美国公布新一批不合格口罩产品(合计99)


发布时间:2020-05-21 18:32 浏览量 1566 views
本文链接:www.zhaowoce.com/news/10185.html
摘要: 不久前FDA突然在EUA名单中取消了60多家中国制造商在美国销售KN95口罩的许可。5月21日,美国疾控中心(CDC)也发布了一批接受检测的口罩及生产商名单,未达到最低95%过滤标准的企业产品达99(总数171,合格率约42%)。

不久前FDA突然在EUA名单中取消了60多家中国制造商在美国销售KN95口罩的许可。5月21日,美国疾控中心(CDC)也发布了一批接受检测的口罩及生产商名单,未达到最低95%过滤标准的企业产品达99(总数171,合格率约42%)。

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美国CDC当地时间21日发布更新通知


来源 https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html



当地时间5月21日,美国疾控中心(CDC)也更新发布了一批接受检测的口罩及生产商名单,未达到最低95%过滤标准的企业产品达99。
同时美国疾控中心表示,NIOSH已获悉,中国许多合法制造商产品被伪造。在这种情况下,NIOSH无法验证哪些产品是假冒的,哪些是真实的。虽然表中列出的制造商显示为所评估产品的制造商,但NIOSH已获悉其中一些实际上是假冒产品。某些具有合法制造商名称的产品,其过滤器渗透效果不佳(<95%),是假冒产品。许多制造商还通知NIOSH,他们未生产与其名称相关的产品。表中标有星号(*)的制造商已告知NIOSH,所评估的产品不是由他们生产的,应被视为伪造和滥用其公司名称。
同时CDC表示,这些评估不属于NIOSH审批流程的一部分,也不会导致或阻止NIOSH通过正式审批流程获得批准。制造商、分销商、供应商和进口商不得利用这些结果对其产品进行索赔和/或影响购买者。


详情请见:

https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html


下表中背景为白色的表示“过滤率最小值不低于95%”为合格企业,背景为蓝色的表示“过滤率最小值低于95%”为不合格企业


International Assessment Results


Manufacturer

Model Number/Product Line

International

Filtration Efficiency (%)

Standard

Maximum

Minimum

1

3M

9502+

GB2626

98.56

98.24

2

Anhui Baishidun Protective Equipment Co., Ltd.

Baishidun FFP2

EN149, GB2626

53

46.1

3

Anhui Changli Environmental Protection Technology Co., Ltd

KN95 Protective Mask

EN149

95.74

94.73

4

Anhui Hongqiaosi Hometextile Co., Ltd.

KN95 Disposable Protective Face Mask

UNKNOWN

99.8

99.64

5

Anhui Jinling Plastics Co., Ltd.

UNKNOWN

GB2626

96.13

77.6

6

Anhui Jinling Plastics Company Limited

Protective Mask

EN149

99.66

98.67

7

Anhui Kangweijia Labor Protection Articles Co., Ltd.

9501 Protective Mask

EN149, GB2626

98.92

92.05

8

An Hui Su Bo Lun Clothing Co., Ltd.*

SU KN95

GB2626

95.1

28.45

9

Anshun Health & Medical Technology Co., Ltd.

AKF2002

GB2626

100

99.93

10

Baoji Taidakang Medical Technology Co., Ltd.

Medical Protective Mask

GB19083

99.27

94.3

11

Baoji Taidakang Medical Technology Co., Ltd.

Folding Mask with Ear Loop

GB19083

99.51

99.25

12

Baoji Taidakang Medical Technology Co., Ltd.

Butterfly Ear Hanging

GB19083

99.56

99.09

13

Beijing Ruishan Bozhong Medical Instrument Co., Ltd.*

RZ95B

EN149, GB2626

33.9

27

14

Changning Lingjiakang Protective Products Factory

KN95 Stereo Protective Mask

EN149

50.74

33.75

15

Changshu City Hengyun Nonwoven Products Co., Ltd.

KN95 Respirator Masks

GB2626

97.29

88.53

16

Chengde Technology Co., Ltd.

KN95 Respirator Protective Mask

EN149, GB2626

99.54

95.11

17

Chunyu

Chunyu FFP2

EN149

99.03

97.54

18

CTT Co., Ltd.

KN95 (8410)

EN149, GB2626

98.83

85.7

19

CSIC Pacli (Nanjng) Tech Co. Ltd.

Filtered Protective Mask KN95

GB2626

97.72

96.74

20

Daddybaby Co., Ltd.

KN95 4-PLY

EN149

93.45

91.15

21

Daddybaby Co., Ltd.

Protective Mask (Not for Medical Use)

GB2626

92.74

90.61

22

Delta Plus

CA 38.504

ABNT/NBR 13698

99.43

93.09

23

Dobu Life Tech Co., Ltd.

Dobu #201

KMOEL

99.94

99.85

24

Dongguan AOXING AV Equipment Co., Ltd.

AX-KF95 (KN95 Protective Mask)

EN149

99.57

99.02

25

Dongguan Arun Industrial Co., Ltd.

N9

EN149, GB2626

99.14

96.87

26

Dongguan HuaGang Communication Technology Co., Ltd.

KN95 Disposable Face Mask

EN149

98.73

25.6

27

Dongguan Mau Gee Industrial Ltd.

KN95 Disposable Face Mask

GB2626

97.24

88.43

28

Dongguan Oukangda Medical Technology Co., Ltd.

Self-Priming Filter Respirator

GB2626

93.76

20

29

Dongguan Oukangda Medical Technology Co., Ltd.

Kangerda KN95 Particulate Respirator

EN149, GB2626

93.68

90.28

30

Dongguan Xianda Medical Equipment Co., Ltd.

KN95 Protective Mask

EN149, GB2626

35

24.1

31

Dongguan Xianda Medical Equipment Co., Ltd.

KN95 Protective Mask

GB2626

99.63

99.47

32

Dongguan Xianda Medical Equipment Co., Ltd.

Tomson Newt KN95 Protective Mask

GB2626

66.3

39.5

33

Fengxian Ratone Medical Technology Co., Ltd.

CX-SJ-003 (KN95 Protective Mask)

GB2626

98.21

96.03

34

Foshan Flying Medical Products Co., Ltd.

KFT-02

GB19083

97.98

96.88

35

Foshan Nanhai Weijian Sanbang Protective Equipment Technology Co., Ltd.

9051A

EN149

97.7

97.38

36

Gaomi City Hancheng Personal Protective Products Co., Ltd.

Baokangjie 9001

GB2626

99.15

98.19

37

Garry Galaxy Biotechnology Co., Ltd.

Respirator Mask With TruTone Technology

GB/T 32610

44.3

35.2

38

Guangdong Energy Fortress Pharmaceutical Co., Ltd.

KN95 Protective Respirator

GB2626

100

95.36

39

Guangdong Fei Fan Mstar Technology LTD

Purvigor KN95

EN149, GB2626

68.83

61.6

40

Guangdong Medical Technology Co., Ltd.

KN95 Stereo Protective Mask

EN149

99.18

97.91

41

Guangdong Nafei Industrial Holding Co., Ltd.*

Efficient Nursing Protective Mask

EN149, GB2626

10.5

1.1

42

Guangdong Nafei Industrial Holding Co., Ltd.*

NAFY Protective Mask

EN149

20.4

13.9

43

Guangdong Nuokang Medical Technology Co., Ltd.

KN95-Certified Particulate Respirator

GB2626

98.73

24.22

44

Guangdong Nuokang Medical Technology Co., Ltd.

KN95 Non-Surgical Disposable

GB2626

99.6

98.05

45

Particulate FFR

46

Guangdong Qianjing Testing Co., Ltd.

DNW Protective Mask

EN149, GB2626

91.6

85.5

47

Guangdong Qian Jing Testing Co., LTD.

DNW Protective Mask

EN149, GB2626

76.5

69.2

48

Guangdong Shantou Machinery

KN95 Mask

EN149, GB2626

49

34.7

49

Guangdong Zhizhen Biological Medicine Co., Ltd.

KN95 Three-Dimensional

GB2626

89.8

88.7

50

Protective Respirator

51

Guangdong Zhizhen Biological Medicine Co., Ltd.

Industrial Protective Face Mask

EN149

96.66

61.2

52

Guangdong Zhizhen Biological Medicine Co., Ltd.

KN95 Three-Dimensional Protective Respirator

GB2626

80.6

23.1

53

Guangdong Zhizhen Biological Medicine Co., Ltd.

KN95 Three-Dimensional Protective Respirator

GB2626

96.5

88.6

54

Guangdong Zhizhen Biological Medicine Co., Ltd.

KN95 Three-Dimensional Protective Respirator

GB2626

41.7

12

55

Guangdong Zhizhen Biological Medicine Co., Ltd.

KN95 Three-Dimensional Protective Respirator

EN149

80.9

14.6

56

Guangzhou Aiyinmei Co., Ltd.

AYM-KN95

GB2626

68.8

38.9

57

Guangzhou Aiyinmei Co., Ltd.

A&F KN95

EN149, GB2626

98.1

32.3

58

Guangzhou Aiyinmei Co., Ltd.

KN95 Protective Mask (Non-Medical)

GB2626

98.27

89.9

59

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

KN95 Protective Mask

GB2626

99.4

99.21

60

Guangzhou Harley Commodity Co., Ltd.

L-103V KN95

GB2626

99.49

99.02

61

Guangzhou Huashan Biotechnology Co., Ltd.

GF-Mask KN95 Mask

GB2626

74.9

27.1

62

Guangzhou Kangbang Medical Equipment Co., Ltd.*

KN95 Mask

EN149

98.86

72

63

Guangzhou Nan Qi Xing Nonwoven Co., Ltd.

KN95 Mask

GB2626

96.99

95.67

64

Guangzhou Powecom Labor Insurance Supplies Co., Ltd.

Powecom KN95 Protective Mask

GB2626

98.21

97.04

65

Guangzhou Powecom Labor Insurance Supplies Co., Ltd.

Powecom KN95 Protective Mask

GB2626

98.91

98.6

66

Guangzhou Powecom Labor Insurance Supplies Co., Ltd.

Powecom KN95 Protective Mask

GB2626

94.87

93.19

67

Guangzhou Sunjoy Auto Supplies Co., Ltd.*

K1 Self Suction Filter Respirator

GB2626

43.7

12.3

68

Guangzhou Sunjoy Auto Supplies Co., Ltd.

SUNJOY K1

GB2626

34.2

24.3

69

Guangzhou Tianyi Zhongliang Biotechnology Group Co., Ltd.

KN95 Disposable Protective Mask

GB2626

97.29

87.2

70

Guanyang Yuhan Textile Co., Ltd.

KN95 Protective Face Mask

GB2626

56.59

42.15

71

Hangzhou Senrunqing Technology Co., Ltd.

KN95 Mask-C

EN149, GB2626

85.9

78.7

72

Henan Fengzihihuang Industrial Co., Ltd.

HF/KN95-2

GB2626

57.9

49.1

73

Henan Kang Medical Devices Co., Ltd.

KN95 Protective Mask – KS16

GB2626

97.5

52.1

74

Honeywell Safety Products (Shanghai) Co., Ltd.

H801 Particulate Respirator

GB2626

99.32

98.4

75

Huabai

9501

GB2626

97.07

69

76

Huizhou Huinuo Technology Co., Ltd.

HV-N 9501B (Non-Sterile Mask)

GB2626

96.55

88.81

77

Huizhou Huinuo Technology Co., Ltd.

HV-N White KN95

GB2626

94.98

90.58

78

Huizhou Zhongna Medical Technology Co., Ltd

Anysound KN95 Self-Priming Filter & Anti-Particle Respirator

EN149, GB2626

83.41

77.3

79

Jiande Chaomei Daily Chemicals Co., Ltd.

CM 9527

GB19083

99.29

97.87

80

Jiande Chaomei Daily Chemicals Co. Ltd.

F-Y3-A Medical Protective Masks

GB19083

99.68

97.75

81

Jiande Chaomei Daily Chemicals Co. Ltd.

Jan-05

GB2626

99.19

98.73

82

Jiangmen Huayue Industrial Co., Ltd.

HY9501 Folding Mask – KN95

GB2626

99.55

98.48

83

Jiangsu Jiton Clothing Corporation

JT-KN95 Reusable and Sterilizable Nano-mask KN95

EN149

96.74

91.61

84

Jiangsu Newborn Medical Technology Co., Ltd.

Protective Mask KN95

GB2626

97.07

50.7

85

Jiangsu Weibang Medical Products Co., Ltd.

KN95 Diposable Particulate Respirator

GB2626

99.65

97.89

86

Jinhua Jiadaifu Medical Supplies Co., Ltd.

KN95 Face Mask (Non-Medical)

GB2626

99.57

54.9

87

Jining Jianda Medical Device Technology Co., Ltd.

PM2.5 KN95

EN149, GB2626

64.8

59.6

88

Kindly Care Products Co., Ltd.

Y-9500

GB2626

91.64

89.8

89

Kindly Care Products Co., Ltd.

Y-9500

GB2626

90.71

88.2

90

King Year and Packaging Co., Ltd.

Self-Breathing Filtration Particle-Preventive Respirator

EN149, GB2626

90.03

82.7

91

King Year and Packaging Co., Ltd.

Self-Breathing Filtration Particle-Preventive Respirator

EN149, GB2626

91.12

83.4

92

Kuangye (Dongguan) Technology Co., Ltd.

Geyou KN95 Environmental Protective Respirator

GB2626

97.1

13.6

93

Laianzhi

KLT01

GB2626

99.68

97.83

94

Lamdown

SD-KN95

GB2626

99.22

89.6

95

Lanshan Shendun Technology Co., Ltd.

SD-KN95

GB2626

98.14

94.91

96

Lanshan Shendun Technology Co., Ltd.

SD-KN95

GB2626

99.71

66.8

97

Liaoning Shengjingtang Biotechnology Co., Ltd.

Medical Protective Mask N95

GB19083

98.74

96.71

98

LitezAll

Wanning Protective Mask

GB2626

98.14

43

99

Magnum Health & Safety Pvt. Ltd.

Dustoguard Exhale

EN149

91.62

88.7

100

Nantong Gold-Sufang Weaving Co. Ltd.

KN95 Face Mask

GB2626

93.39

84.2

101

Neolithic Tech Co., Ltd.

N95 Medical Protective Mask

EN149

99.99

99.81

102

Ningbo Green Health Science & Technology Co., Ltd.

KN95 Protective Mask

GB2626

45.8

33.2

103

Ningbo Green Health Science & Technology Co., Ltd.

Disposable Protective Mask (Non-Medical)

GB2626

23.9

11.2

104

Ningbo YiXin Intelligentized Science and Technology Co. Ltd.

KN95 (Non-medical)

GB2626

59.5

53.2

105

Purvigor

KN95 Antibacterial Mask

GB2626

74.2

69.8

106

Putian City Puxin Medical Technology Co.

Disposable Mask for Civil Use

GB2626

72.1

35.6

107

Qingdao Hainuo Bioengineering Co., Ltd.

Hynaut KN95 Protective Face Mask

GB2626

98.37

97.98

108

Qingdao Maysheng Medical Devices Co., Ltd

KN95 Protective Mask

GB2626

99.59

99.3

109

(Self Suction Filter Respirator FFP2)

110

Raxwell Industrial Technology (Shanghai) Co., Ltd.

RX9501

GB2626

99.69

99.48

111

Rizhao Sanqi Medical & Health Articles Co., Ltd.

3Q 9505

GB2626

99.39

96.95

112

San Jiao

JS95-01

EN149

89

82.4

113

Sanjiao Oral Health Co., Ltd.

KN95 Daily Protective Face Mask

UNKNOWN

98.5

89.1

114

Scotics Science & Technology Co.

SKSS Sterile N95

GB19083

97.36

96.65

115

Shandong Minghang Nonwoven Products Co., Ltd.

Dr. Dust 3-Dimensional Protective Mask

EN149

99.99

99.81

116

Shandong Sino Medical Equipment Co., Ltd.

D918

GB19083

98.35

97.15

117

Shandong Tricol Marine Biological Technology Co., Ltd.

KN95 Particulate Respirator for PPE

GB2626

99.57

98.71

118

with Headstrap + Hook

119

Shanghai Dasheng Health Products Manufacture Co., Ltd.

DTC3B

USA (claimed, 42 CFR 84)

99.76

99.67

120

Shanghai Dasheng Health Products Manufacture Co., Ltd.

DTC3X

USA (claimed, 42 CFR 84)

99.95

99.58

121

Shanghai Dasheng Health Products Manufacture Co., Ltd.

DTC3B-1

GB2626

99.92

99.83

122

Shanghai Dasheng Health Products Manufacture Co., Ltd.

DTC3X (Sample Group 1 of 3)

USA (claimed, 42 CFR 84)

99.66

98.32

123

Shanghai Dasheng Health Products Manufacture Co., Ltd.

DTC3X (Sample Group 2 of 3)

USA (claimed, 42 CFR 84)

99.63

99.31

124

Shanghai Dasheng Health Products Manufacture Co., Ltd.

DTC3X (Sample Group 3 of 3)

USA (claimed, 42 CFR 84)

99.76

99.34

125

Shanghai Dasheng Health Products Manufacture Co., Ltd.

DTC3X

USA (claimed, 42 CFR 84)

99.84

99.45

126

Shanghai Dasheng Health Products Manufacture Co., Ltd.*

DTC3X

USA (claimed, 42 CFR 84)

98.34

90.45

127

Shanghai Dasheng Health Products Manufacture Co., Ltd.

DTC3X

USA (claimed, 42 CFR 84)

99.75

99.44

128

Shanghai Dasheng Health Products Manufacture Co., Ltd.*

DTC3X

USA (claimed, 42 CFR 84)

97.03

87.2

129

Shanghai Dasheng Health Products Manufacture Co., Ltd.

DTC3X

USA (claimed, 42 CFR 84)

99.66

99.24

130

Shanghai Gangkai Purifying Products Co., Ltd.

8012

GB2626

99.13

98.11

131

Shanghai Huaxiang Woolen Dressing Co., Ltd.

Disposable Mask

GB2626

98.51

97.48

132

Senke Pharmaceutical (Chengdu) Co., Ltd.

KN95 Non-Powered Air-Purifying Particulate Respirator

EN149, GB2626

98.36

92.19

133

Shenzhen Hangsen Star Technology Co., Ltd.

Alchemy KN95 Face Mask A1

EN149, GB2626

92.77

56

134

Shenzhen Jiameilantai Industrial Co., Ltd.

Face Mask

EN149, GB2626

92.11

42

135

Shenzhen Kawang Network Technology Co., Ltd.

FFP3

EN149

99.17

98.77

136

Shenzhen Meili Medical Devices Co., Ltd.

KN95 Protective Mask

EN149, GB2626

98.29

58.4

137

Shenzhen Sanai Medical Devices Group Co., Ltd.

Disposable Protective Mask

GB2626

90.04

86

138

Shenzhen Zhongyue Health Technology Co., Ltd.

KN95 Protective Mask

EN149

96.07

95.03

139

Sinpup Health (Shenzhen) Co., Ltd.

Face Mask KN95

EN149, GB2626

74.3

43.1

140

Suzhou Jinruida Protective Equipment Co, Inc.

KN95 Three Dimensional Respirator

GB2626

99.31

97.87

141

Te Yin

TY0929 FFP2 NR

EN149

99.7

98.89

142

Tianjin Benmo Medical Equipment Co., Ltd.

ONO KN95 Folding Protective Mask

GB2626

84.5

32.7

143

Tongcheng Chengfeng Protective Equipment Co., Ltd.

Wanhuizhong Anti-Dust Respirator

GB2626

59.2

32.5

144

Trust Loyalty & Glory Epoch Network Technology Co., Ltd.

Respiratory Face Mask

GB2626

99.23

98.29

145

UNKNOWN

UNKNOWN

GB2626

99.6

98.14

146

UNKNOWN

KN95 Ear Face Mask

EN149, GB2626

93.6

91.55

147

UNKNOWN

KN95 Daily Protective Mask

GB2626

97.08

84.8

148

UNKNOWN

KN95 Protective Mask

GB2626

68.9

14.8

149

UNKNOWN

KN95

UNKNOWN

90.5

34.6

150

UNKNOWN

Haze Mask KN95

EN149, GB2626

81.2

78.1

151

UNKNOWN

PLOW KN95

GB2626

91.05

66.4

152

UNKNOWN

Kangsiluo Disposable KN95

GB2626

51.8

17.2

153

UNKNOWN

UNKNOWN

EN149

92.58

90.18

154

UNKNOWN

UNKNOWN

GB2626

99.97

98.79

155

UNKNOWN

UNKNOWN

EN149

99.66

98.87

156

UNKNOWN

UNKNOWN

UNKNOWN

75.3

30.5

157

Weini Technology Development Co., Ltd.

WN 958 Particulate Respirator

GB2626

99.62

97.62

158

Xiamen Lixia Medical Technology Co., Ltd.

Lixia Medical Respirator

GB2626

99.96

99.31

159

Xiamen Luan’an Protective Equipment Co., Ltd.

Eversafe KN95 Self-Priming Filter Respirator

GB2626

98.16

97.56

160

Yiwu Baibian Electronic Techology Co., Ltd.

Disposable Face Mask

GB2626

99.46

98.94

161

Yiwu Qixun Scientific Co., Ltd.

Qixun KN95 Mask

GB2626

98.63

31.4

162

Zhangjiagang Meijie Commodity Co., Ltd

MJ-N02A (Particulate Respirator)

GB2626

99.47

98.55

163

Zhangjiagang Zhiyi Medical Materials Co.

Self-Priming Filter Respirator KN95

GB19083

99.26

97.93

164

Zhangzhou Easepal Industrial Co., Ltd.

BRI-2100

GB2626

99.6

99.13

165

Zhejiang Allta Industrial Co., LTD

ALLTA Respirator 9591

GB2626

98.08

93.61

166

Zhejiang Kanghao Medical Instruments Co., Ltd.

KN95 Respirator

GB2626

50.2

28.3

167

Zhejiang Lv Mei Biotech Co.

BeBetty Particulate Respirator

GB2626

98.71

97.1

168

Zhejiang Xingxin Medical Techology Co., Ltd.

KN95 Protective Face Masks

GB2626

98.81

90.93

169

Zhejiang Yinghua Technology Co., Ltd.

Gitemk FFP2 Protective Mask

EN149, GB2626

99.97

99.84

170

Zhongshan Cassiey Biotechnology Co., Ltd.

N95 Masks + Particulate Protection Respirator

EN149, GB2626

49.5

41.5

171

Zhongshan Zhongxin Medical Technology Co., Ltd.*

Protective Mask

EN149

72.4

52.3

详情请见:

https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html



 加拿大召回60家不合格企业产品 


5月16日,加拿大发出官方公告,在对部分进口口罩等防疫物资的质量和安全性发出警告的同时,还召回60家不合格企业产品

微信图片_20200521185818.jpg


加拿大官方当地时间16日发布更新通知

加拿大卫生部已经确定,部分KN95过滤式口罩的过滤率无法达到95%要求,可能会被进口到加拿大,对使用者构成健康和安全风险。随着加拿大卫生部获得与此次召回有关的新信息,官方要求制造商、进口商和分销商根据《医疗器械法规》第64条规定自行召回产品。

以下是加拿大官方公布的60家不合格名单

微信图片_20200521185823.jpg

我国已针对医疗物资出口接连发布5号、12号公告,以及公布黑白名单,违法违规出口不合格口罩等物资企业通告等,希望以此加强口罩等物资的出口管控,保障市场流通产品的质量。虽然国家对医疗物资制售、出口等市场管理愈加严格,但是依然有很多企业顶风作案,违法违规制售、出口。
对此,海关多次提醒,在出口相关防疫物资时必须严格履行如实申报责任。对违法、失信企业,海关将加大曝光力度,通过提高查验比例、加大稽核查频次、开展多部门信用联合惩戒等更加严格的监管措施,让违法失信者寸步难行。
对出口经检验不合格商品,或出口属于掺杂掺假、以假充真、以次充好的商品,以及以不合格商品冒充合格商品的,将依法依规采取责令停止出口、没收违法所得、没收出口商品、罚款等处罚措施,对构成犯罪的,依法追究刑事责任。
尽管如此,很多企业还是没有禁受得住金钱的诱惑,顶风作案!希望大家引以为戒!



关键词 : 不合格口罩 口罩
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