The following data is part of a premarket notification filed by Ansell Perry with the FDA for Elite Mark Iv Powder Free Polyurethane Synthetic Surgical Glove.
Device ID | K981392 |
510k Number | K981392 |
Device Name: | ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE |
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 | 1998-04-17 |
Decision Date | 1998-05-11 |
Summary: | summary |