The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Non-sterile Exam Gloves.
| Device ID | K892325 |
| 510k Number | K892325 |
| Device Name: | NON-STERILE EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ANSELL, INC. INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan, AL 36302 |
| Contact | Michael Englert |
| Correspondent | Michael Englert ANSELL, INC. INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan, AL 36302 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-05-31 |