Name: Predicase
Price: 199 USD

K-number	K230832
Device name	Powdered Free Sterile Natural Rubber Latex Surgical Gloves
Applicant	The Egyptian Company For Medical & Electronic Industries
Product code	KGO
Device class	Class I
Decision date	Aug 16, 2023
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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Powdered Free Sterile Natural Rubber Latex Surgical Gloves

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