The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Ansell No Powder Surgeon's Gloves.
| Device ID | K850635 |
| 510k Number | K850635 |
| Device Name: | ANSELL NO POWDER SURGEON'S GLOVES |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-06-26 |