The following data is part of a premarket notification filed by Ansell Perry with the FDA for Synsation Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves.
Device ID | K992156 |
510k Number | K992156 |
Device Name: | SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES |
Classification | Vinyl Patient Examination Glove |
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 | LYZ |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-25 |
Decision Date | 1999-10-27 |
Summary: | summary |