The following data is part of a premarket notification filed by Wells Lamont Corp. with the FDA for Nylon Liner Gloves.
| Device ID | K940274 |
| 510k Number | K940274 |
| Device Name: | NYLON LINER GLOVES |
| Classification | Accessory, Surgical Apparel |
| Applicant | WELLS LAMONT CORP. 6640 WEST TOUHY AVE. Niles, IL 60714 |
| Contact | Paula Gordon |
| Correspondent | Paula Gordon 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 | 1994-01-21 |
| Decision Date | 1994-05-12 |