The following data is part of a premarket notification filed by Conphar, Inc. with the FDA for Conphar Exam. Gloves, Polyethylene.
| Device ID | K791805 |
| 510k Number | K791805 |
| Device Name: | CONPHAR EXAM. GLOVES, POLYETHYLENE |
| Classification | Patient Examination Glove |
| Applicant | CONPHAR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-13 |
| Decision Date | 1979-10-01 |