The following data is part of a premarket notification filed by Ambusco Co., Inc. with the FDA for Patient Examination Glove (latex).
| Device ID | K891114 |
| 510k Number | K891114 |
| Device Name: | PATIENT EXAMINATION GLOVE (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | AMBUSCO CO., INC. 14 DELTA DR. New City, NY 10956 |
| Contact | Oliver Chiang |
| Correspondent | Oliver Chiang AMBUSCO CO., INC. 14 DELTA DR. New City, NY 10956 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-02 |
| Decision Date | 1989-08-09 |