Name: Predicase
Price: 199 USD

K-number	K101820
Device name	NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES
Applicant	Yty Industry (Manjung) Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Mar 3, 2011
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES

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