The following data is part of a premarket notification filed by Ansell Perry with the FDA for Elite Powder-free Polyurethane Synthetic Surgical Gloves (chemotherapy Use).
Device ID | K984559 |
510k Number | K984559 |
Device Name: | ELITE POWDER-FREE POLYURETHANE 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 |