Name: Predicase
Price: 199 USD

K-number	K021065
Device name	PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM
Applicant	Primus Gloves Private , Ltd.
Product code	KGO
Device class	Class I
Decision date	May 8, 2002
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM

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