Cleared Traditional

K933748 - SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD

K933748 is an FDA 510(k) clearance for SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD, 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 323-day FDA review.

K933748 · Bam Corp., Ltd. · General Hospital
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Jun 1994
Decision
323d
Days
Class 2
Risk

K933748 is an FDA 510(k) clearance for the SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD. 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 June 17, 1994 after a review of 323 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.

FDA 510(k) Submission Details - K933748

510(k) Number K933748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1993
Decision Date June 17, 1994
Days to Decision 323 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 129d · This submission: 323d
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 565
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K933748.
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K942475 · Protectaide, Inc. · Oct 1994
PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069
K942476 · Protectaide, Inc. · Oct 1994
3M SURGICAL MASK WITH FACE SHEILD
K940707 · 3M Company · May 1994
TECNOL PCM 2000
K932834 · Tecnol Medical Products, Inc. · May 1994
DISPOSABLE SURGICAL MASK (MODIFIED)
K931580 · Bam Corp., Ltd. · May 1994
K933748 · SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD
Download PDF Bam Corp., Ltd.