Name: Predicase
Price: 199 USD

K-number	K211621
Device name	Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
Applicant	Careplus (M) Sdn Bhd
Product code	KGO
Device class	Class I
Decision date	Oct 6, 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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Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)

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