PATIENT EXAMINATION GLOVES (LATEX)

Latex Patient Examination Glove

ANSELL PACIFIC, INC.

The following data is part of a premarket notification filed by Ansell Pacific, Inc. with the FDA for Patient Examination Gloves (latex).

Pre-market Notification Details

Device IDK892570
510k NumberK892570
Device Name:PATIENT EXAMINATION GLOVES (LATEX)
ClassificationLatex Patient Examination Glove
Applicant ANSELL PACIFIC, INC. 4750 SOUTH PARK AVE. Tucson,  AZ  85714
ContactFred Dietsch
CorrespondentFred Dietsch
ANSELL PACIFIC, INC. 4750 SOUTH PARK AVE. Tucson,  AZ  85714
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-10
Decision Date1989-07-14

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