| K-number | K913628 |
| Device name | DISPOSABLE SHOE COVER |
| Applicant | Gem Nonwovews, Inc. |
| Product code | FXP |
| Device class | Class I |
| Decision date | Oct 4, 1991 |
| 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