SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES

Vinyl Patient Examination Glove

ANSELL PERRY

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.

Pre-market Notification Details

Device IDK992156
510k NumberK992156
Device Name:SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
ClassificationVinyl Patient Examination Glove
Applicant ANSELL PERRY 1875 HARSH AVE. S.E. Massillon,  OH  44646 -7199
ContactJames R Chatterton
CorrespondentJames R Chatterton
ANSELL PERRY 1875 HARSH AVE. S.E. Massillon,  OH  44646 -7199
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-25
Decision Date1999-10-27
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.