Name: Predicase
Price: 199 USD

K-number	K214074
Device name	Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs
Applicant	Hartalega NGC Sdn. Bhd.
Product code	KGO
Device class	Class I
Decision date	May 26, 2022
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 Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs

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