CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES

Latex Patient Examination Glove

ANSELL PERRY

The following data is part of a premarket notification filed by Ansell Perry with the FDA for Conform No Powder (protein Labeling Claim) Examination Gloves.

Pre-market Notification Details

Device IDK972785
510k NumberK972785
Device Name:CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
ClassificationLatex 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 CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-25
Decision Date1997-09-19
Summary:summary

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