The following data is part of a premarket notification filed by Pfb Inter-apparel Corp. with the FDA for Isolation Gowns.
| Device ID | K922442 |
| 510k Number | K922442 |
| Device Name: | ISOLATION GOWNS |
| Classification | Gown, Isolation, Surgical |
| Applicant | PFB INTER-APPAREL CORP. 8751 N.W. 102ND ST. Medley, FL 33178 |
| Contact | Wilhelm E Lemke |
| Correspondent | Wilhelm E Lemke PFB INTER-APPAREL CORP. 8751 N.W. 102ND ST. Medley, FL 33178 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-22 |
| Decision Date | 1993-10-12 |