Malaysia
USA trade laneMalaysia has been the center of the rubber glove industry for decades, with large nitrile and latex glove manufacturers around the Klang Valley and in the northern states supplying hospitals, clinics, laboratories, food processors and distributors worldwide. For US buyers the case for Malaysian supply sharpened on 1 January 2026, when the Section 301 tariff on Chinese medical and surgical rubber gloves reached 100%. Malaysian gloves pay their normal duty plus the 10% Section 301 layer that applies to most Malaysian goods. So most people asking how to import gloves from Malaysia start by finding a nitrile gloves Malaysia manufacturer — and then discover the real work is FDA compliance and supplier due diligence, not freight.
We work through WCA partner agents in Malaysia; AGF has no office there. Before you place an order we check what will decide whether the gloves clear: the 510(k) clearance, the FDA registration and device listing, the manufacturer's status on FDA Import Alert 80-04, and its forced-labor record with CBP. Then we book the container, and our licensed customs brokers file the entry with the FDA data it needs.
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Shipping Medical Gloves & Disposables from Malaysia to USA
Gloves are light, cube-heavy cargo: commonly 100 gloves to a dispenser box and 10 boxes to a carton, so a container fills by volume long before it nears a weight limit. The 40ft High Cube (about 76 CBM) is the standard box. Floor-loaded cartons maximize the count per container; palletized loads cost space but cut receiving time at a distribution center, and many large buyers accept the trade. We plan the load from the supplier's carton dimensions before booking, so the freight cost per case is known in advance.
Heat and humidity are the enemy. Nitrile and latex age faster in heat, so ask for desiccant in the container, avoid long dwell at hot terminals, and receive by lot and expiry date. Port Klang serves the Klang Valley factories and Penang the northern ones; Los Angeles / Long Beach is about 18–24 days port to port on a direct sailing, and the East Coast about 28–38 days.
- 40ft High Cube (about 76 CBM) is standard; floor-loaded for count, palletized for faster receiving
- Lot number, expiry date, FDA labeling and "Made in Malaysia" marking on every carton before loading
- Desiccant and short terminal dwell — gloves degrade with heat and humidity
- LA/LB about 18–24 days direct; East Coast about 28–38 days, confirmed per booking
What Drives the Cost
- Cartons per container — floor-loaded versus palletized changes the freight cost per case
- Duty: the normal rate for the glove line plus the 10% Section 301 layer on Malaysian goods
- FDA holds — a manufacturer on Import Alert 80-04 means detention without physical examination
- Supplier due diligence: forced-labor and labor-audit evidence the factory can produce on request
- Ocean rates on Asia–US services, which swing with the season
- US port choice and inland delivery to your distribution center
HS Codes and Duty Notes
Classification guidance only — duty rates change and depend on your exact product. Our licensed customs brokers verify every code before you commit to an order.
| HS Code | Products | Notes |
|---|---|---|
| 4015.12 | Rubber gloves of a kind used for medical, surgical, dental or veterinary purposes — nitrile and latex examination and surgical gloves | FDA-regulated devices. Malaysian origin pays the normal duty plus the 10% Section 301 layer; the same gloves of Chinese origin have paid Section 301 at 100% since 1 January 2026. Verify the 10-digit line with our licensed customs brokers. |
| 4015.19 | Other rubber gloves — industrial, food-service and household nitrile and latex gloves | Not medical devices unless they are marketed for medical use. Gloves for food handling must be made of materials permitted for food contact. The 10% layer applies to Malaysian origin. |
| 3926.20 | Vinyl (PVC) gloves and other gloves of plastics | Classified as plastics, not rubber. PVC is a priority sector in US forced-labor enforcement, so ask where the resin comes from. Medical vinyl gloves still need FDA clearance. |
| 4014.10 / 9018.39 | Condoms; catheters, cannulae and similar medical disposables | FDA devices, usually Class II requiring 510(k) clearance — check the FDA product code. Duty and Section 301 layer status are confirmed per line. |
Regulations and Compliance
FDA: 510(k), registration and device listing
Patient examination and surgical gloves are medical devices. They are Class I, but not exempt from premarket notification, so each glove needs 510(k) clearance. The Malaysian manufacturer must register its establishment with FDA, list the device and name a US agent, and the customs entry carries the registration, listing and 510(k) numbers as FDA data. Powdered surgeon's and examination gloves have been banned since 2017. Ask for the 510(k) number and check it, and the registration, in FDA's public databases before you pay a deposit — a glove sold as "medical grade" without clearance cannot be sold for medical use in the US.
FDA Import Alert 80-04
Import Alert 80-04 lets FDA detain without physical examination the surgeon's and patient examination gloves of manufacturers listed on it. Gloves are sampled and tested for leaks against FDA's acceptable quality levels, and because defective gloves are a health hazard a single violative sample can be enough to put a manufacturer on the list. Getting off it takes the manufacturer time and evidence. Check the alert before you choose a supplier; if your manufacturer is listed, every shipment can be held until it is shown to comply.
Forced labor: CBP withhold release orders
Between 2019 and 2022 CBP issued withhold release orders against several Malaysian glove makers, some of them among the largest in the industry, over recruitment fees, debt bondage and working conditions. Every one of those orders has since been modified or lifted after the companies remediated. If your supplier was ever named, ask for CBP's modification notice and keep it with your import records; from every supplier, ask for recent labor-audit and recruitment-fee repayment evidence. A new order can be issued at any time, and detained goods sit at the importer's cost.
Section 301: Malaysia versus China
Chinese medical and surgical rubber gloves have carried a 100% Section 301 tariff since 1 January 2026. Malaysian gloves pay their normal duty plus the 10% Section 301 layer in force since 24 July 2026. Origin is where the glove is actually formed — dipped, cured and stripped — so Chinese gloves repacked in Malaysia remain Chinese. CBP looks for exactly that, and since 6 May 2025 only Malaysia's trade ministry, MITI, issues non-preferential certificates of origin for US-bound goods.
Labeling and marking
Device labeling must meet FDA's requirements, and the box and carton must be marked with the country of origin. Lot numbers and expiry dates on every carton are what make a recall or an FDA question manageable — insist on them in the purchase order.
Door-to-Door Import Service
Before you order, we check the manufacturer's 510(k), FDA registration and listing, its Import Alert 80-04 status and its CBP forced-labor history. Our WCA partner agent in Malaysia then arranges collection from the factory, the K2 export declaration in uCustoms and container loading, and the exporter obtains the certificate of origin from MITI where you need one.
From Port Klang or Penang, a direct sailing reaches Los Angeles / Long Beach in about 18–24 days port to port; the East Coast takes about 28–38 days. The ISF is filed before loading, our licensed customs brokers file the entry with the FDA data, and partner carriers deliver to your distribution center — with partner warehousing on standby if FDA holds a shipment for examination.
Frequently Asked Questions
How do I import gloves from Malaysia to the USA?
Do nitrile gloves from Malaysia need FDA approval?
Are Malaysian glove manufacturers still banned by US Customs?
What duty do gloves from Malaysia pay compared with China?
Medical Gloves & Disposables is just one example. AGF ships whatever your business moves — on this lane and beyond. If your commodity isn't covered by one of our guides, tell us what you ship and we'll build the logistics around it.
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