LOW POWDER SINGLE USE LATEX EXAM GLOVES

Latex Patient Examination Glove

PHOENIX MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Phoenix Medical Technology, Inc. with the FDA for Low Powder Single Use Latex Exam Gloves.

Pre-market Notification Details

Device IDK892975
510k NumberK892975
Device Name:LOW POWDER SINGLE USE LATEX EXAM GLOVES
ClassificationLatex Patient Examination Glove
Applicant PHOENIX MEDICAL TECHNOLOGY, INC. HWY. 521 WEST, P.O. BOX 346 Andrews,  SC  29510
ContactJ. F Sauve'
CorrespondentJ. F Sauve'
PHOENIX MEDICAL TECHNOLOGY, INC. HWY. 521 WEST, P.O. BOX 346 Andrews,  SC  29510
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-12
Decision Date1989-06-19

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