| 許可證詳細內容 | 詳細處方成分 | 藥物外觀描述 | 仿單詳細內容 | 離 開 |
| ＊＊＊ 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 | 詳細處方成分 | 藥物外觀描述 | 仿單詳細內容 | 離 開 |
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]
| 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 |
本頁最後修改日期： 04/23/2008 02:53:15
回勞工安全衛生研究所首頁
全站熱搜
留言列表
