The following data is part of a premarket notification filed by Ansell Perry with the FDA for Derma Prene Powder-free Synthetic Surgical Gloves (chemotherapy Use).
| Device ID | K984558 |
| 510k Number | K984558 |
| Device Name: | DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) |
| Classification | Surgeon's Gloves |
| Applicant | ANSELL PERRY 1875 HARSH AVE. S.E. Massillon, OH 44646 -7199 |
| Contact | James R Chatterton |
| Correspondent | James R Chatterton ANSELL PERRY 1875 HARSH AVE. S.E. Massillon, OH 44646 -7199 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-23 |
| Decision Date | 1999-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20811220030807 | K984558 | 000 |
| 20811220030791 | K984558 | 000 |
| 20811220030784 | K984558 | 000 |
| 20811220030777 | K984558 | 000 |
| 20811220030760 | K984558 | 000 |
| 00811220030759 | K984558 | 000 |
| 20811220030746 | K984558 | 000 |
| 20811220030739 | K984558 | 000 |
| 50884908033538 | K984558 | 000 |