Name: Predicase
Price: 199 USD

K-number	K202240
Device name	Disposable Surgical Mask/Fluid Resistant Procedure Mask
Applicant	Lhm Medical Technology (Hong Kong) Limited
Product code	FXX
Device class	Class II
Decision date	Feb 25, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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 →

Disposable Surgical Mask/Fluid Resistant Procedure Mask

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