Name: Predicase
Price: 199 USD

K-number	K170779
Device name	Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
Applicant	Terang Nusa Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	May 24, 2017
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein

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