The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Powder Free Latex Examination Glove.
| Device ID | K960467 |
| 510k Number | K960467 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | BIOPRO, INC. 22 DOGWOOD DR. Chester, NJ 07930 |
| Contact | Muriel G Willich |
| Correspondent | Muriel G Willich BIOPRO, INC. 22 DOGWOOD DR. Chester, NJ 07930 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-30 |
| Decision Date | 1996-05-24 |