The following data is part of a premarket notification filed by Promedica Products, Inc. with the FDA for Patient Examination Gloves (poly).
| Device ID | K892768 |
| 510k Number | K892768 |
| Device Name: | PATIENT EXAMINATION GLOVES (POLY) |
| Classification | Polymer Patient Examination Glove |
| Applicant | PROMEDICA PRODUCTS, INC. 620 NEWPORT CENTER DR., SUITE 575 Newport Beach, CA 92660 |
| Contact | Lee Hand |
| Correspondent | Lee Hand PROMEDICA PRODUCTS, INC. 620 NEWPORT CENTER DR., SUITE 575 Newport Beach, CA 92660 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-06-14 |