The following data is part of a premarket notification filed by Unicorn Latex, Ltd. with the FDA for Patient Examination Gloves.
| Device ID | K902617 |
| 510k Number | K902617 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | UNICORN LATEX, LTD. RAYMAR 16360 BROADWAY AVENUE Cleveland, OH 44137 |
| Contact | Shiv K Aggarwal |
| Correspondent | Shiv K Aggarwal UNICORN LATEX, LTD. RAYMAR 16360 BROADWAY AVENUE Cleveland, OH 44137 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-13 |
| Decision Date | 1990-08-10 |