Product Code: FXX


Products Classified as FXX

2812Mask, SurgicalSurgical Apparel.

Total Product Life Cycle (TPLC) Devices

2812Mask, SurgicalSurgical Apparel.

FDA Consensus Standards

Mask, Surgical [32728]21 CFR §878.4040 🔎
Mask, Surgical [37530]21 CFR §878.4040 🔎
Mask, Surgical [36979]21 CFR §878.4040 🔎

Pre-market Notifications for FXX

K211984MASC Surgical MaskMid-America Safety Corp.
K211861TAIJI Professional Series Level 3 Surgical Face MaskTaiji Medical Supplies, Inc.
K211497Surgical MaskHoneywell Safety Products
K211440ASM-301 Level 3 Surgical MaskAmerican Surgical Mask Company LLC
K211249Altor Safety 3-Ply Surgical Mask (Model:62222)Altor Safety LLC
K211042Disposable Procedural Ear-loop Face MaskChangzhou DSB Medical Co., LTD
K210970Single-Use Surgical Mask Model FE2311BBYD Precison Manufacturer Co., Ltd.
K210870MEO Med Disposable Medical Face MaskFujian MEO Medical Technology Limited
K210856Purism Disposable Surgical MaskChuzhou Daddy's Choice Science And Technology Co., Ltd.
K210815Disposable Face MaskBiobase Scientific (Shandong) Co., Ltd.
K210761Velguard Surgical Face MaskEstee Exports Health Care Division
K210767Surgical Masks, Model:FE-1Hunan Triplex Precision Medical Devices Co., Ltd
K210705Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3Defender Safety Inc.
K210524Surgical MaskChangzhou Holymed Products Co., Ltd.
K210429Disposable Surgical Face MaskJiangxi Heying Pharmaceutical Co., Ltd

Global Unique Device Identification Database

60368001105424Mask, Surgical
60368001105417Mask, Surgical
60368001105400Mask, Surgical
00368001105392Mask, Surgical
60368001105387Mask, Surgical
60368001105370Mask, Surgical
10366975013030Mask, Surgical
10366975013023Mask, Surgical
10366975012989Mask, Surgical
10366975012972Mask, Surgical
00366975002044Mask, Surgical
00366975002037Mask, Surgical
00366975002020Mask, Surgical
20366975000655Mask, Surgical
20366975000648Mask, Surgical

Maude Adverse Events

ULTRA FLUID RESISTANT MASKSCROSSTEX INTERNATIONAL INC.2020-03-19
FLUGUARD DISPOSABLE FACE MASK WITH ELASTIC EAR LOOPUNK2020-03-06
ULTRA? SENSITIVE EARLOOP MASKCROSSTEX INTERNATIONAL, INC. A CANTEL MEDICAL COMP2020-03-03
MASK,FACE,WHITE,HYPOALLERGENIC,FILTERMEDLINE INDUSTRIES INC.2020-02-28
COM-FIT? PLUSH MASKS CFP-3DENTSPLY LLC2020-02-12
COM-FIT? PLUSH MASKS CFP-3DENTSPLY LLC2020-02-12
COM-FIT? PLUSH MASKS CFP-3DENTSPLY LLC2020-02-12
COM-FIT? PLUSH MASKS CFP-3DENTSPLY LLC2020-02-12
COM-FIT? PLUSH MASKS CFP-3DENTSPLY LLC2020-02-12
MASK SURGICAL FOG FREE FOAMQUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.2020-01-27
MASK SURGICAL SENSITIVE WHITEQUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.2020-01-22
MASK SURGICAL SENSITIVE WHITEQUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.2020-01-13
COM-FIT SUPER SENSITIVE EAR LOOP WHITEDENTSPLY LLC2019-11-15
CROSSTEX ULTRA SENSITIVE EARLOOPCROSSTEX INTERNATIONAL INC.2019-10-23
COM-FIT SUPER SENSITIVE EAR LOOP WHITEDENTSPLY LLC2019-09-20
ANTI-FOG SURGICAL MASK, GREEN WITH FILM STRIPO&M HALYARD, INC.2019-07-12
FLUIDSHIELD* LEVEL 1 SURGICAL MASK WITH SO SOFT* LININGO&M HALYARD, INC.2019-07-11
FLUIDSHIELD* 3 FOG-FREE PROCEDURE MASK WITH SO SOFT* EARLOOPS, ORANGEO&M HALYARD, INC.2019-07-11
FLUIDSHIELD* LEVEL 1 SURGICAL MASK WITH SO SOFT* LININGO&M HALYARD, INC.2019-07-11
COM-FIT? PLUSH MASKS CFP-3DENTSPLY LLC2019-05-31
NATURAL EXTENSIONS EXTRA SENSITIVE EAR LOOP FACE MASKCROSSTEX INTERNATIONAL INC.2019-05-30
FLUIDSHIELDOM HALYARD, INC.2019-04-24
COM-FIT SUPER SENSITIVE EAR LOOP WHITEDENTSPLY LLC2019-04-10
MASK SURGICAL FOGFREE ANTI GLAREQUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.2019-04-08
MEDICHOICE PRIMAGARD80 TIE SOFT BILL GREENOWENS & MINOR DISTRIBUTION, INC.2019-03-20
MASK PROCEDURE YELLOWQUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.2019-03-17
FACE MASK,PROCEDURAL , EARLOOPS, BLUE,LFMEDLINE INDUSTRIES INC.2019-02-26
MASK, PROCEDUREQUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.2019-02-17
MEDICHOICE SURGICAL MASKOWENS & MINOR DISTRIBUTION, INC.2019-02-13
MASK SURG DUCKBILL SENSITIVE WHITEQUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.2019-02-11
LITE ONE SURGICAL MASK BLUE, 50O&M HALYARD, INC.2019-02-06
MASK,FACE,GREEN,CHAMBER,TIES,LFMEDLINE INDUSTRIES INC.2019-01-09
COM-FIT PLUSH NATURAL FIT MASKS ASTM 2DENTSPLY LLC2018-12-26
COM-FIT PLUSH NATURAL FIT MASKS ASTM 2DENTSPLY LLC2018-12-26
COM-FIT SUPER HIGH FILTRATION W/ SHIELD EAR LOOPDENTSPLY LLC2018-11-21
MEDICOM SAFEMASK PREMIER ELITEAMD MEDICOM INC.2018-10-24
LEVEL I SURGICAL MASK ANTI-FOG FOAM TIESCARDINAL HEALTH 200, LLC2018-10-04
COM-FIT SUPER HIGH FILTRATION MASKS EAR LOOP BLUEDENTSPLY LLC2018-09-26
COM-FIT SUPER HIGH FILTRATION MASKS EAR LOOP BLUEDENTSPLY LLC2018-09-26
COM-FIT SUPER HIGH FILTRATION MASKS EAR LOOP BLUEDENTSPLY LLC2018-09-26
FLUIDSHIELD N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASKHALYARD HEALTH INC.2018-09-24
MEDICOM SAFEMASK MASTER SERIESAMD MEDICOM INC.2018-09-21
PROCEDURE MASK WITH SO SOFT* EARLOOPS, YELLOWO&M HALYARD, INC.2018-09-21
MASK, SURGICAL SOFT-TOUCH SENSITIVE WHTQUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.2018-09-18
ULTRA SENSITIVE EARLOOP W/ SECURE FIT FACE MASKCROSSTEX INTERNATIONAL INC.2018-09-07
FLUIDSHIELD N95 PARTICULATE FILTER RESPIRATOR AND DUCKBILL SURGICAL MASKHALYARD HEALTH, INC.2018-08-28
MASK,FACE,MAX FLUID PROTECT,EARLOOPMEDLINE INDUSTRIES INC.2018-05-31
MASK, PROCEDURE, YELLOWQUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.2018-05-01
INST-GARD SURGICAL MASK W/FOG-FREE ADHESIVE TAPE, GREEN CONVERTORSCARDINAL HEALTH 200, LLC2018-04-25
MASK, PROCEDURE, BLUECARDINAL HEALTH 200 LLC2018-03-23

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