Name: Predicase
Price: 199 USD

K-number	K173258
Device name	Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy
Applicant	Pt. Medisafe Technologies
Product code	KGO
Device class	Class I
Decision date	Apr 20, 2018
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy

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