The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Cut Resistant Glove Liner.
| Device ID | K902633 |
| 510k Number | K902633 |
| Device Name: | CUT RESISTANT GLOVE LINER |
| Classification | Accessory, Surgical Apparel |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Lonnie Witham |
| Correspondent | Lonnie Witham BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-14 |
| Decision Date | 1990-07-27 |