The following data is part of a premarket notification filed by Allo Pro Corp. with the FDA for Surgical Cotton Gloves.
| Device ID | K900425 |
| 510k Number | K900425 |
| Device Name: | SURGICAL COTTON GLOVES |
| Classification | Accessory, Surgical Apparel |
| Applicant | ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
| Contact | Sylvia K Pierpoint |
| Correspondent | Sylvia K Pierpoint ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-30 |
| Decision Date | 1990-09-07 |