The following data is part of a premarket notification filed by Biosafety Systems, Inc. with the FDA for P2/chemo Plus Gloves.
| Device ID | K900368 |
| 510k Number | K900368 |
| Device Name: | P2/CHEMO PLUS GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | BIOSAFETY SYSTEMS, INC. 8380 CAMINO SANTA FE San Diego, CA 92121 |
| Contact | Hank Kraus |
| Correspondent | Hank Kraus BIOSAFETY SYSTEMS, INC. 8380 CAMINO SANTA FE San Diego, CA 92121 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-26 |
| Decision Date | 1990-03-08 |