Name: Predicase
Price: 199 USD

K-number	K010961
Device name	X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant	Ansell Healthcare Products, Inc.
Product code	LYY
Device class	Class I
Decision date	May 31, 2001
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

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