Name: Predicase
Price: 199 USD

K-number	K211750
Device name	Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)
Applicant	National Bridge Industrial (S.Z.) Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	Dec 20, 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 Face Mask, Disposable Surgical Face Mask (Sterile)

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