Name: Predicase
Price: 199 USD

K-number	K192988
Device name	Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use
Applicant	Medline Industries, Inc.
Product code	KGO
Device class	Class I
Decision date	Apr 1, 2020
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use

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