Name: Predicase
Price: 199 USD

K-number	K033564
Device name	POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2
Applicant	Kanam Latex Industries Pvt. , Ltd.
Product code	KGO
Device class	Class I
Decision date	Feb 24, 2004
Decision	Substantially Equivalent
Regulation	878.4460

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View the full FDA submission: accessdata.fda.gov

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POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2

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