510(k) K014110

Device
SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT
Applicant
Siam Sempermed Corp., Ltd.
510(k) number
K014110
Product code
LYY
Decision
Substantially Equivalent (SESE)
Decision date
2002-02-28
Date received
2001-12-14
Regulation
880.6250
Classification name
Latex Patient Examination Glove
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
JAY MANSOUR
Address
1308 Morningside Park Dr. Alpharetta GA US 30022 30022

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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