Name: Predicase
Price: 199 USD

K-number	K220545
Device name	Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
Applicant	Hl Rubber Industries Sdn Bhd
Product code	LZC
Device class	Class I
Decision date	May 26, 2022
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs

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