Name: Predicase
Price: 199 USD

K-number	K212898
Device name	Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs
Applicant	Rimba Glove Snd Bhd
Product code	LZA
Device class	Class I
Decision date	Dec 16, 2021
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs

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