The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Micro-thin Surgical Glove.
| Device ID | K831565 |
| 510k Number | K831565 |
| Device Name: | MICRO-THIN SURGICAL GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | ANSELL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-16 |
| Decision Date | 1983-07-19 |