DERMA PRENE
Surgeon's Gloves
ANSELL, INC.
The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Derma Prene.
Pre-market Notification Details
| Device ID | K820665 |
| 510k Number | K820665 |
| Device Name: | DERMA PRENE |
| 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 | 1982-03-11 |
| Decision Date | 1982-05-03 |
Trademark Results [DERMA PRENE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DERMA PRENE 73397001 1275979 Live/Registered |
Ansell Incorporated 1982-09-30 |
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