The following data is part of a premarket notification filed by Dynatech Medical Products with the FDA for Dr. Boo Latex Examination Gloves.
| Device ID | K893520 |
| 510k Number | K893520 |
| Device Name: | DR. BOO LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | DYNATECH MEDICAL PRODUCTS 605 WHITE HILLS DR. Rockwall, TX 75087 |
| Contact | Mitchell Davis |
| Correspondent | Mitchell Davis DYNATECH MEDICAL PRODUCTS 605 WHITE HILLS DR. Rockwall, TX 75087 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-08 |
| Decision Date | 1989-08-21 |