At present, the domestic epidemic is tending to ease, and the number of infected inpiduals in Europe, Italy, Japan, South Korea and other countries continues to rise. Iran has attracted global attention with a very high mortality rate. In view of this, the business opportunity for masks quickly shifted to foreign countries, and mask exports have become a popular business under the current epidemic

Certification requirements for general protective masks in the United States:

According to the FDA Medical Class I certification, the process is:

① Fill out the application form and confirm the information ② Obtain a PIN code and pay an annual fee ③ Issue registration number ④ Product export

Certification requirements for medical surgical masks in the United States:

According to the FDA Medical Class II certification, the process is:

① Product testing (performance testing, biological testing) ② Prepare 510K documents and submit them for FDA review ③ FDA sends a 510K approval letter ④ Complete factory registration and machine listing ⑤ Product export

Certification requirements for 9 types of medical N95 and above masks in the United States:

According to NIOSH certification standards, enterprises need to send samples to NIOSH laboratories for testing, and submit technical materials (including quality system information) to NIOSH for review. After both the review and testing are passed, NIOSH will issue an approval document

EU General Protective Mask Certification Requirements:

The European standards for personal protective masks are EN149 and EN143. Protective masks need to meet the requirements of the EU Personal Protective Equipment Directive (PPE), review the enterprise quality management system and CE technical documents, and obtain CE certificates for PPE regulations after passing the audit

EU Medical Protective Mask Certification Requirements:

The corresponding European standard for medical masks is EN14683. According to the requirements of the Medical Device Regulations 2017/745/EU, mask products can be managed as Class I devices.

. The certification mode varies depending on whether the product is sterile or non sterile

Certification requirements for medical protective masks in Australia and New Zealand:

AS/NZS1716:2012 is a respiratory protection device standard in Australia and New Zealand.

. This standard specifies the procedures and materials that must be used in the manufacturing process of particle masks, as well as the determined testing and performance results, to ensure their safe use

Korean Mask Standards and Certification Requirements

Korean Medical Mask Certification Standards:

The KF (Korean filter) series of mask standards in Korea is produced by the Ministry of Food and Drug Administration of Korea

Function of testing report:

1. Project bidding: Issue authoritative third-party CMA/CNAS qualification report

2. Online e-commerce platform entry: Quality inspection report recognized by major e-commerce platforms

3. Used as a sales report: issuing legally effective testing reports to make consumers more confident

4. Papers and research: Provide professional personalized testing needs

5. Judicial services: providing scientific, fair, and accurate testing data

6. Industrial problem diagnosis: Verify the troubleshooting and correction of industrial production problems

100% inspection and testing process:

1. Telephone communication and confirmation of requirements

2. Recommend solutions and confirm quotations

3. Mail samples and arrange testing

4. Progress tracking and result feedback

5. Provide reports and after-sales service

6. If urgent or priority processing is required

Testing and testing characteristics:

1. The testing industry is fully covered, meeting different testing needs

2. Fully cover the laboratory and allocate localized testing nearby

3. Engineers provide one-on-one services to make testing more accurate

4. Free initial testing, with no testing fees charged

5. Self service order delivery for free on-site sampling

6. Short cycle, low cost, and attentive service

7. Possess authoritative qualifications such as CMA, CNAS, CAL, etc

8. The testing report is authoritative and effective, and is generally used in China