Name: Predicase
Price: 199 USD

K-number	K234097
Device name	Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Applicant	Ever Growth (Vietnam) Corporation Limited
Product code	LZA
Device class	Class I
Decision date	Mar 27, 2024
Decision	Substantially Equivalent
Regulation	880.6250

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

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