Name: Predicase
Price: 199 USD

K-number	K211810
Device name	Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)
Applicant	Pt. Shamrock Manufacturing Corpora
Product code	LZA
Device class	Class I
Decision date	May 23, 2022
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)

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