| K-number | K921058 |
| Device name | DISPOSABLE ISOLATION GOWN |
| Applicant | Nat'L Surtex Corp. |
| Product code | FYC |
| Device class | Class II |
| Decision date | Aug 11, 1992 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov