FDA for Phyne-touch-sterile.
| Device ID | K894212 |
| 510k Number | K894212 |
| Device Name: | PHYNE-TOUCH-STERILE |
| Classification | Latex Patient Examination Glove |
| Applicant | MEDICAL RESOURCES, LTD. 520 WEST BRANNEN RD. Lakeland, FL 33813 |
| Contact | Richard Ghenn |
| Correspondent | Richard Ghenn MEDICAL RESOURCES, LTD. 520 WEST BRANNEN RD. Lakeland, FL 33813 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-19 |
| Decision Date | 1989-08-29 |