The following data is part of a premarket notification filed by Innovative Medical Suppliers with the FDA for Patient Exam Gloves (mfg. Koon Seng).
| Device ID | K893071 |
| 510k Number | K893071 |
| Device Name: | PATIENT EXAM GLOVES (MFG. KOON SENG) |
| Classification | Latex Patient Examination Glove |
| Applicant | INNOVATIVE MEDICAL SUPPLIERS 221 WEST E STREET, SUITE 201 Encinitas, CA 92024 -3520 |
| Contact | Joseph G Osborne |
| Correspondent | Joseph G Osborne INNOVATIVE MEDICAL SUPPLIERS 221 WEST E STREET, SUITE 201 Encinitas, CA 92024 -3520 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1990-05-21 |