The following data is part of a premarket notification filed by Biosafety Systems, Inc. with the FDA for P2 Nitrile Exam Gloves.
| Device ID | K944514 |
| 510k Number | K944514 |
| Device Name: | P2 NITRILE EXAM GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | BIOSAFETY SYSTEMS, INC. 10255 WILLOW CREEK RD. San Diego, CA 92131 |
| Contact | Bill Howes |
| Correspondent | Bill Howes BIOSAFETY SYSTEMS, INC. 10255 WILLOW CREEK RD. San Diego, CA 92131 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-15 |
| Decision Date | 1994-11-28 |