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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

蓝冠信息网 2020/05/09 10:34:11 点击 1633 次
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[导读] 5月7日,美国食品和药物监督管理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。

蓝冠信息网讯 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。

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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:

CTT Co. Ltd

Daddybaby Co. Ltd

Dongguan Xianda Medical Equipment Co., Ltd.

Guangdong Fei Fan Mstar Technology LTD

Guangdong Nuokang Medical Technology Co., Ltd.

Huizhou Huinuo Technology Co., Ltd.

Lanshan Shendun Technology Co

NIOSH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)

Manufacturer

Model   Number/Product Line

International
  Standard

Filtration   Efficiency (%)

Test   Report

Maximum

Minimum

Anhui Baishidun   Protective Equipment Co., Ltd.

Baishidun FFP2

EN149, GB2626

53.00

46.10

Anhui Changli   Environmental Protection Technology Co., Ltd

KN95 Protective   Mask

EN149

95.74

94.73

Anhui Hongqiaosi   Hometextile Co., Ltd.

KN95 Disposable   Protective Face Mask

UNKNOWN

99.80

99.64

Anhui Jinling   Plastics Co., Ltd.

UNKNOWN

GB2626

96.13

77.60

Anhui Jinling   Plastics Company Limited

Protective Mask

EN149

99.66

98.67

Anhui Kangweijia   Labor Protection Articles Co., Ltd.

9501 Protective   Mask

EN149, GB2626

98.92

92.05

Anhui RYZUR   Medical Equipment Manufacturing Co., Ltd.

KN95B

EN149, GB2626

33.90

27.00

An Hui Su Bo Lun   Clothing Co., Ltd.

SU KN95

GB2626

95.10

28.45

Baoji Taidakang   Medical Technology Co., Ltd

Medical   Protective Mask

GB19083

99.27

94.30

Changning   Lingjiakang Protective Products Factory

KN95 Stereo   Protective Mask

EN149

50.74

33.75

Changshu City   Hengyun Nonwoven Products Co., Ltd.

KN95 Respirator   Masks

GB2626

97.29

88.53

Chunyu

Chunyu FFP2

EN149

99.03

97.54

CTT Co., Ltd.

KN95 (8410)

EN149, GB2626

98.83

85.70

CSIC Pacli   (Nanjng) Tech Co. Ltd.

Filtered   Protective Mask KN95

GB2626

97.72

96.74

Daddybaby Co.,   Ltd.

KN95 4-PLY

EN149

93.45

91.15

Delta Plus

CA 38.504

ABNT/NBR 13698

99.43

93.09

Dobu Life Tech   Co., Ltd.

Dobu #201

KMOEL

99.94

99.85

Dongguan   Oukangda Medical Technology Co., Ltd.

Self-Priming   Filter Respirator

GB2626

93.76

20.00

Dongguan   Oukangda Medical Technology Co., Ltd.

Kangerda KN95   Particulate Respirator

EN149, GB2626

93.68

90.28

Dongguan Xianda   Medical Equipment Co., Ltd.

KN95 Protective   Mask

EN149, GB2626

35.00

24.10

Dongguan Xianda   Medical Equipment Co., Ltd.

KN95 Protective   Mask

GB2626

99.63

99.47

Flyhorse   Industrial Co., Ltd.

FL 0616

EN149

92.58

90.18

Gaomi City   Hancheng Personal Protective Products Co., Ltd.

Baokangjie 9001

GB2626

99.15

98.19

Garry Galaxy   Biotechnology Co., Ltd.

Respirator Mask   With TruTone Technology

GB/T 32610

44.30

35.20

Guangdong Energy   Fortress Pharmaceutical Co., Ltd.

KN95 Protective   Respirator

GB2626

100.00

95.36

Guangdong Fei   Fan Mstar Technology LTD

Purvigor KN95

EN149, GB2626

68.83

61.60

Guangdong   Medical Technology Co., Ltd.

KN95 Stereo   Protective Mask

EN149

99.18

97.91

Guangdong Nafei   Industrial Holding Co., Ltd.

Efficient   Nursing Protective Mask

EN149, GB2626

10.50

1.10

Guangdong Nafei   Industrial Holding Co., Ltd.

NAFY Protective   Mask

EN149

20.40

13.90

Guangdong   Nuokang Medical Technology Co., Ltd.

KN95-Certified   Particulate Respirator

GB2626

98.73

24.22

Guangdong Qian   Jing Testing Co., LTD.

DNW Protective   Mask

EN149, GB2626

76.50

69.20

Guangdong   Shantou Machinery

KN95 Mask

EN149, GB2626

49.00

34.70

Guangdong   Zhizhen Biological Medicine Co., Ltd.

KN95   Three-Dimensional
  Protective Respirator

GB2626

89.80

88.70

Guangzhou   Baoweikang (Powecom) Personal Protection Equipment Co., Ltd.

KN95 Protective   Mask

GB2626

99.40

99.21

Guangzhou Harley   Commodity Co., Ltd.

L-103V KN95

GB2626

99.49

99.02

Guangzhou   Huashan Biotechnology Co., Ltd.

GF-Mask KN95   Mask

GB2626

74.90

27.10

Guangzhou   Kangbang Medical Equipment Co., Ltd.

KN95 Mask

EN149

98.86

72.00

Guangzhou Sunjoy   Auto Supplies Co., Ltd.

K1 Self Suction   Filter Respirator

GB2626

43.70

12.30

Guangzhou Tianyi   Zhongliang Biotechnology Group Co., Ltd.

KN95 Disposable   Protective Mask

GB2626

97.29

87.20

Guanyang Yuhan   Textile Co., Ltd.

KN95 Protective   Face Mask

GB2626

56.59

42.15

Hangzhou   Senrunqing Technology Co., Ltd.

KN95 Mask-C

EN149, GB2626

85.90

78.70

Henan Kang   Medical Devices Co., Ltd.

KN95 Protective   Mask – KS16

GB2626

97.50

52.10

Honeywell Safety   Products (Shanghai) Co., Ltd.

H801 Particulate   Respirator

GB2626

99.32

98.40

Huabai

9501

GB2626

97.07

69.00

Huizhou Huinuo   Technology Co., Ltd.

HV-N 9501B   (Non-Sterile Mask)

GB2626

96.55

88.81

Huizhou Huinuo   Technology Co., Ltd.

HV-N White KN95

GB2626

94.98

90.58

Huizhou Zhongna   Medical Technology Co., Ltd

Anysound KN95   Self-Priming Filter & Anti-Particle Respirator

EN149, GB2626

83.41

77.30

Jiande Chaomei   Daily Chemicals Co., Ltd.

CM 9527

GB19083

99.29

97.87

Jiande Chaomei   Daily Chemicals Co. Ltd.

F-Y3-A Medical   Protective Masks

GB19083

99.68

97.75

Jiande Chaomei   Daily Chemicals Co. Ltd.

6005-1

GB2626

99.19

98.73

Jiangmen Huayue   Industrial Co., Ltd.

HY9501 Folding   Mask – KN95

GB2626

99.55

98.48

Jiangsu Homcan   Medical Technology Co., Ltd.

HC-NP95A   Self-Priming Filter

EN149

51.80

17.20

Jiangsu Jiton   Clothing Corporation

JT-KN95 Reusable   and Sterilizable Nano-mask KN95

EN149

96.74

91.61

Jiangsu Newborn   Medical Technology Co., Ltd.

Protective Mask   KN95

GB2626

97.07

50.70

Jinhua Jiadaifu   Medical Supplies Co., Ltd.

KN95 Face Mask   (Non-Medical)

GB2626

99.57

54.90

Jining Jianda   Medical Device Technology Co., Ltd.

PM2.5 KN95

EN149, GB2626

64.80

59.60

Kindly Care   Products Co., Ltd.

Y-9500

GB2626

91.64

89.80

Kindly Care   Products Co., Ltd.

Y-9500

GB2626

90.71

88.20

King Year and   Packaging Co., Ltd.

Self-Breathing   Filtration Particle-Preventive Respirator

EN149, GB2626

90.03

82.70

King Year and   Packaging Co., Ltd.

Self-Breathing   Filtration Particle-Preventive Respirator

EN149, GB2626

91.12

83.40

Kuangye   (Dongguan) Technology Co., Ltd.

Geyou KN95   Environmental Protective Respirator

GB2626

97.10

13.60

Laianzhi

KLT01

GB2626

99.68

97.83

Lamdown

SD-KN95

GB2626

99.22

89.60

Lanshan Shendun   Technology Co., Ltd.

SD-KN95

GB2626

98.14

94.91

Lanshan Shendun   Technology Co., Ltd.

SD-KN95

GB2626

99.71

66.80

Liaoning Shengjingtang   Biotechnology Co., Ltd.

Medical   Protective Mask N95

GB19083

98.74

96.71

LitezAll

Wanning   Protective Mask

GB2626

98.14

43.00

Nantong   Gold-Sufang Weaving Co. Ltd.

KN95 Face Mask

GB2626

93.39

84.20

Ningbo Green   Health Science & Technology Co., Ltd.

KN95 Protective   Mask

GB2626

45.80

33.20

Ningbo Green   Health Science & Technology Co., Ltd.

Disposable   Protective Mask (Non-Medical)

GB2626

23.90

11.20

Ningbo YiXin   Intelligentized Science and Technology Co. Ltd.

KN95   (Non-medical)

GB2626

59.50

53.20

Purvigor

KN95   Antibacterial Mask

GB2626

74.20

69.80

Qingdao Hainuo   Bioengineering Co., Ltd.

Hynaut KN95   Protective Face Mask

GB2626

98.37

97.98

Qingdao Maysheng   Medical Devices Co., Ltd

KN95 Protective   Mask
  (Self Suction Filter Respirator FFP2)

GB2626

99.59

99.30

Rizhao Sanqi   Medical & Health Articles Co., Ltd.

3Q 9505

GB2626

99.39

96.95

San Jiao

JS95-01

EN149

89.00

82.40

Scotics Science   & Technology Co.

SKSS Sterile N95

GB19083

97.36

96.65

Shandong Tricol   Marine Biological Technology Co., Ltd.

KN95 Particulate   Respirator for PPE
  with Headstrap + Hook

GB2626

99.57

98.71

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3B

USA (claimed, 42   CFR 84)

99.76

99.67

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3X

USA (claimed, 42   CFR 84)

99.95

99.58

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3B-1

GB2626

99.92

99.83

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3X (Sample   Group 1 of 3)

USA (claimed, 42   CFR 84)

99.66

98.32

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3X (Sample   Group 2 of 3)

USA (claimed, 42   CFR 84)

99.63

99.31

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3X (Sample   Group 3 of 3)

USA (claimed, 42   CFR 84)

99.76

99.34

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3X

USA (claimed, 42   CFR 84)

99.84

99.45

Shanghai Gangkai   Purifying Products Co., Ltd.

8012

GB2626

99.13

98.11

Shanghai   Huaxiang Woolen Dressing Co., Ltd.

Disposable Mask

GB2626

98.51

97.48

Senke   Pharmaceutical (Chengdu) Co., Ltd.

KN95 Non-Powered   Air-Purifying Particulate Respirator

EN149, GB2626

98.36

92.19

Shenzhen Hangsen   Star Technology Co., Ltd.

Alchemy KN95   Face Mask A1

EN149, GB2626

92.77

56.00

Shenzhen Kawang   Network Technology Co., Ltd.

FFP3

EN149

99.17

98.77

Shenzhen Meili   Medical Devices Co., Ltd.

KN95 Protective   Mask

EN149, GB2626

98.29

58.40

Sinpup Health   (Shenzhen) Co., Ltd.

Face Mask KN95

EN149, GB2626

74.30

43.10

Suzhou Jinruida   Protective Equipment Co, Inc.

KN95 Three   Dimensional Respirator

GB2626

99.31

97.87

Te Yin

TY0929 FFP2 NR

EN149

99.70

98.89

Tongcheng   Chengfeng Protective Equipment Co., Ltd.

Wanhuizhong   Anti-Dust Respirator

GB2626

59.20

32.50

UNKNOWN

UNKNOWN

GB2626

99.60

98.14

UNKNOWN

KN95 Ear Face   Mask

EN149, GB2626

93.60

91.55

UNKNOWN

KN95 Daily   Protective Mask

GB2626

97.08

84.80

UNKNOWN

KN95 Protective   Mask

GB2626

68.90

14.80

UNKNOWN

KN95

UNKNOWN

90.50

34.60

UNKNOWN

Haze Mask KN95

EN149, GB2626

81.20

78.10

UNKNOWN

PLOW KN95

GB2626

91.05

66.40

Xiamen Lixia   Medical Technology Co., Ltd.

Lixia Medical   Respirator

GB2626

99.96

99.31

Xiamen Luan’an   Protective Equipment Co., Ltd.

Eversafe KN95   Self-Priming Filter Respirator

GB2626

98.16

97.56

Zhandjiagang   Meijie Commodity Co., Ltd

MJ-N02A   (Particulate Respirator)

GB2626

99.47

98.55

Zhangjiagang   Zhiyi Medical Materials Co.

Self-Priming   Filter Respirator KN95

GB19083

99.26

97.93

Zhejiang Allta   Industrial Co., LTD

ALLTA Respirator   9591

GB2626

98.08

93.61

Zhejiang Kanghao   Medical Instruments Co., Ltd.

KN95 Respirator

GB2626

50.20

28.30

Zhejiang Lv Mei   Biotech Co.

BeBetty   Particulate Respirator

GB2626

98.71

97.10

Zhejiang Xingxin   Medical Techology Co., Ltd.

KN95 Protective   Face Masks

GB2626

98.81

90.93

Zhongshan   Cassiey Biotechnology Co., Ltd.

N95 Masks +   Particulate Protection Respirator

EN149, GB2626

49.50

41.50


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