Name: Predicase
Price: 199 USD

K-number	K172420
Device name	Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
Applicant	Wear Safe (Malaysia) Sdn. Bhd.
Product code	KGO
Device class	Class I
Decision date	Sep 29, 2017
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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Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim

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