Name: Predicase
Price: 199 USD

K-number	K193121
Device name	GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
Applicant	Eco Medi Glove Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Mar 20, 2020
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims

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