The following data is part of a premarket notification filed by Phoenix Glove Co. with the FDA for Sterile Surgical Drapes.
| Device ID | K821666 |
| 510k Number | K821666 |
| Device Name: | STERILE SURGICAL DRAPES |
| Classification | Declotting Tray, Kit (including Contents) |
| Applicant | PHOENIX GLOVE CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FJZ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-07 |
| Decision Date | 1982-06-21 |