Many Importers are looking into surgical mask importation business in response to market demands

Updated: Apr 2, 2020

As hospital stocks of protective gear dwindle, a mix of opportunists, Good Samaritans, and hustlers are in a mad dash to fill the need.


The US is in a huge shortage of personal protective equipment such as surgical masks, eye shields, surgical gowns, gloves, etc. The fast-changing situation has created a wild frenzy of activity among manufacturers, importers, entrepreneurs, speculators, and Good Samaritans hoping to grab a piece of the thawing market as soon as possible. If you go to Alibaba.com, you will find more than 35000 separate listings of N95 masks! And a lot of manufactures normally sell scoters, barbecue grills, shoes are suddenly hawing masks! How do i know who sells legit products?


So is it very easy to import face masks? Does face mask require FDA approval first? Is it true that Trump waives the duty to face mask and other similar medical devices? I take some time researching this topic and going to share it with you.


Surgical Face Mask and N95 Respirators are Medical Devices if they are intended for medical use



To import medical devices, the shipment and importers must meet the regulatory requirements of both the U.S.Bureau of Customs and Border Protection (CBP) and the Food Drug Administration ( FDA). To import medical devices, the following information is needed


  1. The manufacture needs to register FDA # and must meet applicable regulation

  • Establishment registration

  • Medical Deice listing

  • Quality System

  • Premarket Notification (510k), unless exempt or premarket approval ( pre-market# is needed as part of customs clearance and surgical mask and N95 respirators need pre-market# )

  • Labeling

  • Medical Device Reporting


2. Device Listing number ( D number) is needed


3. An initial importer must be set up in the US regardless of the incoterm. Initial importer, by definition, is " importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations". To become eligible medical device initial importer, you must register on the FDA website and pay the annual fee. In 2020, the registration fee is 5236.00 USD. Obviously you can sell other medical devices other than surgical face masks once you become an initial importer, but if you just want to make quick money, it is your call to judge if worthwhile to pay this annual fee. After you complete registration, you would get a 7 digit import number


https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing


However, with respect to the importation of KN95 masks, Face Masks and KN95 Respirators Not Intended for a Medical Purpose are not required to be transmitted to FDA and can be disclaimed. As long as these products are not intended for medical use then no additional registration would be needed. This is a very fluid situation and the guidance can change at any time. Refer to the most current CSMS 42168200 Information for filing Personal Protective Equipment and Medical Devices during COVID 19.


List of FDA Approved Manufacturers

The situation is complicated by the fact that many factories don’t have proper certification from the FDA or CDC produce surgical masks or N95 respirators. Getting those certifications is a lengthy and expensive process, and the special fabric that filters out tiny particles have been in extremely short supply. So many fly-by-night factories have been pumping out counterfeit or incomplete masks. Here is the website you can check if the manufacture has FDA registration number


https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm


for example, you typed the company name " 3M" and search, you will find 3M updated FDA registration number.






Duty rate of Face Masks


The applicable subheading for the surgical masks, N95 Respiratory will be 6307.90.9889 HTSUS, which provides for other made up textile articles, other. The rate of duty will be 7% ad valorem.


Recent Section 301 additional Annex waive the additional 25% tariff by inserting the 9903.88.42 number. Therefore importers do not need to pay the additional 25% duty but they still need to pay a 7% duty rate of FOB invoiced value. Some people tell me the surgical face mask is duty-free with new policy now. It is not true. We have to be careful about the information we heard.


In addition, the following items are also exempt from section 301 duty rate


1) Bowls of molded plastics, with clips for retaining guide wires during surgical procedures (described in statistical reporting number 3926.90.9990 ) 5.3%


2) Disposable graduated medicine dispensing cups of plastics (described in statistical reporting number 3926.90.9990) 5.3%


3) Pads of foam plastics, with hook and loop fastener straps, integrated arm protectors, and accessory headrest, body straps, lift sheets, hand grips and face masks, of a kind used for positioning patients during medical procedures (described in statistical reporting number 3926.90.9990) 5.3%


4) Single-use sterile drapes and covers of plastics, of a kind, used to protect the sterile field in surgical operating rooms (described in statistical reporting number 3926.90.9990) 5.3%


5) Sterile decanters of polystyrene plastics, each of a kind used to transfer aseptic fluids or medication to and from sterile bags, vials or glass containers (described in statistical reporting number 3926.90.9990) 5.3%


6) Cold packs consisting of a single-use, instant, endothermic chemical reaction cold pack combined with a textile exterior lining (described in statistical reporting number 6307.90.9889) 7%


7) Disposable shoe and boot covers of man-made fiber fabrics (described in statistical reporting number 6307.90.9889) 7%


8) Eye compresses, each consisting of a fabric cover filled with silica or gel beads, with or without a hook-and-loop fastener strap (described in statistical reporting number 6307.90.9889) 7%


9) Face masks, single-use, of textile fabrics (described in statistical reporting number 6307.90.9889) 7%


10) Gel pads of textile materials, each with removable fabric sleeves, in the shape of hearts, circles or quadrants (described in statistical reporting number 6307.90.9889) 7%


11) Hot packs of textile material, single-use (exothermic chemical reaction) (described in statistical reporting number 6307.90.9889) 7%


12) Laparotomy sponges of cotton (described in statistical reporting number 6307.90.9889) 7%


13) Patient restraint or safety straps of textile materials, with hook-and-loop or ladder lock fasteners (described in statistical reporting number 6307.90.9889) 7%


14) Single-use blood pressure cuff sleeves of textile materials (described in statistical reporting number 6307.90.9889) 7%


15) Single-use medical masks of textile material (described in statistical reporting number 6307.90.9889) 7%


16) Single-use stethoscope covers (described in statistical reporting number 6307.90.9889) 7%


17) Woven gauze sponges of cotton in square or rectangular sizes (described in statistical reporting number 6307.90.9889) 7%


18) Electromechanical shoe cover dispenser, of steel (described in statistical reporting number 8479.89.6500) 2.8%


19) Protective articles (described in statistical reporting number 9004.90.0000) 2.5%


All types of Surgical Face Mask FDA product code

Below is needed as part of entry summary data needs to be submitted to FDA

  • Surgical Mask With Antimicrobial/Antiviral Agent Surgical Apparel

Product code: OUK

Regulation number: 878.4040

Review Panel: General Hospital

  • Strap, Head, Gas MaskGas Mask Head Strap 510(K) Exempt

Product code: BTK

Regulation number 868.5560

Review Panel: Anesthesiology


  • Pediatric/Child FacemaskSurgical Apparel

Regulation number: 878.4040

Product code: OXZ

Review Panel: General Hospital


  • RFG Microelectronic Mask Or Chip Processing, Checking, And/Or Repair not classified

Product code: RFF


  • Masker, Tinnitus

Regulation number: 874.3400

Product code KLW

Review Panel: Ear Nose & Throat


  • Mask, Ventilator, Non-Continuous, Reprocessed Noncontinuous Ventilator (IPPB)

Regulation number: 868.5905

Product code: NMC

Review Panel: Anesthesiology


  • Mask, Surgical Surgical Apparel

Regulation number 878.4040

Product code: FXX

Review Panel: General Hospital


  • Mask, Scavenging Scavenging Mask 510(K) Exempt

Regulation number:868.5590

Product code: KHA

Review Panel: Anesthesiology


  • Mask, Oxygen, Non-Rebreathing Nonrebreathing Mask 510(K) Exempt

Regulation number: 868.5570

Product code: KGB

Review Panel: Anesthesiology


  • Mask, Oxygen, Low Concentration, VenturiVenturi Mask 510(K) Exempt

Regulation number: 868.56001

Product code: BYF

Review Panel: Anesthesiology


  • Mask, Gas, Anesthetic Anesthetic Gas Mask 510(K) Exempt

Regulation number: 868.5550

Product code: BSJ

Review Panel: Anesthesiology


  • Humidifier, Respiratory, Mask (Direct Patient Inte ...Respiratory Gas Humidifier

Regulation number:868.5450

Product code: OBN

Review Panel: Anesthesiology






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