Name: Predicase
Price: 199 USD

K-number	K231029
Device name	Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
Applicant	Zhonghong Pulin Medical Products Co., Ltd.
Product code	LZA
Device class	Class I
Decision date	Oct 30, 2023
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl

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