Cleared Special

K021076 - PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307

Also marketed or referenced as:
PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308 PRM

K021076 is an FDA 510(k) clearance for PRIMAGARD YELLOW SURGICAL MASK, manufactured by Primeline Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Special 510(k) pathway after a 13-day FDA review.

K021076 · Primeline Medical Products, Inc. · General Hospital
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Apr 2002
Decision
13d
Days
Class 2
Risk

K021076 is an FDA 510(k) clearance for the PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Primeline Medical Products, Inc. (Edmonton, Alberta, CA). The FDA issued a Cleared decision on April 16, 2002 after a review of 13 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K021076

510(k) Number K021076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2002
Decision Date April 16, 2002
Days to Decision 13 days
Submission Type Special
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
116d faster than avg
Panel avg: 129d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

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 564
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K021076.
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
DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
K021546 · Creative Contract (M) Sdn Bhd · Mar 2003
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
WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)
K001892 · White Knight Healthcare, Inc. · Apr 2001
K021076 · PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307
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