Name: Predicase
Price: 199 USD

K-number	K202401
Device name	Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein
Applicant	Eco Medi Glove Sdn. Bhd.
Product code	KGO
Device class	Class I
Decision date	Feb 17, 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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Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein

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