ClearanceBrief
Panels › General, Plastic Surgery › Product code FXX · Class 2

Mask, Surgical

Regulation 878.4040

7510(k)s in 12 months (607 all time)
0recalls in 12 months (12 all time)
10recalls that name a 510(k)
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Top companies in FXX

Company510(k)sRecalls
Tecnol New Jersey Wound Care, Inc.110
Owens & Minor (O&M) Halyard, Inc.80
Anago, Inc.70
Protectaide, Inc.70
3M Company60
Guangdong Kingfa Sci. & Tech.Co., Ltd.60
AMD Medicom Inc.05
Tecnol Medical Products, Inc.50
Dukal Corp.40
Kimberly-Clark40
Decided510(k)Device and applicantCode
Mar 24, 2015K143287Fluidshield* Surgical Mask with Expanded Chamber
Halyard Health, Inc.
FXX
Mar 4, 2015K142990Insta-Gard Surgical and Procedure Face Mask
Cardinal Health200, LLC
FXX
Jun 20, 2014K140155SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
Cardinal Health200, LLC
FXX
Dec 20, 2013K131879KC 300 SURGICAL MASK
Kimberly-Clark Corp.
FXX
Jul 17, 2013K123787GREENCROSS SURGICAL MASK
Jingzhou Haixin Green Cross Medical Products Co.,L
FXX
May 20, 2013K123115ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
Acme Filter Mask, Inc., TW
FXX
Dec 21, 2012K122717FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
Tiger Medical Products, Ltd., CN
FXX
Oct 20, 2011K111402KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
Kimberly-Clark
FXX
Oct 6, 2011K111343CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
Crosstex International, Inc.
FXX
Sep 16, 2011K111559SURGICAL MASKS
Shanghai Neo-Medical Import & Export Co., Ltd., CN
FXX
Aug 5, 2011K110027SURGICAL FACE MASK; SURGICAL FACE MASK
Angeline Group , Ltd., TW
FXX
Apr 29, 2011K110455KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
Kimberly-Clark Corp.
FXX
Jan 25, 2011K102713TIGER FLAT SURGICAL MASK
Tiger Medical Products, Ltd., CN
FXX
Dec 23, 2010K103303CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE
Crosstex International, Inc.
FXX
Sep 10, 2010K093901SURGICAL FACE MASK
Epard Protective Products, Ltd.
FXX
Aug 16, 2010K100846IMC SURGICAL FACE MASK
International Medsurg Connection
FXX
Aug 9, 2010K101000WELLMIEN SURGICAL MASK
Wellmien (Suzhou) Import & Export Trading Co., Ltd.
FXX
Jul 14, 2010K093179MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)
H&H Research Company
FXX
Jun 14, 2010K100800TIDI FACEMASK
Tidi Products,Llc
FXX
Feb 23, 2010K092580TIDI FACEMASK
Tidi Products,Llc
FXX
Sep 25, 2009K092012PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
Primed Medical Products, Inc., CA
FXX
Oct 16, 2008K082258CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR
Crosstex International
FXX
Aug 11, 2008K081633PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS
Primed Medical Products, Inc., CA
FXX
Mar 26, 2007K070407DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE
Dukal Corp.
FXX
Mar 21, 2007K063043SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
Modern Healthcare Corp., TW
FXX
Sep 15, 2006K061864DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560
Dukal Corp.
FXX
Aug 14, 2006K061716PRESTIGE AMERITECH FACE MASK
Prestige Ameritech
FXX
May 25, 2006K060776SURGICAL FACE MASK
Hong YA Non-Woven Products Co., Ltd.
FXX
Oct 26, 2005K050689SURGICAL FACE MASK
China Surgical Dressings Center Co., Ltd., TW
FXX
Sep 20, 2005K051291NON-STERILE SURGICAL MASK
A.R. Medicom, Inc., CA
FXX
Feb 16, 2005K043199SURGICAL FACE MASK
Hong YA Non-Woven Products Co., Ltd.
FXX
Dec 17, 2004K042654PROTECTION PLUS EARLOOP PROCEDURE MASK
Safety-Med Products, Inc.
FXX
Dec 1, 2004K041047ULTRADENT CARBON MASK - UPI #342
Medspring Group, Incorporated
FXX
Jun 7, 2004K040333VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS
Valumax Intl., Inc.
FXX
Apr 26, 2004K022256SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
Tucker & Associates
FXX
Feb 20, 2004K034015EARLOOP PROCEDURE MASK
Medipack Medical Packaging Mfg. Co.
FXX
Jul 24, 2003K030239MEGATECH SCIENTIFIC FACE MASK
Megatech Scientific Pte, Ltd., SG
FXX
Jun 19, 2003K031353SOLUTION FACE MASKS
A Plus International, Inc.
FXX
Jun 10, 2003K023755WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD
Winner Industries (Shenzhen) Co., Ltd.
FXX
Mar 5, 2003K021546DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
Creative Contract (M) Sdn Bhd
FXX
Mar 5, 2003K021539DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS
Creative Contract (M) Sdn Bhd
FXX
Mar 5, 2003K021533DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)
Creative Contract (M) Sdn Bhd
FXX
Apr 16, 2002K021076PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM
Primeline Medical Products, Inc., CA
FXX
Jan 22, 2002K012602CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX
Crosstex Intl.
FXX
Jun 22, 2001K011789PROCEDURE MASKS: PM4-301 AND PM4-304
Primeline Medical Products, Inc., CA
FXX
Apr 3, 2001K001892WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)
White Knight Healthcare, Inc.
FXX
Apr 2, 2001K001997WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)
White Knight Healthcare, Inc.
FXX
Apr 2, 2001K001893WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
White Knight Healthcare, Inc.
FXX
Sep 8, 2000K001951PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306
Primeline Medical Products, Inc., CA
FXX
Jan 28, 2000K992604HENRY SCHEIN SURGICAL MASK
Mitsui Textile Corp.
FXX

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