Name: Predicase
Price: 199 USD

K-number	K230217
Device name	Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
Applicant	Grand Work Plastic Products Co., Ltd.
Product code	KGO
Device class	Class I
Decision date	May 13, 2023
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs

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