Name: Predicase
Price: 199 USD

K-number	K202765
Device name	ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs
Applicant	Careplus (M) Sdn Bhd
Product code	KGO
Device class	Class I
Decision date	May 27, 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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ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs

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