Name: Predicase
Price: 199 USD

K-number	K220644
Device name	Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
Applicant	Yty Industry (Manjung) Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Mar 25, 2023
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs

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