The following data is part of a premarket notification filed by Biosafety Systems, Inc. with the FDA for P2 Exam Gloves.
| Device ID | K944142 |
| 510k Number | K944142 |
| Device Name: | P2 EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | BIOSAFETY SYSTEMS, INC. 10225 WILLOW CREEK RD. San Diego, CA 92131 |
| Contact | Bill Howes |
| Correspondent | Bill Howes BIOSAFETY SYSTEMS, INC. 10225 WILLOW CREEK RD. San Diego, CA 92131 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-25 |
| Decision Date | 1994-10-28 |