K-numberK222266
Device nameSurgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
ApplicantJingzhou Haixin Green Cross Medical Products Co., Ltd.
Product codeFXX
Device classClass II
Decision dateSep 26, 2022
DecisionSubstantially Equivalent
Regulation878.4040
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 →

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

14-day free trial. No setup. Cancel anytime.

Start free trial →
Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →