AMMEX LATEX EXAMINATION GLOVES

Latex Patient Examination Glove

AMMEX CORP.

The following data is part of a premarket notification filed by Ammex Corp. with the FDA for Ammex Latex Examination Gloves.

Pre-market Notification Details

Device IDK891850
510k NumberK891850
Device Name:AMMEX LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant AMMEX CORP. 1720-130TH AVE. N.E. SUITE 105 Bellevue,  WA  98005
ContactJeffrey Hummel
CorrespondentJeffrey Hummel
AMMEX CORP. 1720-130TH AVE. N.E. SUITE 105 Bellevue,  WA  98005
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-27
Decision Date1989-04-11

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