Name: Predicase
Price: 199 USD

K-number	K232039
Device name	Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Applicant	Grand Work Plastic Products Co., Ltd.
Product code	LZA
Device class	Class I
Decision date	Aug 9, 2023
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

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