The following data is part of a premarket notification filed by Phoenix Glove Co. with the FDA for Gloves, Vinyl Examination.
| Device ID | K781820 |
| 510k Number | K781820 |
| Device Name: | GLOVES, VINYL EXAMINATION |
| Classification | Patient Examination Glove |
| Applicant | PHOENIX GLOVE CO. 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 | 1978-10-27 |
| Decision Date | 1978-12-07 |