Name: Predicase
Price: 199 USD

K-number	K070821
Device name	POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
Applicant	Medtexx Manufacturing Sdn. Bhd.
Product code	LYY
Device class	Class I
Decision date	May 10, 2007
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE

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