Name: Predicase
Price: 199 USD

K-number	K190632
Device name	Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein
Applicant	Lenora Glove Pvt , Ltd.
Product code	KGO
Device class	Class I
Decision date	Oct 24, 2019
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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Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein

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

Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein