Name: Predicase
Price: 199 USD

K-number	K083305
Device name	POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM
Applicant	Wrp Asia Pacific Sdn. Bhd.
Product code	LZC
Device class	Class I
Decision date	Jun 18, 2009
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM

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