美国FDA:因质量问题,撤销中国约60家制造商对美出口N95口罩许可
仪器信息网讯当地时间5月7日,美国食品和药物监督管理局(FDA,下称“美食药监局”)在官网向全体医护人员致信称,因一部分来自中国的口罩无法在新冠肺炎疫情期间起到足够的保护作用,他们已取消了一些中国制造商在美国销售N95口罩的许可。美食药监局表示,他们发现有60多家中国制造商的口罩质量不合格,因此将准许在美销售的中国口罩制造商数量由80家减少到14家。由于新冠肺炎疫情大流行的原因,个人防护用品的需求激增,N95口罩因为可以过滤至少95%的空气颗粒物,在疫情期间被美国疾病预防与控制中心(CDC,下称美疾控中心)列为重要的防护用品。美疾控中心下属的美国国家职业安全卫生研究所(NIOSH)最近在对67种不同类型的进口N95口罩进行检测后发现,有约六成产品的过滤效果未达到美国N95口罩标准。同时,NIOSH的测试还发现,7日被取消出口许可的一家中国公司的口罩只能过滤掉24%-35%的颗粒物,远低于N95口罩命名所要求的过滤95%颗粒物的标准,而这款口罩的包装上宣称过滤级别为五星级,并使用了未经授权的FDA标志。正因为上述情况,美食药监局决定取消多家中国制造商在美销售N95口罩的许可。这也意味着美食药监局推翻了4月3日所作出的一项决定(当时,他们允许一些未经美国政府检测的制造商出口口罩到美国,只要通过一家独立实验室的审查即可)。在迄今为止已从准许名单中删除的产品中,下列产品未能在NIOSH进行的测试中显示出至少95%的最小颗粒过滤效率:CTTCo.LtdDaddybabyCo.LtdDongguanXiandaMedicalEquipmentCo.,Ltd.GuangdongFeiFanMstarTechnologyLTDGuangdongNuokangMedicalTechnologyCo.,Ltd.HuizhouHuinuoTechnologyCo.,Ltd.LanshanShendunTechnologyCoNIOSH会定期更新其测试结果列表(文末附截至5月8日测试结果表)。在德国从事口罩进出口贸易的业内人士曾指出,新冠疫情爆发前,国际上没有对口罩质量标准的统一规定,也缺乏权威的质量认证机制,这才是最大问题所在。中国外交部发言人耿爽日前在记者会上表示,中方高度重视出口防疫医疗物资质量问题,近期商务部会同海关总署、药监局、市场监管总局已就有序开展医疗物资出口、加强质量监管出台了多项举措。防疫物资出口中出现的质量问题,很多是因为中外质量标准不同,使用习惯存在差异,外方未严格按照产品用途使用造成的。耿爽表示,中方将会继续严格执行监管政策,确保防疫物资出口质量,同时也希望外方加强采购商在进口环节的质量检测,并严格按照产品的适用范围和操作规程正确使用。附:NIOSH测试结果列表(截至5月8日更新)ManufacturerModelNumber/ProductLineInternationalStandardFiltrationEfficiency(%)TestReportMaximumMinimumAnhuiBaishidunProtectiveEquipmentCo.,Ltd.BaishidunFFP2EN149,GB262653.0046.102020-51.1pdficonAnhuiChangliEnvironmentalProtectionTechnologyCo.,LtdKN95ProtectiveMaskEN14995.7494.732020-50.1pdficonAnhuiHongqiaosiHometextileCo.,Ltd.KN95DisposableProtectiveFaceMaskUNKNOWN99.8099.642020-80.2pdficonAnhuiJinlingPlasticsCo.,Ltd.UNKNOWNGB262696.1377.602020-21.1pdficonAnhuiJinlingPlasticsCompanyLimitedProtectiveMaskEN14999.6698.672020-59.1pdficonAnhuiKangweijiaLaborProtectionArticlesCo.,Ltd.9501ProtectiveMaskEN149,GB262698.9292.052020-86.1pdficonAnhuiRYZURMedicalEquipmentManufacturingCo.,Ltd.KN95BEN149,GB262633.9027.002020-66.3pdficonAnHuiSuBoLunClothingCo.,Ltd.SUKN95GB262695.1028.452020-55.1pdficonBaojiTaidakangMedicalTechnologyCo.,LtdMedicalProtectiveMaskGB1908399.2794.302020-47.1pdficonChangningLingjiakangProtectiveProductsFactoryKN95StereoProtectiveMaskEN14950.7433.752020-10.3pdficonChangshuCityHengyunNonwovenProductsCo.,Ltd.KN95RespiratorMasksGB262697.2988.532020-78.3pdficonChunyuChunyuFFP2EN14999.0397.542020-06.1pdficonCTTCo.,Ltd.KN95(8410)EN149,GB262698.8385.702020-87.1pdficonCSICPacli(Nanjng)TechCo.Ltd.FilteredProtectiveMaskKN95GB262697.7296.742020-28.1pdficonDaddybabyCo.,Ltd.KN954-PLYEN14993.4591.152020-29.4pdficonDeltaPlusCA38.504ABNT/NBR1369899.4393.092020-45.2pdficonDobuLifeTechCo.,Ltd.Dobu#201KMOEL99.9499.852020-115.2pdficonDongguanOukangdaMedicalTechnologyCo.,Ltd.Self-PrimingFilterRespiratorGB262693.7620.002020-78.4pdficonDongguanOukangdaMedicalTechnologyCo.,Ltd.KangerdaKN95ParticulateRespiratorEN149,GB262693.6890.282020-78.5pdficonDongguanXiandaMedicalEquipmentCo.,Ltd.KN95ProtectiveMaskEN149,GB262635.0024.102020-23.1pdficonDongguanXiandaMedicalEquipmentCo.,Ltd.KN95ProtectiveMaskGB262699.6399.472020-120.1pdficonFlyhorseIndustrialCo.,Ltd.FL0616EN14992.5890.182020-75.1pdficonGaomiCityHanchengPersonalProtectiveProductsCo.,Ltd.Baokangjie9001GB262699.1598.192020-57.3pdficonGarryGalaxyBiotechnologyCo.,Ltd.RespiratorMaskWithTruToneTechnologyGB/T3261044.3035.202020-119.1pdficonGuangdongEnergyFortressPharmaceuticalCo.,Ltd.KN95ProtectiveRespiratorGB2626100.0095.362020-77.2pdficonGuangdongFeiFanMstarTechnologyLTDPurvigorKN95EN149,GB262668.8361.602020-10.2pdficonGuangdongMedicalTechnologyCo.,Ltd.KN95StereoProtectiveMaskEN14999.1897.912020-102.1pdficonGuangdongNafeiIndustrialHoldingCo.,Ltd.EfficientNursingProtectiveMaskEN149,GB262610.501.102020-78.8pdficonGuangdongNafeiIndustrialHoldingCo.,Ltd.NAFYProtectiveMaskEN14920.4013.902020-63.1pdficonGuangdongNuokangMedicalTechnologyCo.,Ltd.KN95-CertifiedParticulateRespiratorGB262698.7324.222020-60.1pdficonGuangdongQianJingTestingCo.,LTD.DNWProtectiveMaskEN149,GB262676.5069.202020-18.1pdficonGuangdongShantouMachineryKN95MaskEN149,GB262649.0034.702020-37.1pdficonGuangdongZhizhenBiologicalMedicineCo.,Ltd.KN95Three-DimensionalProtectiveRespiratorGB262689.8088.702020-124.1pdficonGuangzhouBaoweikang(Powecom)PersonalProtectionEquipmentCo.,Ltd.KN95ProtectiveMaskGB262699.4099.212020-49.1pdficonGuangzhouHarleyCommodityCo.,Ltd.L-103VKN95GB262699.4999.022020-95.1pdficonGuangzhouHuashanBiotechnologyCo.,Ltd.GF-MaskKN95MaskGB262674.9027.102020-78.1pdficonGuangzhouKangbangMedicalEquipmentCo.,Ltd.KN95MaskEN14998.8672.002020-68.1pdficonGuangzhouSunjoyAutoSuppliesCo.,Ltd.K1SelfSuctionFilterRespiratorGB262643.7012.302020-118.1pdficonGuangzhouTianyiZhongliangBiotechnologyGroupCo.,Ltd.KN95DisposableProtectiveMaskGB262697.2987.202020-65.1pdficonGuanyangYuhanTextileCo.,Ltd.KN95ProtectiveFaceMaskGB262656.5942.152020-36.1pdficonHangzhouSenrunqingTechnologyCo.,Ltd.KN95Mask-CEN149,GB262685.9078.702020-67.1pdficonHenanKangMedicalDevicesCo.,Ltd.KN95ProtectiveMask–KS16GB262697.5052.102020-97.1pdficonHoneywellSafetyProducts(Shanghai)Co.,Ltd.H801ParticulateRespiratorGB262699.3298.402020-61.1pdficonHuabai9501GB262697.0769.002020-29.3pdficonHuizhouHuinuoTechnologyCo.,Ltd.HV-N9501B(Non-SterileMask)GB262696.5588.812020-22.2pdficonHuizhouHuinuoTechnologyCo.,Ltd.HV-NWhiteKN95GB262694.9890.582020-113.1pdficonHuizhouZhongnaMedicalTechnologyCo.,LtdAnysoundKN95Self-PrimingFilter&Anti-ParticleRespiratorEN149,GB262683.4177.302020-56.3pdficonJiandeChaomeiDailyChemicalsCo.,Ltd.CM9527GB1908399.2997.872020-39.1pdficonJiandeChaomeiDailyChemicalsCo.Ltd.F-Y3-AMedicalProtectiveMasksGB1908399.6897.752020-77.3pdficonJiandeChaomeiDailyChemicalsCo.Ltd.6005-1GB262699.1998.732020-110.1pdficonJiangmenHuayueIndustrialCo.,Ltd.HY9501FoldingMask–KN95GB262699.5598.482020-72.1pdficonJiangsuHomcanMedicalTechnologyCo.,Ltd.HC-NP95ASelf-PrimingFilterEN14951.8017.202020-66.2pdficonJiangsuJitonClothingCorporationJT-KN95ReusableandSterilizableNano-maskKN95EN14996.7491.612020-10.1pdficonJiangsuNewbornMedicalTechnologyCo.,Ltd.ProtectiveMaskKN95GB262697.0750.702020-113.2pdficonJinhuaJiadaifuMedicalSuppliesCo.,Ltd.KN95FaceMask(Non-Medical)GB262699.5754.902020-113.3pdficonJiningJiandaMedicalDeviceTechnologyCo.,Ltd.PM2.5KN95EN149,GB262664.8059.602020-21.3pdficonKindlyCareProductsCo.,Ltd.Y-9500GB262691.6489.802020-66.1pdficonKindlyCareProductsCo.,Ltd.Y-9500GB262690.7188.202020-79.1pdficonKingYearandPackagingCo.,Ltd.Self-BreathingFiltrationParticle-PreventiveRespiratorEN149,GB262690.0382.702020-62.2pdficonKingYearandPackagingCo.,Ltd.Self-BreathingFiltrationParticle-PreventiveRespiratorEN149,GB262691.1283.402020-62.1pdficonKuangye(Dongguan)TechnologyCo.,Ltd.GeyouKN95EnvironmentalProtectiveRespiratorGB262697.1013.602020-78.2pdficonLaianzhiKLT01GB262699.6897.832020-06.2pdficonLamdownSD-KN95GB262699.2289.602020-71.1pdficonLanshanShendunTechnologyCo.,Ltd.SD-KN95GB262698.1494.912020-80.1pdficonLanshanShendunTechnologyCo.,Ltd.SD-KN95GB262699.7166.802020-69.1pdficonLiaoningShengjingtangBiotechnologyCo.,Ltd.MedicalProtectiveMaskN95GB1908398.7496.712020-20.1pdficonLitezAllWanningProtectiveMaskGB262698.1443.002020-56.2pdficonNantongGold-SufangWeavingCo.Ltd.KN95FaceMaskGB262693.3984.202020-56.1pdficonNingboGreenHealthScience&TechnologyCo.,Ltd.KN95ProtectiveMaskGB262645.8033.202020-54.1pdficonNingboGreenHealthScience&TechnologyCo.,Ltd.DisposableProtectiveMask(Non-Medical)GB262623.9011.202020-117.1pdficonNingboYiXinIntelligentizedScienceandTechnologyCo.Ltd.KN95(Non-medical)GB262659.5053.202020-86.2pdficonPurvigorKN95AntibacterialMaskGB262674.2069.802020-33.1pdficonQingdaoHainuoBioengineeringCo.,Ltd.HynautKN95ProtectiveFaceMaskGB262698.3797.982020-96.1pdficonQingdaoMayshengMedicalDevicesCo.,LtdKN95ProtectiveMask(SelfSuctionFilterRespiratorFFP2)GB262699.5999.302020-45.1pdficonRizhaoSanqiMedical&HealthArticlesCo.,Ltd.3Q9505GB262699.3996.952020-29.1pdficonSanJiaoJS95-01EN14989.0082.402020-104.1pdficonScoticsScience&TechnologyCo.SKSSSterileN95GB1908397.3696.652020-22.1pdficonShandongTricolMarineBiologicalTechnologyCo.,Ltd.KN95ParticulateRespiratorforPPEwithHeadstrap+HookGB262699.5798.712020-115.1pdficonShanghaiDashengHealthProductsManufactureCo.,Ltd.DTC3BUSA(claimed,42CFR84)99.7699.672020-57.1pdficonShanghaiDashengHealthProductsManufactureCo.,Ltd.DTC3XUSA(claimed,42CFR84)99.9599.582020-57.2pdficonShanghaiDashengHealthProductsManufactureCo.,Ltd.DTC3B-1GB262699.9299.832020-77.1pdficonShanghaiDashengHealthProductsManufactureCo.,Ltd.DTC3X(SampleGroup1of3)USA(claimed,42CFR84)99.6698.322020-94.1pdficonShanghaiDashengHealthProductsManufactureCo.,Ltd.DTC3X(SampleGroup2of3)USA(claimed,42CFR84)99.6399.312020-94.2pdficonShanghaiDashengHealthProductsManufactureCo.,Ltd.DTC3X(SampleGroup3of3)USA(claimed,42CFR84)99.7699.342020-94.3pdficonShanghaiDashengHealthProductsManufactureCo.,Ltd.DTC3XUSA(claimed,42CFR84)99.8499.452020-119.2pdficonShanghaiGangkaiPurifyingProductsCo.,Ltd.8012GB262699.1398.112020-58.1pdficonShanghaiHuaxiangWoolenDressingCo.,Ltd.DisposableMaskGB262698.5197.482020-53.1pdficonSenkePharmaceutical(Chengdu)Co.,Ltd.KN95Non-PoweredAir-PurifyingParticulateRespiratorEN149,GB262698.3692.192020-78.9pdficonShenzhenHangsenStarTechnologyCo.,Ltd.AlchemyKN95FaceMaskA1EN149,GB262692.7756.002020-84.1pdficonShenzhenKawangNetworkTechnologyCo.,Ltd.FFP3EN14999.1798.772020-21.2pdficonShenzhenMeiliMedicalDevicesCo.,Ltd.KN95ProtectiveMaskEN149,GB262698.2958.402020-90.1pdficonSinpupHealth(Shenzhen)Co.,Ltd.FaceMaskKN95EN149,GB262674.3043.102020-90.2pdficonSuzhouJinruidaProtectiveEquipmentCo,Inc.KN95ThreeDimensionalRespiratorGB262699.3197.872020-34.1pdficonTeYinTY0929FFP2NREN14999.7098.892020-43.1pdficonTongchengChengfengProtectiveEquipmentCo.,Ltd.WanhuizhongAnti-DustRespiratorGB262659.2032.502020-98.1pdficonUNKNOWNUNKNOWNGB262699.6098.142020-29.2pdficonUNKNOWNKN95EarFaceMaskEN149,GB262693.6091.552020-42.1pdficonUNKNOWNKN95DailyProtectiveMaskGB262697.0884.802020-56.4pdficonUNKNOWNKN95ProtectiveMaskGB262668.9014.802020-67.2pdficonUNKNOWNKN95UNKNOWN90.5034.602020-70.1pdficonUNKNOWNHazeMaskKN95EN149,GB262681.2078.102020-82.1pdficonUNKNOWNPLOWKN95GB262691.0566.402020-15.1pdficonXiamenLixiaMedicalTechnologyCo.,Ltd.LixiaMedicalRespiratorGB262699.9699.312020-78.10pdficonXiamenLuan’anProtectiveEquipmentCo.,Ltd.EversafeKN95Self-PrimingFilterRespiratorGB262698.1697.562020-109.1pdficonZhandjiagangMeijieCommodityCo.,LtdMJ-N02A(ParticulateRespirator)GB262699.4798.552020-26.1pdficonZhangjiagangZhiyiMedicalMaterialsCo.Self-PrimingFilterRespiratorKN95GB1908399.2697.932020-13.1pdficonZhejiangAlltaIndustrialCo.,LTDALLTARespirator9591GB262698.0893.612020-32.1pdficonZhejiangKanghaoMedicalInstrumentsCo.,Ltd.KN95RespiratorGB262650.2028.302020-78.7pdficonZhejiangLvMeiBiotechCo.BeBettyParticulateRespiratorGB262698.7197.102020-56.5pdficonZhejiangXingxinMedicalTechologyCo.,Ltd.KN95ProtectiveFaceMasksGB262698.8190.932020-78.6pdficonZhongshanCassieyBiotechnologyCo.,Ltd.N95Masks+ParticulateProtectionRespiratorEN149,GB262649.5041.502020-92.1pdficon