The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Regent Dispo Sterile Biogel Starch Free Surg Glove.
| Device ID | K874099 |
| 510k Number | K874099 |
| Device Name: | REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | BIOPRO, INC. 28 BEACH FRONT LN. New Rochelle, NY 10805 |
| Contact | Gordon D Coplein |
| Correspondent | Gordon D Coplein BIOPRO, INC. 28 BEACH FRONT LN. New Rochelle, NY 10805 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-08 |
| Decision Date | 1987-12-14 |