Name: Predicase
Price: 199 USD

K-number	K080520
Device name	NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
Applicant	Siam Sempermed Corp., Ltd.
Product code	LZA
Device class	Class I
Decision date	Apr 30, 2008
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM

Everything you need for a 510(k) submission. Nothing you don't.