The following data is part of a premarket notification filed by Wells Lamont Corp. with the FDA for Wells Lamont Cut Resistant Surgical Glove Liners.
| Device ID | K922407 |
| 510k Number | K922407 |
| Device Name: | WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS |
| Classification | Accessory, Surgical Apparel |
| Applicant | WELLS LAMONT CORP. 6640 WEST TOUHY AVE. Niles, IL 60714 |
| Contact | Ben J Birsa |
| Correspondent | Ben J Birsa WELLS LAMONT CORP. 6640 WEST TOUHY AVE. Niles, IL 60714 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-21 |
| Decision Date | 1993-06-15 |