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

K221196Disposable Medical Face Mask (ear Loop)Xiantao Topmed Nonwoven Protective Products Co., Ltd.
K221173Surgical Mask (Model: 0868F, 0866F)Jiangxi SanHao Medical Instruments Co.,Ltd
K221134Procedure Mask With Ear Loops And Surgical Mask With TiesSafeSource Direct, LLC
K220876AOK 95A Medical Mask (20200049)AOK Tooling Limited
K220824Medical Surgical Mask (Planar Type)Hunan Chopard Medical Devices Co., Ltd
K220749Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOPUnimax Medical Products Co., Ltd.
K2206373 Ply Medical Grade Single Use Procedural Disposable Face MaskKDI Med Supply
K220597Disposable Surgical Face Mask (FM-34EE,FM-44EE)Qingdao Bestex Rubber & Plastic Products Co.,Ltd.
K220377Procedure MaskLittle Rapids Corporation
K220378Sparta 3-Ply Surgical Disposable Face MaskSparta East, LLC
K220187Medical Surgical Mask (Model: JM92, JM92B)Guangdong Jia Mei Biological Technology Co.Ltd
K214094ROKI Surgical MaskROKI Co., Ltd.
K214087Medical Face MaskHubei Medlink Healthcare Co., Ltd
K214085Disposable Medical MaskHubei Wanli Protective Products Co. Ltd
K213970D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 PlyDanameco Medical Joint Stock Corporation

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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