The following data is part of a premarket notification filed by Medical Resources, Ltd. with the FDA for Pyne/chemo-touch, Ultra-shield, Pyne-sterie, Modif.
| Device ID | K914628 |
| 510k Number | K914628 |
| Device Name: | PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF |
| Classification | Latex Patient Examination Glove |
| Applicant | MEDICAL RESOURCES, LTD. 520 WEST BRANNEN RD. Lakeland, FL 33813 |
| Contact | Richard H Ghenn |
| Correspondent | Richard H 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 | 1991-08-13 |
| Decision Date | 1991-11-07 |