Cleared Traditional

K931580 - DISPOSABLE SURGICAL MASK (MODIFIED)

K931580 is an FDA 510(k) clearance for DISPOSABLE SURGICAL MASK (MODIFIED), manufactured by Bam Corp., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 398-day FDA review.

K931580 · Bam Corp., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
398d
Days
Class 2
Risk

K931580 is an FDA 510(k) clearance for the DISPOSABLE SURGICAL MASK (MODIFIED). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Bam Corp., Ltd. (Kowloon, HK). The FDA issued a Cleared decision on May 2, 1994 after a review of 398 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bam Corp., Ltd. devices

FDA 510(k) Submission Details - K931580

510(k) Number K931580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1993
Decision Date May 02, 1994
Days to Decision 398 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 129d · This submission: 398d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 465
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K931580.
BUSSE ISOLATION AND PROCEDURAL MASKS
K940720 · Busse Hospital Disposables, Inc. · Nov 1994
3M SURGICAL MASK WITH FACE SHEILD
K940707 · 3M Company · May 1994
TECNOL PCM 2000
K932834 · Tecnol Medical Products, Inc. · May 1994
FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR
K932137 · Tecnol Medical Products, Inc. · Apr 1994
BARRIER LASER PLUS FACE MASK
K934194 · Johnson & Johnson Medical, Inc. · Mar 1994
BARRIER EXTRA PROTECTION PLUS FACE MASK
K920108 · Johnson & Johnson Medical, Inc. · Feb 1994