The FDA certification and registration agency for goggles needs to go through the FDA registration for the export of goggles to the United States. You can come to the third-party testing agency of our company's information technology department to handle the registration. Goggles are an important part of personal protective equipment, which can be divided into ordinary goggles and special goggles according to the use function.
Protective glasses is a special type of glasses, which is designed to prevent radiation, chemical, mechanical and different wavelengths of light damage. There are many kinds of protective glasses, and the glasses with different needs in different occasions are also different. The common ones are dust-proof glasses, shock proof glasses, chemical proof glasses and radiation proof glasses.
Glasses products exported to the United States, such as myopia glasses, presbyopia glasses, sunglasses, protective glasses, lenses, frames, magnifying glasses, contact lenses, etc., need to apply for FDA registration. Contact lenses are classified into two categories according to their performance. 510k pre market evaluation documents are required for class a products.
Applicants can be producers, exporters, packaging, U.S. importers, etc. The procedure is: submit the application, pay the annual fee, pay the agent service fee, register and obtain the FDA registration number. Before the glasses are exported, they also need to pass the drop ball testing, that is, the impact test.
FDA shall meet 21 CFR 801.410 lens drop ball test for lenses (sunglasses, presbyopic glasses, protective glasses, etc.) exported to the United States. FDA drop ball test, English: drop ball test or impact resistance test, Chinese: drop ball test or impact resistance test. What is FDA drop and drop test? Place a steel ball on the convex surface of the lens from a certain height, and observe whether the lens is broken. FDA is used to measure the impact resistance of lenses. FDA mainly tests the lens. During the test, it will use a fixture to stand up the lens frame for drop test.
Manufacturers of impact resistant lens related products should pay attention to not only providing all FDA manufacturers and product registration numbers, but also providing the following quality inspection documents of the factory batch (many US customs have applied this requirement for many years) when they are exporting the relevant goods to the United States
Certification statement of impact resistance manufacturer's declaration of conformity (that is, the document signed by the person in charge of the manufacturer who has conducted impact test / ball dropping test before delivery according to the statement of FDA regulations and passed the test and sworn to FDA)
Impact Resistance Test Report Impact test report (also known as the drop test report; the drop test is the basic test for the final batch inspection of all the above-mentioned relevant lenses before delivery to prove that the batch of products exported to the United States meet the requirements of impact resistance standards and are qualified; generally, the test report is only provided when the relevant customs specifically require it, and the above statement can be used as the certificate of compliance)
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