Cleared Traditional

DISPOSABLE SURGICAL MASK (MODIFIED) (K931580) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 606
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K931580.
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops
K251967 · O&M Halyard, Inc. · Mar 2026
Surgical Face Mask (Ear mount)
K252534 · Zhejiang Hangkang Medical Equipment Co., Ltd. · Mar 2026
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
K253398 · Efofex, Inc. · Feb 2026
Disposable Surgical Face Mask (3P00B, C2900)
K252830 · Beatles Medical Supplies (Xiantao) Co., Ltd. · Jan 2026
Disposable Medical Face Mask
K252650 · Makrite Industries, Inc. · Jan 2026
KP Protective Face Mask
K243342 · Kp Trading Co., Ltd. · Dec 2025