The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Nitrile Gloves.
| Device ID | K970135 |
| 510k Number | K970135 |
| Device Name: | NITRILE GLOVES |
| Classification | Patient Examination Glove, Specialty |
| Applicant | SAGE PRODUCTS, INC. 815 TEK DR. Crystal Lake, IL 60014 -8172 |
| Contact | Karen Pinto |
| Correspondent | Karen Pinto SAGE PRODUCTS, INC. 815 TEK DR. Crystal Lake, IL 60014 -8172 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-15 |
| Decision Date | 1997-08-25 |
| Summary: | summary |