Cleared Traditional

K021546 - DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR

K021546 is an FDA 510(k) clearance for DERMASSIST FLUID RESISTANT SURGICAL MAS..., manufactured by Creative Contract (M) Sdn Bhd. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K021546 · Creative Contract (M) Sdn Bhd · General Hospital
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Mar 2003
Decision
299d
Days
Class 2
Risk

K021546 is an FDA 510(k) clearance for the DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Creative Contract (M) Sdn Bhd (Sand Springs, US). The FDA issued a Cleared decision on March 5, 2003 after a review of 299 days - an extended review cycle.

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. Standard predicate reliance. 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 - K021546

510(k) Number K021546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2002
Decision Date March 05, 2003
Days to Decision 299 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
170d slower than avg
Panel avg: 129d · This submission: 299d
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 601
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K021546.
WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD
K023755 · Winner Industries (Shenzhen) Co., Ltd. · Jun 2003
DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)
K021533 · Creative Contract (M) Sdn Bhd · Mar 2003
DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS
K021539 · Creative Contract (M) Sdn Bhd · Mar 2003
PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307
K021076 · Primeline Medical Products, Inc. · Apr 2002
CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX
K012602 · Crosstex Intl. · Jan 2002
PROCEDURE MASKS: PM4-301 AND PM4-304
K011789 · Primeline Medical Products, Inc. · Jun 2001
K021546 · DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
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