Name: Predicase
Price: 199 USD

K-number	K003895
Device name	X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21
Applicant	Ansell Perry
Product code	KGO
Device class	Class I
Decision date	Jan 17, 2001
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21

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