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510(k) Premarket Notification

mask, surgical 510(k) Number K182514 Device Name Surgical Face Mask Applicant Xiantao Zhibo Non-woven Products Co., Ltd NO.8 in Industrial Park, Hefeng Road xiantao, CN 430000 Applicant Contact ... MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. For Government; For Press; Combination Products;

510(k) Premarket Notification

Device Classification Name mask, surgical 510(k) Number K173062 Device Name Non Woven Face Mask (Models VQN0185W (earloop) and VQN0185B (ties)) Applicant

510(k) Premarket Notification - accessdata.fda.gov

3m™ high fluid-resistant surgical mask and 3m™ high fluid-resistant procedure mask 3M Health Care K191355 09/11/2019 surgical face mask Wuhan Dymex Healthcare Co., Ltd K182515 05/27/2019 surgical face mask Xiantao Zhibo Non-woven Products Co., Ltd K182514 01/24/2019

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(Mask, Surgical) - FDA 510(k) Applications Database

223 rows · hong ya non-woven products , ltd. surgical face mask 02/16/2005 k060776 hong ya …

FDA 510(K) NUMBERAPPLICANTDEVICE NAMEDECISION DATEK9101823M COMPANY3M BRAND EAR LOOP FACE MASK, 20…03/04/1991K9553823M COMPANY3M MODEL 1860 HEALTH CARE PARTI…05/01/1996K9407073M COMPANY3M SURGICAL MASK WITH FACE SHEILD05/23/1994K8816183M COMPANYASEPTEX 1809 FLUID-RESISTANT MOL…05/09/1988See all 223 rows on 510k.medevnet

510(k) Premarket Notification

Date Received 11/18/2004 Decision Date 02/16/2005 Decision substantially equivalent (SESE) Regulation Medical Specialty General & Plastic Surgery

510(k) Summary - Food and Drug Administration

Common Name Surgical Mask Classification Name Surgical Mask, 878.4040; Product Code FXX Predicate Device Surgical Mask 5 10(k) #K001951 Description of the Device These surgical masks are rectangular, waterfall-pleated or soft-bill devices manufactured from selected non-woven materials (polypropylene or wet-laid cellulose) designed to

Medical Gowns FDA

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Surgical mask manufacturers or importers are required to submit a 510(k) premarket notification to gain the FDA’s clearance to import and sell the products in the USA. There is a 90 lead time between submitting the 510(k) and being able to place the products on the market. A 510(k) will include the following (read the format from the FDA here):

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