K-number	K970835
Device name	FACE MASK, SURGICAL MASK, NON-STERILE
Applicant	Tucker & Associates
Product code	FXX
Device class	Class II
Decision date	Sep 3, 1997
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 →

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 →

FACE MASK, SURGICAL MASK, NON-STERILE

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