The following data is part of a premarket notification filed by Phoenix Glove Co. with the FDA for Patient Prep Kits/trays-sterile.
| Device ID | K821044 |
| 510k Number | K821044 |
| Device Name: | PATIENT PREP KITS/TRAYS-STERILE |
| Classification | Wrap, Sterilization |
| Applicant | PHOENIX GLOVE CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-14 |
| Decision Date | 1982-06-23 |