NON-STERILE PATIENT EXAMINATION GLOVES

Latex Patient Examination Glove

SUPERIOR HEALTHCARE GROUP, INC.

The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for Non-sterile Patient Examination Gloves.

Pre-market Notification Details

Device IDK905755
510k NumberK905755
Device Name:NON-STERILE PATIENT EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland,  RI  02864
ContactMaureen G Mccabe
CorrespondentMaureen G Mccabe
SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland,  RI  02864
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-27
Decision Date1991-03-08

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