Name: Predicase
Price: 199 USD

K-number	K191860
Device name	Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential
Applicant	Semperit Technische Produkte Gesellchaft M.B.H.
Product code	KGO
Device class	Class I
Decision date	Mar 31, 2020
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential

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

Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential