The following data is part of a premarket notification filed by Ansell Pacific, Inc. with the FDA for Anatomical Examination Gloves.
| Device ID | K892579 |
| 510k Number | K892579 |
| Device Name: | ANATOMICAL EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ANSELL PACIFIC, INC. 4750 SOUTH PARK AVE. Tucson, AZ 85714 |
| Contact | Fred Dietsch |
| Correspondent | Fred Dietsch ANSELL PACIFIC, INC. 4750 SOUTH PARK AVE. Tucson, AZ 85714 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-10 |
| Decision Date | 1989-07-14 |