Name: Predicase
Price: 199 USD

K-number	K013324
Device name	HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT
Applicant	Tillotson Healthcare Corp.
Product code	KGO
Device class	Class I
Decision date	Nov 29, 2001
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT

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