經美國NIOSH認證核可之拋棄式及部份半面式口罩列表－手帳

許可證詳細內容

＊＊＊衛署醫器輸壹字第005295號＊＊＊
註銷狀態		註銷日期
註銷理由
有效日期	100/11/02	發證日期	95/11/02
許可證種類	醫　器
舊證字號		醫療器材級數	第一等級
中文品名	"安發" N-95 醫用口罩 (未滅菌)
英文品名	Alpha N-95 Particulate Respirator (non-sterile)
效能	限醫療器材管理辦法「醫療用衣物(I.4040)」第一等級鑑別範圍。
醫器規格
劑型
醫器主類別	I一般及整型外科手術裝置	醫器次類別	I4040醫療用衣物
包裝
限制項目	02輸　入
藥理分類
申請商名稱	6201027050 美德耐股份有限公司
申請商地址	臺北市大安區光復南路458號14樓之1
主製造廠
製造廠名稱	M462220000 ALPHA PRO TECH, INC.
製造廠廠址	#903 WEST CENTER STREET, BLDG E, NORTH SALT LAKE UTAH 84054, U.S.A.
製造廠公司地址
製造廠國別	UNITED STATES	製程

許可證詳細內容

經美國NIOSH認證核可之拋棄式及部份半面式口罩列表

NIOSH計畫名稱 : 84A - Particulate Filter Respirators (Part 84)

N95以上等級防塵口罩 (Particulate Filtering)

型式：可拋棄式(Filtering facepiece)，半面式(Half mask)[半面式為台灣廠商製品]

依核准序號字母排列

Approval #	製造商名稱	商品貨號（Product Line）	認證型號
6	3M Company	1860	拋棄式
7	3M Company	8110S, 8210, 8216, 8217, 7048	拋棄式
8	3M Company	N95	拋棄式
454	3M Company	8212 or 8214 respirator	拋棄式
455	3M Company	8222	拋棄式
722	3M Company	8241	拋棄式
1166	3M Company	8271, 8276, 8277, 8576, 8577 respirator	拋棄式
1298	3M Company	model 8233	拋棄式
1299	3M Company	model 8511, 8516, 8517, 8616, 8617, 8211	拋棄式
1350	3M Company	8240, 8246 and 8247 respirators	拋棄式
2561	3M Company	Model 8293	拋棄式
2666	3M Company	9271 P95	拋棄式
2667	3M Company	9270 P95	拋棄式
2668	3M Company	9211 N95	拋棄式
2669	3M Company	9210 N95	拋棄式
3844	3M Company	Model 1870 filtering facepiece	拋棄式
3981	3M Company	Model 8000 N95 filtering facepiece without an exhalation valve	拋棄式
1348	Aearo Corporation	Pockits w/FFM-82 filter	拋棄式
2459	Aearo Corporation	R8210 or N9501C	拋棄式
2495	Aearo Corporation	N9502	拋棄式
2630	Aearo Corporation	Pleats N95	拋棄式
2655	Aearo Corporation	Pockits 51232, 51233, 51234 w/FFM-82 filter	拋棄式
2656	Aearo Corporation	Pockits 51241, 51242, 51243	拋棄式
2657	Aearo Corporation	Pockits 51244, 51245, 51246	拋棄式
2924	Aearo Corporation	R9502C	拋棄式
2934	Aearo Corporation	N9500CM	拋棄式
3318	Aearo Corporation	N9501C-OVAG	拋棄式
3715	Aearo Corporation	N9504C	拋棄式
3982	Aearo Corporation	Model N9506C filtering facepiece without an exhalation valve	拋棄式
12257	Aearo Corporation	N9504CS	拋棄式
457	Alpha Pro-Tech	MAS 695	拋棄式
2022	Aswan International Corp.	Aswan M-12	拋棄式
3165	Draeger Safety AG & Co. KGaA	Piccola 6737490	拋棄式
3166	Draeger Safety AG & Co. KGaA	Piccola 6737492	拋棄式
3172	Draeger Safety AG & Co. KGaA	Piccola 6737491	拋棄式
1349	Ekonic Company, Ltd.	EK2000	拋棄式
3015	Elephant Prince Co., Ltd.	EP-361 and EP-521	拋棄式
3888	Jinfufu Industrial Co., Ltd.	4150 N95 filtering facepiece without an exhalation valve	拋棄式
3889	Jinfufu Industrial Co., Ltd.	Model 4151 N95 filtering facepiece with an exhalation valve	拋棄式
3890	Jinfufu Industrial Co., Ltd.	Model 4190 N99 filtering facepiece without an exhalation valve	拋棄式
3907	Jinfufu Industrial Co., Ltd.	4191 N99 filtering facepiece respirator with an exhalation valve.	拋棄式
5	Kimberly-Clark Corporation	PFR95 or Preventer95	拋棄式
10	Kimberly-Clark Corporation	PFR95 and Preventer95	拋棄式
11	Kimberly-Clark Corporation	PFR95 and Preventer95	拋棄式
299	Kimberly-Clark Corporation	PFR95-110 and PFR95-210	拋棄式
160	Louis M. Gerson Company, Inc.	1730, 1731, 2734, 2735, 2737, 2734-OV, 2735-OV, 2737-OV2734-OV/AG, 2735-OV/AG, 2737-OV/AG	拋棄式
161	Louis M. Gerson Company, Inc.	1740, 1741, 2744, 2745, 2747, 2747OV/AG	拋棄式
204	Louis M. Gerson Company, Inc.	1750 and 1751	拋棄式
383	Louis M. Gerson Company, Inc.	1840	拋棄式
384	Louis M. Gerson Company, Inc.	1830	拋棄式
664	Louis M. Gerson Company, Inc.	1760 and 1761 disposable	拋棄式
2894	Louis M. Gerson Company, Inc.	model 2940	拋棄式
2898	Louis M. Gerson Company, Inc.	model 2767	拋棄式
3159	Louis M. Gerson Company, Inc.	Model 3935 filtering facepiece	拋棄式
3289	Louis M. Gerson Company, Inc.	model 3955	拋棄式
3290	Louis M. Gerson Company, Inc.	model 3965	拋棄式
3323	Makrite Industries, Inc.	910-N95 and 910-N95OV	拋棄式
3904	Makrite Industries, Inc.	N95-910V	拋棄式
1	Mine Safety Appliance Company	APR-3-N95-1	拋棄式
16	Mine Safety Appliance Company	APR-7-N95-0	拋棄式
29	Mine Safety Appliance Company	APR-7-N95-1	拋棄式
230	Mine Safety Appliance Company	Affinity N95	拋棄式
326	Mine Safety Appliance Company	Affinity N99	拋棄式
329	Mine Safety Appliance Company	RX-2/N95-2	拋棄式
385	Mine Safety Appliance Company	7R951	拋棄式
453	Mine Safety Appliance Company	7N951-NOV or RX-Laser Plume	拋棄式
456	Mine Safety Appliance Company	RX-1 or N95-1	拋棄式
547	Mine Safety Appliance Company	Affinity N95 w/nuisance OV	拋棄式
955	Mine Safety Appliance Company	7N100-2	拋棄式
981	Mine Safety Appliance Company	5N95-2	拋棄式
982	Mine Safety Appliance Company	5N95-2-NOV	拋棄式
983	Mine Safety Appliance Company	5N95-2-NOV-HD	拋棄式
984	Mine Safety Appliance Company	5N95-2-AG/HF	拋棄式
1018	Mine Safety Appliance Company	5N95-1	拋棄式
1019	Mine Safety Appliance Company	5N95-1-NOV	拋棄式
1020	Mine Safety Appliance Company	5N95-1-NOV-HD	拋棄式
1021	Mine Safety Appliance Company	5N95-1-AG/HF	拋棄式
1457	Mine Safety Appliance Company	Affinity Ultra	拋棄式
1458	Mine Safety Appliance Company	Affinity Ultra	拋棄式
2005	Mine Safety Appliance Company	MSA 5-1081-1	拋棄式
2015	Mine Safety Appliance Company	7-1588-1 Filtering Facepiece	拋棄式
2016	Mine Safety Appliance Company	7-1589-1 Filtering Facepiece	拋棄式
2021	Mine Safety Appliance Company	7-1590-1 Filtering Facepiece	拋棄式
2111	Mine Safety Appliance Company	7-1562-1	拋棄式
2659	Mine Safety Appliance Company	PPL-N95-2 (PITA PLUS & PITA VISION PLUS)	拋棄式
2665	Mine Safety Appliance Company	Affinity Pro and Affinity Plus	拋棄式
2680	Mine Safety Appliance Company	AFFINITY PLUS and PRO 7-1689-1	拋棄式
2681	Mine Safety Appliance Company	AFFINITY PLUS and PRO 7-1690-1	拋棄式
2718	Mine Safety Appliance Company	7-1691-1 P95 Affinity Pro and Affinity Plus	拋棄式
3156	Mine Safety Appliance Company	FR200 Affinify Foldable	拋棄式
3161	Mine Safety Appliance Company	FR201 Affinifty Foldable	拋棄式
3162	Mine Safety Appliance Company	FR211 Affinifty Foldable	拋棄式
3163	Mine Safety Appliance Company	FR401 Affinifty Foldable	拋棄式
3164	Mine Safety Appliance Company	FR411 Affinifty Foldable	拋棄式
13	Moldex-Metric, Inc.	2001; 2011; 2021, 1501;1503; 1511; 1513; 1521, 2601N95, 2600N95, 2607N95	拋棄式
120	Moldex-Metric, Inc.	2051 and 2052; 2701N95, 2700N95, and 2707N95; 2071 and 2072	拋棄式
327	Moldex-Metric, Inc.	2200N95 and 2200N95+	拋棄式
328	Moldex-Metric, Inc.	2300N95, 2307N95, 2300N95+, 2307N95+	拋棄式
872	Moldex-Metric, Inc.	2101R95	拋棄式
873	Moldex-Metric, Inc.	2111R95 w/ mini flange	拋棄式
874	Moldex-Metric, Inc.	2121R95 w/ full flange	拋棄式
875	Moldex-Metric, Inc.	2400N99	拋棄式
883	Moldex-Metric, Inc.	2400N95	拋棄式
942	Moldex-Metric, Inc.	2300R95	拋棄式
1456	Moldex-Metric, Inc.	model 2410	拋棄式
1459	Moldex-Metric, Inc.	model 2310	拋棄式
2006	Moldex-Metric, Inc.	2500	拋棄式
2023	Moldex-Metric, Inc.	2420	拋棄式
2438	Moldex-Metric, Inc.	2207N95, 2207N95+	拋棄式
2455	Moldex-Metric, Inc.	2301N95, 2301N95+	拋棄式
2456	Moldex-Metric, Inc.	2201N95, 2201N95+	拋棄式
2558	Moldex-Metric, Inc.	2200P95	拋棄式
2559	Moldex-Metric, Inc.	2300P95	拋棄式
2560	Moldex-Metric, Inc.	2310P95	拋棄式
3002	Moldex-Metric, Inc.	2800N95 and 2801N95	拋棄式
3014	Moldex-Metric, Inc.	2700P95 and 2701P95	拋棄式
3105	Moldex-Metric, Inc.	2820P95	拋棄式
3143	Moldex-Metric, Inc.	2700N100 or 2701N100	拋棄式
3167	Moldex-Metric, Inc.	1400N95, 1401N95	拋棄式
3168	Moldex-Metric, Inc.	1300N95, 1301N95	拋棄式
3174	Moldex-Metric, Inc.	model 2940R95 and 2941R95	拋棄式
3321	Moldex-Metric, Inc.	2840R95 and 2841R95	拋棄式
3330	Moldex-Metric, Inc.	Model 2640R95 and 2641R95	拋棄式
3331	Moldex-Metric, Inc.	Model 2740R95 and 2741R95	拋棄式
3743	Moldex-Metric, Inc.	Model EZ 15 and EZ 15S, EZ 22, EZ 22S	拋棄式
3846	Moldex-Metric, Inc.	EZ23 and EZ 23S	拋棄式
3902	MSA do Brasil Equipamentos e Instrumentos de Seguranca Ltda.	Affinity Plus p/n 216023 without ex.valve	拋棄式
3903	MSA do Brasil Equipamentos e Instrumentos de Seguranca Ltda.	Affinity Plus p/n 216114 with ex.valve	拋棄式
3723	North Safety Products	7130N95	拋棄式
3848	North Safety Products	RP1840 P95 filtering facepiece	拋棄式
3713	San Huei United Company Ltd.	SH9550C, SH9550, SH9550A	半面式
3714	San Huei United Company Ltd.	SH9550V, SH9550CV	半面式
3718	San Huei United Company Ltd.	SH2950, SH2950C and SH295A	半面式
3729	San Huei United Company Ltd.	SH2950V, SH2950CV	半面式
1025	San Huei United Company, Ltd.	SH3810	拋棄式
1026	San Huei United Company, Ltd.	SH3820	拋棄式
2882	San Huei United Company, Ltd.	SH3810V	拋棄式
3170	San Huei United Company, Ltd.	SH8650	拋棄式
3171	San Huei United Company, Ltd.	SH8650V and SH8650CV	拋棄式
3322	San Huei United Company, Ltd.	SH2760	拋棄式
3348	San M Package Co., Ltd.	models TN01-11 and TN01-12	拋棄式
301	Survivair, Inc.	1930 and 1940 disposable respirator	拋棄式
3347	Survivair, Inc.	model 1910	拋棄式
3349	Survivair, Inc.	model 1913	拋棄式
2011	U.S. Safety	Softseal-D model ADN95V	拋棄式
2012	U.S. Safety	Softseal-D model ADN95	拋棄式
1090	Willson ?Dalloz Safety Products	N9520, N9520-OV, N9520-AG, S, M, L	拋棄式
1164	Willson ?Dalloz Safety Products	N9501 S, M, L	拋棄式
1165	Willson ?Dalloz Safety Products	N9510 S, M, L	拋棄式
1238	Willson ?Dalloz Safety Products	N9930 sm, med, lg	拋棄式
1320	Willson ?Dalloz Safety Products	R9520M or R9520L	拋棄式
2312	Willson ?Dalloz Safety Products	1410N95	拋棄式
2679	Willson ?Dalloz Safety Products	P-9510	拋棄式
2883	Willson ?Dalloz Safety Products	model N9520F	拋棄式
2884	Willson ?Dalloz Safety Products	model N9510F	拋棄式
3745	Willson ?Dalloz Safety Products	N1125-OV, N1125-AG, N1125	拋棄式
3769	Willson ?Dalloz Safety Products	N1115S, N1115M/L, N1115XL	拋棄式
3789	Willson ?Dalloz Safety Products	N1105S, N1105M/L, N1105XL	拋棄式
3845	Willson ?Dalloz Safety Products	N1139 S, M/L, XL	拋棄式
3876	Willson ?Dalloz Safety Products	Saf-T-Fit Flatfold - models N9510TFM and N9510TFL	拋棄式
3877	Willson ?Dalloz Safety Products	Saf-T-Fit models P1115 M/L and P1115 XL	拋棄式
3879	Willson ?Dalloz Safety Products	1000 Series P1135 M/L, P1135 XL	拋棄式
3880	Willson ?Dalloz Safety Products	SAF-T-FIT flatfold models 9505TFM, 9505TFL	拋棄式