Name: Predicase
Price: 199 USD

K-number	K200897
Device name	Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
Applicant	Hartalega Sdn Bhd
Product code	KGO
Device class	Class I
Decision date	Jun 1, 2020
Decision	Substantially Equivalent
Regulation	878.4460

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)

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