The following data is part of a premarket notification filed by Gem Nonwovews, Inc. with the FDA for Disposable Shoe Cover.
| Device ID | K913628 |
| 510k Number | K913628 |
| Device Name: | DISPOSABLE SHOE COVER |
| Classification | Cover, Shoe, Operating-room |
| Applicant | GEM NONWOVEWS, INC. 2800-E BOB WALLACE AVE. Huntsville, AL 35805 |
| Contact | James Mclaughlin |
| Correspondent | James Mclaughlin GEM NONWOVEWS, INC. 2800-E BOB WALLACE AVE. Huntsville, AL 35805 |
| Product Code | FXP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-15 |
| Decision Date | 1991-10-04 |