HPI SENSI-SHIELD GLOVE KIT

Surgeon's Gloves

HPI, INC.

The following data is part of a premarket notification filed by Hpi, Inc. with the FDA for Hpi Sensi-shield Glove Kit.

Pre-market Notification Details

Device IDK910383
510k NumberK910383
Device Name:HPI SENSI-SHIELD GLOVE KIT
ClassificationSurgeon's Gloves
Applicant HPI, INC. 64 MYRTLE ST. West Newton,  MA  02165
ContactImogene Tibbets
CorrespondentImogene Tibbets
HPI, INC. 64 MYRTLE ST. West Newton,  MA  02165
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-30
Decision Date1991-03-20

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