Name: Predicase
Price: 199 USD

K-number	K021007
Device name	ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL
Applicant	Tillotson Healthcare Corp.
Product code	LYY
Device class	Class I
Decision date	Jul 5, 2002
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 →

ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL

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