The following data is part of a premarket notification filed by Medical Resources International, Inc. with the FDA for Ultar-shield.
| Device ID | K932702 |
| 510k Number | K932702 |
| Device Name: | ULTAR-SHIELD |
| Classification | Latex Patient Examination Glove |
| Applicant | MEDICAL RESOURCES INTERNATIONAL, INC. 1201 OLD HOPEWELL RD. Tampa, FL 33619 |
| Contact | Gene Cabrera |
| Correspondent | Gene Cabrera MEDICAL RESOURCES INTERNATIONAL, INC. 1201 OLD HOPEWELL RD. 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 | 1993-06-03 |
| Decision Date | 1994-03-07 |