The following data is part of a premarket notification filed by Eagle Medical, Inc. with the FDA for Disposable Latex Exam Gloves.
| Device ID | K891795 |
| 510k Number | K891795 |
| Device Name: | DISPOSABLE LATEX EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | EAGLE MEDICAL, INC. 11310 PALISADES CT. Kensington, MD 20895 |
| Contact | John L Wolf |
| Correspondent | John L Wolf EAGLE MEDICAL, INC. 11310 PALISADES CT. Kensington, MD 20895 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-23 |
| Decision Date | 1989-04-26 |