Name: Predicase
Price: 199 USD

K-number	K151392
Device name	Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
Applicant	Terang Nusa Sdn Bhd
Product code	KGO
Device class	Class I
Decision date	Sep 18, 2015
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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Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less

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