Name: Predicase
Price: 199 USD

K-number	K191800
Device name	Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim
Applicant	Kossan International Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Sep 16, 2019
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim

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