Name: Predicase
Price: 199 USD

K-number	K172942
Device name	Pristeen (Latex Surgeons Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein
Applicant	Beta Healthcare Products Pvt., Ltd.
Product code	KGO
Device class	Class I
Decision date	Jan 8, 2018
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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Pristeen (Latex Surgeons Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein

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

Pristeen (Latex Surgeons Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein