Name: Predicase
Price: 199 USD

K-number	K160467
Device name	Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
Applicant	Kossan International Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Aug 2, 2016
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 →

Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim

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