Name: Predicase
Price: 199 USD

K-number	K012876
Device name	DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant	Wrp Specialty Products Sdn. Bhd.
Product code	LYY
Device class	Class I
Decision date	Oct 1, 2001
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

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