91儀器信息網(wǎng)訊 當(dāng)?shù)貢r間5月7日，美國食品和藥物監(jiān)督管理局（FDA，下稱“美食藥監(jiān)局”）在官網(wǎng)向全體醫(yī)護(hù)人員致信稱，因一部分來自中國的口罩無法在新冠肺炎疫情期間起到足夠的保護(hù)作用，他們已取消了一些中國制造商在美國銷售N95口罩的許可。

美食藥監(jiān)局表示，他們發(fā)現(xiàn)有60多家中國制造商的口罩質(zhì)量不合格，因此將準(zhǔn)許在美銷售的中國口罩制造商數(shù)量由80家減少到14家。

由于新冠肺炎疫情大流行的原因，個人防護(hù)用品的需求激增，N95口罩因為可以過濾至少95%的空氣顆粒物，在疫情期間被美國疾病預(yù)防與控制中心（CDC，下稱美疾控中心）列為重要的防護(hù)用品。

美疾控中心下屬的美國國家職業(yè)安全衛(wèi)生研究所（NIOSH）最近在對67種不同類型的進(jìn)口N95口罩進(jìn)行檢測后發(fā)現(xiàn)，有約六成產(chǎn)品的過濾效果未達(dá)到美國N95口罩標(biāo)準(zhǔn)。

同時，NIOSH的測試還發(fā)現(xiàn)，7日被取消出口許可的一家中國公司的口罩只能過濾掉24%-35%的顆粒物，遠(yuǎn)低于N95口罩命名所要求的過濾95%顆粒物的標(biāo)準(zhǔn)，而這款口罩的包裝上宣稱過濾級別為五星級，并使用了未經(jīng)授權(quán)的FDA標(biāo)志。

正因為上述情況，美食藥監(jiān)局決定取消多家中國制造商在美銷售N95口罩的許可。這也意味著美食藥監(jiān)局推翻了4月3日所作出的一項決定（當(dāng)時，他們允許一些未經(jīng)美國政府檢測的制造商出口口罩到美國，只要通過一家獨立實驗室的審查即可）。

在迄今為止已從準(zhǔn)許名單中刪除的產(chǎn)品中，下列產(chǎn)品未能在NIOSH進(jìn)行的測試中顯示出至少95％的最小顆粒過濾效率：

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會定期更新其測試結(jié)果列表（文末附截至5月8日測試結(jié)果表）。

在德國從事口罩進(jìn)出口貿(mào)易的業(yè)內(nèi)人士曾指出，新冠疫情爆發(fā)前，國際上沒有對口罩質(zhì)量標(biāo)準(zhǔn)的統(tǒng)一規(guī)定，也缺乏權(quán)威的質(zhì)量認(rèn)證機制，這才是最大問題所在。

中國外交部發(fā)言人耿爽日前在記者會上表示，中方高度重視出口防疫醫(yī)療物資質(zhì)量問題，近期商務(wù)部會同海關(guān)總署、藥監(jiān)局、市場監(jiān)管總局已就有序開展醫(yī)療物資出口、加強質(zhì)量監(jiān)管出臺了多項舉措。防疫物資出口中出現(xiàn)的質(zhì)量問題，很多是因為中外質(zhì)量標(biāo)準(zhǔn)不同，使用習(xí)慣存在差異，外方未嚴(yán)格按照產(chǎn)品用途使用造成的。 耿爽表示，中方將會繼續(xù)嚴(yán)格執(zhí)行監(jiān)管政策，確保防疫物資出口質(zhì)量，同時也希望外方加強采購商在進(jìn)口環(huán)節(jié)的質(zhì)量檢測，并嚴(yán)格按照產(chǎn)品的適用范圍和操作規(guī)程正確使用。

附：NIOSH測試結(jié)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

2020-51.1pdf icon

Anhui Changli   Environmental Protection Technology Co., Ltd

KN95 Protective   Mask

EN149

95.74

94.73

2020-50.1pdf icon

Anhui Hongqiaosi   Hometextile Co., Ltd.

KN95 Disposable   Protective Face Mask

UNKNOWN

99.80

99.64

2020-80.2pdf icon

Anhui Jinling   Plastics Co., Ltd.

UNKNOWN

GB2626

96.13

77.60

2020-21.1pdf icon

Anhui Jinling   Plastics Company Limited

Protective Mask

EN149

99.66

98.67

2020-59.1pdf icon

Anhui Kangweijia   Labor Protection Articles Co., Ltd.

9501 Protective   Mask

EN149, GB2626

98.92

92.05

2020-86.1pdf icon

Anhui RYZUR   Medical Equipment Manufacturing Co., Ltd.

KN95B

EN149, GB2626

33.90

27.00

2020-66.3pdf icon

An Hui Su Bo Lun   Clothing Co., Ltd.

SU KN95

GB2626

95.10

28.45

2020-55.1pdf icon

Baoji Taidakang   Medical Technology Co., Ltd

Medical   Protective Mask

GB19083

99.27

94.30

2020-47.1pdf icon

Changning   Lingjiakang Protective Products Factory

KN95 Stereo   Protective Mask

EN149

50.74

33.75

2020-10.3pdf icon

Changshu City   Hengyun Nonwoven Products Co., Ltd.

KN95 Respirator   Masks

GB2626

97.29

88.53

2020-78.3pdf icon

Chunyu

Chunyu FFP2

EN149

99.03

97.54

2020-06.1pdf icon

CTT Co., Ltd.

KN95 (8410)

EN149, GB2626

98.83

85.70

2020-87.1pdf icon

CSIC Pacli   (Nanjng) Tech Co. Ltd.

Filtered   Protective Mask KN95

GB2626

97.72

96.74

2020-28.1pdf icon

Daddybaby Co.,   Ltd.

KN95 4-PLY

EN149

93.45

91.15

2020-29.4pdf icon

Delta Plus

CA 38.504

ABNT/NBR 13698

99.43

93.09

2020-45.2pdf icon

Dobu Life Tech   Co., Ltd.

Dobu #201

KMOEL

99.94

99.85

2020-115.2pdf icon

Dongguan   Oukangda Medical Technology Co., Ltd.

Self-Priming   Filter Respirator

GB2626

93.76

20.00

2020-78.4pdf icon

Dongguan   Oukangda Medical Technology Co., Ltd.

Kangerda KN95   Particulate Respirator

EN149, GB2626

93.68

90.28

2020-78.5pdf icon

Dongguan Xianda   Medical Equipment Co., Ltd.

KN95 Protective   Mask

EN149, GB2626

35.00

24.10

2020-23.1pdf icon

Dongguan Xianda   Medical Equipment Co., Ltd.

KN95 Protective   Mask

GB2626

99.63

99.47

2020-120.1pdf icon

Flyhorse   Industrial Co., Ltd.

FL 0616

EN149

92.58

90.18

2020-75.1pdf icon

Gaomi City   Hancheng Personal Protective Products Co., Ltd.

Baokangjie 9001

GB2626

99.15

98.19

2020-57.3pdf icon

Garry Galaxy   Biotechnology Co., Ltd.

Respirator Mask   With TruTone Technology

GB/T 32610

44.30

35.20

2020-119.1pdf icon

Guangdong Energy   Fortress Pharmaceutical Co., Ltd.

KN95 Protective   Respirator

GB2626

100.00

95.36

2020-77.2pdf icon

Guangdong Fei   Fan Mstar Technology LTD

Purvigor KN95

EN149, GB2626

68.83

61.60

2020-10.2pdf icon

Guangdong   Medical Technology Co., Ltd.

KN95 Stereo   Protective Mask

EN149

99.18

97.91

2020-102.1pdf icon

Guangdong Nafei   Industrial Holding Co., Ltd.

Efficient   Nursing Protective Mask

EN149, GB2626

10.50

1.10

2020-78.8pdf icon

Guangdong Nafei   Industrial Holding Co., Ltd.

NAFY Protective   Mask

EN149

20.40

13.90

2020-63.1pdf icon

Guangdong   Nuokang Medical Technology Co., Ltd.

KN95-Certified   Particulate Respirator

GB2626

98.73

24.22

2020-60.1pdf icon

Guangdong Qian   Jing Testing Co., LTD.

DNW Protective   Mask

EN149, GB2626

76.50

69.20

2020-18.1pdf icon

Guangdong   Shantou Machinery

KN95 Mask

EN149, GB2626

49.00

34.70

2020-37.1pdf icon

Guangdong   Zhizhen Biological Medicine Co., Ltd.

KN95   Three-Dimensional
  Protective Respirator

GB2626

89.80

88.70

2020-124.1pdf icon

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

KN95 Protective   Mask

GB2626

99.40

99.21

2020-49.1pdf icon

Guangzhou Harley   Commodity Co., Ltd.

L-103V KN95

GB2626

99.49

99.02

2020-95.1pdf icon

Guangzhou   Huashan Biotechnology Co., Ltd.

GF-Mask KN95   Mask

GB2626

74.90

27.10

2020-78.1pdf icon

Guangzhou   Kangbang Medical Equipment Co., Ltd.

KN95 Mask

EN149

98.86

72.00

2020-68.1pdf icon

Guangzhou Sunjoy   Auto Supplies Co., Ltd.

K1 Self Suction   Filter Respirator

GB2626

43.70

12.30

2020-118.1pdf icon

Guangzhou Tianyi   Zhongliang Biotechnology Group Co., Ltd.

KN95 Disposable   Protective Mask

GB2626

97.29

87.20

2020-65.1pdf icon

Guanyang Yuhan   Textile Co., Ltd.

KN95 Protective   Face Mask

GB2626

56.59

42.15

2020-36.1pdf icon

Hangzhou   Senrunqing Technology Co., Ltd.

KN95 Mask-C

EN149, GB2626

85.90

78.70

2020-67.1pdf icon

Henan Kang   Medical Devices Co., Ltd.

KN95 Protective   Mask – KS16

GB2626

97.50

52.10

2020-97.1pdf icon

Honeywell Safety   Products (Shanghai) Co., Ltd.

H801 Particulate   Respirator

GB2626

99.32

98.40

2020-61.1pdf icon

Huabai

9501

GB2626

97.07

69.00

2020-29.3pdf icon

Huizhou Huinuo   Technology Co., Ltd.

HV-N 9501B   (Non-Sterile Mask)

GB2626

96.55

88.81

2020-22.2pdf icon

Huizhou Huinuo   Technology Co., Ltd.

HV-N White KN95

GB2626

94.98

90.58

2020-113.1pdf icon

Huizhou Zhongna   Medical Technology Co., Ltd

Anysound KN95   Self-Priming Filter Anti-Particle Respirator

EN149, GB2626

83.41

77.30

2020-56.3pdf icon

Jiande Chaomei   Daily Chemicals Co., Ltd.

CM 9527

GB19083

99.29

97.87

2020-39.1pdf icon

Jiande Chaomei   Daily Chemicals Co. Ltd.

F-Y3-A Medical   Protective Masks

GB19083

99.68

97.75

2020-77.3pdf icon

Jiande Chaomei   Daily Chemicals Co. Ltd.

6005-1

GB2626

99.19

98.73

2020-110.1pdf icon

Jiangmen Huayue   Industrial Co., Ltd.

HY9501 Folding   Mask – KN95

GB2626

99.55

98.48

2020-72.1pdf icon

Jiangsu Homcan   Medical Technology Co., Ltd.

HC-NP95A   Self-Priming Filter

EN149

51.80

17.20

2020-66.2pdf icon

Jiangsu Jiton   Clothing Corporation

JT-KN95 Reusable   and Sterilizable Nano-mask KN95

EN149

96.74

91.61

2020-10.1pdf icon

Jiangsu Newborn   Medical Technology Co., Ltd.

Protective Mask   KN95

GB2626

97.07

50.70

2020-113.2pdf icon

Jinhua Jiadaifu   Medical Supplies Co., Ltd.

KN95 Face Mask   (Non-Medical)

GB2626

99.57

54.90

2020-113.3pdf icon

Jining Jianda   Medical Device Technology Co., Ltd.

PM2.5 KN95

EN149, GB2626

64.80

59.60

2020-21.3pdf icon

Kindly Care   Products Co., Ltd.

Y-9500

GB2626

91.64

89.80

2020-66.1pdf icon

Kindly Care   Products Co., Ltd.

Y-9500

GB2626

90.71

88.20

2020-79.1pdf icon

King Year and   Packaging Co., Ltd.

Self-Breathing   Filtration Particle-Preventive Respirator

EN149, GB2626

90.03

82.70

2020-62.2pdf icon

King Year and   Packaging Co., Ltd.

Self-Breathing   Filtration Particle-Preventive Respirator

EN149, GB2626

91.12

83.40

2020-62.1pdf icon

Kuangye   (Dongguan) Technology Co., Ltd.

Geyou KN95   Environmental Protective Respirator

GB2626

97.10

13.60

2020-78.2pdf icon

Laianzhi

KLT01

GB2626

99.68

97.83

2020-06.2pdf icon

Lamdown

SD-KN95

GB2626

99.22

89.60

2020-71.1pdf icon

Lanshan Shendun   Technology Co., Ltd.

SD-KN95

GB2626

98.14

94.91

2020-80.1pdf icon

Lanshan Shendun   Technology Co., Ltd.

SD-KN95

GB2626

99.71

66.80

2020-69.1pdf icon

Liaoning Shengjingtang   Biotechnology Co., Ltd.

Medical   Protective Mask N95

GB19083

98.74

96.71

2020-20.1pdf icon

LitezAll

Wanning   Protective Mask

GB2626

98.14

43.00

2020-56.2pdf icon

Nantong   Gold-Sufang Weaving Co. Ltd.

KN95 Face Mask

GB2626

93.39

84.20

2020-56.1pdf icon

Ningbo Green   Health Science Technology Co., Ltd.

KN95 Protective   Mask

GB2626

45.80

33.20

2020-54.1pdf icon

Ningbo Green   Health Science Technology Co., Ltd.

Disposable   Protective Mask (Non-Medical)

GB2626

23.90

11.20

2020-117.1pdf icon

Ningbo YiXin   Intelligentized Science and Technology Co. Ltd.

KN95   (Non-medical)

GB2626

59.50

53.20

2020-86.2pdf icon

Purvigor

KN95   Antibacterial Mask

GB2626

74.20

69.80

2020-33.1pdf icon

Qingdao Hainuo   Bioengineering Co., Ltd.

Hynaut KN95   Protective Face Mask

GB2626

98.37

97.98

2020-96.1pdf icon

Qingdao Maysheng   Medical Devices Co., Ltd

KN95 Protective   Mask
  (Self Suction Filter Respirator FFP2)

GB2626

99.59

99.30

2020-45.1pdf icon

Rizhao Sanqi   Medical Health Articles Co., Ltd.

3Q 9505

GB2626

99.39

96.95

2020-29.1pdf icon

San Jiao

JS95-01

EN149

89.00

82.40

2020-104.1pdf icon

Scotics Science   Technology Co.

SKSS Sterile N95

GB19083

97.36

96.65

2020-22.1pdf icon

Shandong Tricol   Marine Biological Technology Co., Ltd.

KN95 Particulate   Respirator for PPE
  with Headstrap + Hook

GB2626

99.57

98.71

2020-115.1pdf icon

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3B

USA (claimed, 42   CFR 84)

99.76

99.67

2020-57.1pdf icon

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3X

USA (claimed, 42   CFR 84)

99.95

99.58

2020-57.2pdf icon

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3B-1

GB2626

99.92

99.83

2020-77.1pdf icon

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3X (Sample   Group 1 of 3)

USA (claimed, 42   CFR 84)

99.66

98.32

2020-94.1pdf icon

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3X (Sample   Group 2 of 3)

USA (claimed, 42   CFR 84)

99.63

99.31

2020-94.2pdf icon

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3X (Sample   Group 3 of 3)

USA (claimed, 42   CFR 84)

99.76

99.34

2020-94.3pdf icon

Shanghai Dasheng   Health Products Manufacture Co., Ltd.

DTC3X

USA (claimed, 42   CFR 84)

99.84

99.45

2020-119.2pdf icon

Shanghai Gangkai   Purifying Products Co., Ltd.

8012

GB2626

99.13

98.11

2020-58.1pdf icon

Shanghai   Huaxiang Woolen Dressing Co., Ltd.

Disposable Mask

GB2626

98.51

97.48

2020-53.1pdf icon

Senke   Pharmaceutical (Chengdu) Co., Ltd.

KN95 Non-Powered   Air-Purifying Particulate Respirator

EN149, GB2626

98.36

92.19

2020-78.9pdf icon

Shenzhen Hangsen   Star Technology Co., Ltd.

Alchemy KN95   Face Mask A1

EN149, GB2626

92.77

56.00

2020-84.1pdf icon

Shenzhen Kawang   Network Technology Co., Ltd.

FFP3

EN149

99.17

98.77

2020-21.2pdf icon

Shenzhen Meili   Medical Devices Co., Ltd.

KN95 Protective   Mask

EN149, GB2626

98.29

58.40

2020-90.1pdf icon

Sinpup Health   (Shenzhen) Co., Ltd.

Face Mask KN95

EN149, GB2626

74.30

43.10

2020-90.2pdf icon

Suzhou Jinruida   Protective Equipment Co, Inc.

KN95 Three   Dimensional Respirator

GB2626

99.31

97.87

2020-34.1pdf icon

Te Yin

TY0929 FFP2 NR

EN149

99.70

98.89

2020-43.1pdf icon

Tongcheng   Chengfeng Protective Equipment Co., Ltd.

Wanhuizhong   Anti-Dust Respirator

GB2626

59.20

32.50

2020-98.1pdf icon

UNKNOWN

UNKNOWN

GB2626

99.60

98.14

2020-29.2pdf icon

UNKNOWN

KN95 Ear Face   Mask

EN149, GB2626

93.60

91.55

2020-42.1pdf icon

UNKNOWN

KN95 Daily   Protective Mask

GB2626

97.08

84.80

2020-56.4pdf icon

UNKNOWN

KN95 Protective   Mask

GB2626

68.90

14.80

2020-67.2pdf icon

UNKNOWN

KN95

UNKNOWN

90.50

34.60

2020-70.1pdf icon

UNKNOWN

Haze Mask KN95

EN149, GB2626

81.20

78.10

2020-82.1pdf icon

UNKNOWN

PLOW KN95

GB2626

91.05

66.40

2020-15.1pdf icon

Xiamen Lixia   Medical Technology Co., Ltd.

Lixia Medical   Respirator

GB2626

99.96

99.31

2020-78.10pdf icon

Xiamen Luan’an   Protective Equipment Co., Ltd.

Eversafe KN95   Self-Priming Filter Respirator

GB2626

98.16

97.56

2020-109.1pdf icon

Zhandjiagang   Meijie Commodity Co., Ltd

MJ-N02A   (Particulate Respirator)

GB2626

99.47

98.55

2020-26.1pdf icon

Zhangjiagang   Zhiyi Medical Materials Co.

Self-Priming   Filter Respirator KN95

GB19083

99.26

97.93

2020-13.1pdf icon

Zhejiang Allta   Industrial Co., LTD

ALLTA Respirator   9591

GB2626

98.08

93.61

2020-32.1pdf icon

Zhejiang Kanghao   Medical Instruments Co., Ltd.

KN95 Respirator

GB2626

50.20

28.30

2020-78.7pdf icon

Zhejiang Lv Mei   Biotech Co.

BeBetty   Particulate Respirator

GB2626

98.71

97.10

2020-56.5pdf icon

Zhejiang Xingxin   Medical Techology Co., Ltd.

KN95 Protective   Face Masks

GB2626

98.81

90.93

2020-78.6pdf icon

Zhongshan   Cassiey Biotechnology Co., Ltd.

N95 Masks +   Particulate Protection Respirator

EN149, GB2626

49.50

41.50

2020-92.1pdf icon

[來源：91儀器信息網(wǎng)譯] 未經(jīng)授權(quán)不得轉(zhuǎn)載 美國FDA口罩