Name: Predicase
Price: 199 USD

K-number	K182089
Device name	Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
Applicant	Platinum Glove Industries Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Jul 30, 2019
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 Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs

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