STERILE LATEX EXAM 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 Sterile Latex Exam Gloves.

Pre-market Notification Details

Device IDK894676
510k NumberK894676
Device Name:STERILE LATEX EXAM GLOVES
ClassificationLatex Patient Examination Glove
Applicant SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland,  RI  02864
ContactPaul Bernard
CorrespondentPaul Bernard
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 Received1989-07-24
Decision Date1989-08-17

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