The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Sterile Exam Gloves.
| Device ID | K892106 |
| 510k Number | K892106 |
| Device Name: | STERILE EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ANSELL, INC. INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan, AL 36302 |
| Contact | Bradley L Pugh |
| Correspondent | Bradley L Pugh 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 |