Name: Predicase
Price: 199 USD

K-number	K203538
Device name	SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)
Applicant	Medline Industries, Inc.
Product code	KGO
Device class	Class I
Decision date	Aug 2, 2021
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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SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)

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