Justsun – CE and FDA certified disposable medical supplies and protective nonwoven products manufacturer
Protective gowns · procurement

PPE Protective Gown Procurement Guide

Sourcing isolation gowns and coveralls in bulk — material, AAMI level, certification files, MOQ and lead time.

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01

Match the material to the actual exposure, not the cheapest option

The gown material should follow the real exposure of the task, not a default to the lowest price. SMS nonwoven is breathable and economical for routine isolation where the risk is light splash and contact. PP+PE laminated adds a fluid-proof film barrier and is the common choice for surgical and high-fluid work. CPE/PE film offers maximum impermeability at the lowest cost for high-turnover splash tasks, but it is less breathable and less comfortable for long shifts. Before you specify, list the fluids, the pressure and the duration of exposure — a gown that is over-specified for the task adds cost and heat stress, while an under-specified gown creates a real protection gap.

  • SMS: breathable, economical, routine isolation
  • PP+PE: fluid-proof film barrier for surgery and high fluid
  • CPE/PE: maximum impermeability, lowest cost, less breathable
  • Specify from the actual exposure, not the lowest price
02

Set the AAMI level and the critical zones together

The AAMI PB70 level tells you the fluid-resistance rating, but it does not tell you where that rating applies. AAMI defines critical zones — the front, the sleeves and the seams — where the rated barrier must hold, while the back and non-critical areas may carry a lower barrier. Two gowns with the same level can therefore protect differently depending on how much of the torso the critical zone covers. When you compare gowns for a bulk order, check the critical-zone coverage on the specification sheet alongside the level, and confirm the seam construction matches the fluid risk of the procedure.

  • Level 1–2 suits general care, Level 3–4 for surgery
  • Critical zones are the front, sleeves and seams
  • Check critical-zone coverage, not just the level number
  • Seam construction must match the fluid risk
03

Verify the certification file names the exact model

For export, confirm the gown carries the certification your market requires — CE for Europe and FDA registration for the US. The certification file must name the exact model you are ordering; a certificate that covers a similar but different model is not proof your order is compliant. Check the issuing body, the standard it meets and the validity period, and keep a copy on file for your own customs and market-entry process. If you plan to sell under your own brand, confirm whether the certification can be issued under your brand or remains under the manufacturer's name.

  • Certification must name the exact model you order
  • Check the issuing body, standard and validity period
  • Confirm certification under your brand or the manufacturer's
04

Agree MOQ, packaging and a written production schedule

MOQ and lead time depend on the gown model, material and packaging. Confirm pieces per box, boxes per carton, master carton dimensions and weight before ordering so there are no surprises at shipment. Ask for a written production schedule that separates raw-material arrival, production start, quality inspection and dispatch dates, and build in buffer for sea or air freight to your destination. A single delay in one step should not push your whole launch.

  • Confirm pieces per box and boxes per carton
  • Request a written production schedule
  • Separate production, inspection and dispatch dates
  • Add freight buffer for your destination
Связанные товары

Реальные товары из нашего ассортимента

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SMS Isolation Gown Yellow Knit Cuff – yellow SMS nonwoven isolation gown with knitted cuffs, EN ISO 13795 certified
CE / FDA

Изоляционный халат SMS жёлтый с трикотажной манжетой

Жёлтый одноразовый изоляционный халат из нетканого материала SMS с трикотажными манжетами. Сертифицирован по EN ISO 13795, имеет маркировку CE. Устойчив к разбрызгиванию жидкостей, дышащий, цветовое кодирование по зонам для протоколов инфекционного контроля. 10 шт. в упаковке.

Сертификационный файлView
PP+PE Laminated Isolation Gown White – fluid-proof isolation gown with heat-sealed seams, EN ISO 13795 certified
CE / FDA

Изоляционный халат из ламинированного ПП+ПЭ, белый

Изоляционный халат из ламинированного ПП+ПЭ с влагонепроницаемым барьером и термосварными швами, сертифицирован EN ISO 13795, маркировка CE. Непроницаемый ПЭ-барьер для химиотерапии и процедур с высоким содержанием жидкости, по 10 шт. в упаковке.

Сертификационный файлView
Disposable Coverall with Hood White – full-body SMS nonwoven coverall with integrated hood, CE certified
CE / FDA

Одноразовый комбинезон с капюшоном белый

Полноразмерный одноразовый комбинезон из нетканого материала SMS с интегрированным капюшоном, передней молнией с ветрозащитным клапаном и эластичными манжетами на запястьях и щиколотках. Сертификат CE для реагирования на пандемии, работы с биологическими опасностями и промышленного контроля загрязнений.

Сертификационный файлView
Часто задаваемые вопросы покупателей

Частые вопросы о покупке

What is the difference between SMS, PP+PE and CPE gowns?+

SMS is breathable and economical for routine isolation. PP+PE adds a fluid-proof film barrier for surgical work. CPE/PE film offers maximum impermeability at the lowest cost for splash tasks.

What AAMI level do I need?+

Level 1–2 suits general care, while Level 3–4 is for surgery and high-fluid procedures. Tell us your application and we will recommend the right level and material.

Can I get private-label gowns?+

Yes, we offer OEM and private-label options. Confirm the minimum quantity for custom packaging and branding with our export team.

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Сообщите тип продукции, количество и страну назначения. Наша экспортная команда подтвердит сертификационные файлы, MOQ и срок производства для вашего заказа.

  • Сертификационные файлы CE / FDA
  • MOQ, упаковка и подтверждённый срок производства
  • Варианты OEM / Private label для вашего бренда
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