Name: Predicase
Price: 199 USD

K-number	K002087
Device name	BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS)
Applicant	Qingdao Bestex Rubber & Plastic Products Co., Ltd.
Product code	LYY
Device class	Class I
Decision date	Sep 13, 2000
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS)

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