The following data is part of a premarket notification filed by Pinnacle Distributors, Inc. with the FDA for Glove, Superflex Molded.
| Device ID | K781852 |
| 510k Number | K781852 |
| Device Name: | GLOVE, SUPERFLEX MOLDED |
| Classification | Shield, Protective, Personnel |
| Applicant | PINNACLE DISTRIBUTORS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPY |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-06 |
| Decision Date | 1978-11-15 |