Name: Predicase
Price: 199 USD

K-number	K202003
Device name	Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
Applicant	Gmp Medicare Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Feb 24, 2021
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

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