The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Orthopedic Surgical Glove.
| Device ID | K831564 |
| 510k Number | K831564 |
| Device Name: | ORTHOPEDIC SURGICAL GLOVE |
| Classification | Patient Examination Glove |
| Applicant | ANSELL, INC. 1500 INDUSTRIAL RD. Dothan, AL 36303 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-16 |
| Decision Date | 1983-07-12 |