Name: Predicase
Price: 199 USD

K-number	K003872
Device name	GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Applicant	Guthrie Medicare Products (Melaka) Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Jan 23, 2001
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

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