SURGICARE (R) LATEX EXAMINATION GLOVES

Latex Patient Examination Glove

INTER CONTINENTAL HEALTH CARE

The following data is part of a premarket notification filed by Inter Continental Health Care with the FDA for Surgicare (r) Latex Examination Gloves.

Pre-market Notification Details

Device IDK893651
510k NumberK893651
Device Name:SURGICARE (R) LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant INTER CONTINENTAL HEALTH CARE ATTN: DR. KRISHNA MENON 41 WOOD AVENUE Boston,  MA  02126
ContactSurgicare, Inc.
CorrespondentSurgicare, Inc.
INTER CONTINENTAL HEALTH CARE ATTN: DR. KRISHNA MENON 41 WOOD AVENUE Boston,  MA  02126
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-15
Decision Date1989-08-10

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