Name: Predicase
Price: 199 USD

K-number	K192954
Device name	Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
Applicant	Comfort Rubber Gloves Industries Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Jun 19, 2020
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl

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