The following data is part of a premarket notification filed by Dispomed, Inc. with the FDA for Patient Exam Gloves (mfg. Ammatex).
| Device ID | K892748 |
| 510k Number | K892748 |
| Device Name: | PATIENT EXAM GLOVES (MFG. AMMATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | DISPOMED, INC. 1201 SOUTH FLOWER ST. Burbank, CA 91520 |
| Contact | Kent Braniff |
| Correspondent | Kent Braniff DISPOMED, INC. 1201 SOUTH FLOWER ST. Burbank, CA 91520 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-08-10 |