Name: Predicase
Price: 199 USD

K-number	K212408
Device name	Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
Applicant	Pt. Maja Agung Latexindo
Product code	LZA
Device class	Class I
Decision date	May 18, 2022
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)

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