U.S. Surgical Gown & Drape Production · IIJA / Make PPE in America

U.S. gown production, launching 3Q 2026.

Hilo Industries is bringing automated, IIJA / Make PPE in America–aligned surgical gown production to the United States. Today we manufacture the gowns and drapes inside nationally distributed custom procedure trays — in acute-care hospitals and ambulatory surgery centers coast to coast through some of the largest medical device and distribution companies in the country — with individually packaged sterile gowns for the shelf.

Request Specifications How We Supply
Ultra Reinforced Surgical Gown — AAMI PB70 Level 4
Ultra Reinforced Surgical Gown · AAMI PB70 Level 4
3
AAMI PB70 Level 3Standard Surgical Gown
4
AAMI PB70 Level 4Ultra Reinforced Gown
FDACLEARED
FDA-ClearedSurgical gowns, U.S. sale
STERILE EO
EO SterilizedSingle-sterile series
GS1-128
Full TraceabilityGTIN + lot/expiry barcoded
LATEX
No Natural Rubber LatexNot made with natural rubber latex
3Q26
U.S. production launch — IIJA / Make PPE in America–aligned
3&4
AAMI PB70 liquid-barrier classifications across the line
4
Supply regions — two producing today, two launching now
1
Business day to answer every specification request
How We Supply

Built for the tray. Ready for the shelf.

Kit assemblers and providers buy differently — same gown platform underneath.

Surgical Kits · Our Core

Products That Go Into Custom Procedure Trays

The gowns and drapes inside the custom procedure tray. We supply tray and kit assemblers with components engineered for pack-out — delivered non-sterile in bulk, sterilized as part of your finished kit.

  • Gowns and drapes to your kit specification
  • Consistent fold & dimensions for automated and manual pack-out
  • Bulk case packs, lot-coded with GS1-128 barcoding
  • Program pricing for recurring kit volume
  • We don't assemble kits — we supply the assemblers
Single Sterile

Individually Packaged Sterile

EO-sterilized single units for surgical teams in acute and ambulatory settings — shelf-ready with full spec labeling.

  • 1× sterile gown + 2× hand towels + 1× sterile wrapper per pouch
  • AAMI level shield, REF, size, GTIN, lot & expiry on every unit
  • Case-packed for the supply shelf
  • Sterilized by ethylene oxide (EO)
Products

Gowns and drapes for the surgical case.

Single-use, not made with natural rubber latex, and built to the standards your clinicians already trust.

Standard Surgical Gown

Standard Surgical Gown

AAMI PB70 Level 3 · ASTM F2407

The workhorse surgical gown for the broad run of procedures — SMMS multilayer fabric, knit cuffs, full-coverage back.

Kit-ready or single sterile · Sizes XS–XXXL
Ultra Reinforced Surgical Gown

Ultra Reinforced Surgical Gown

AAMI PB70 Level 4 · ASTM F2407

Reinforced front and sleeve panels for fluid-intensive procedures — the highest AAMI liquid-barrier classification.

Kit-ready or single sterile · Sizes XS–XXXL
FOLDED · KIT-READY

Surgical Drapes & Kit Soft Goods

Kit Components · To Your Specification

Surgical drapes, hand towels, and soft-goods components supplied kit-ready — engineered folds and dimensions your pack-out line can plan around.

Bulk case packs · Lot-coded · GS1-128 barcoded
Our components already ship inside nationally distributed surgical kits. Building a custom pack? We supply gowns, drapes, and soft-goods components to your kit specification — consistent folds, dimensions, and lot traceability your pack-out line can plan around.
Capabilities

Onshore. Near-shore. Offshore.

Supply strategies change — tariffs move, domestic-preference rules tighten, volumes spike. Hilo is launching a three-lane manufacturing platform so your program can shift with them without changing your spec.

01 · ONSHORE · LAUNCHING 3Q 2026

United States

Automated U.S. gown-production lines are in final equipment qualification, with IIJA / Make PPE in America–aligned production officially launching in 3Q 2026 — built for domestic-preference procurement.

02 · NEAR-SHORE · LAUNCHING NOW

North America

Our Baja California platform for sterilization and kitting is launching now — built for short lanes, fast replenishment, and North American supply-chain resilience for kit programs.

03 · OFFSHORE · ACTIVE PRODUCTION

Asia & Mediterranean

High-volume manufacturing across Asia and the Mediterranean — direct ocean lanes into U.S. East Coast ports, mature customs discipline, and landed-cost leadership at scale, with tariff-lane diversity built in.

Quality & Regulatory

Built on the standards. Documented to them.

Every claim on this page maps to a standard, a test method, or a barcode your receiving dock can scan.

Barrier performance & testing
Surgical gowns are classified to AAMI PB70 liquid-barrier Levels 3 and 4 under the ASTM methods that govern those classifications (F1670 synthetic blood penetration; F1671 viral penetration for Level 4), and are specified to ASTM F2407 surgical gown performance requirements. Materials meet Class 1 Normal Flammability under 16 CFR 1610. Per-product test documentation is available to qualified purchasers through the specification request below.
FDA status
Our surgical gowns are FDA-cleared for U.S. sale, with establishment registration and device listing maintained as required. Documentation available to qualified purchasers on request. Facility audits and quality documentation are available to qualified partners under NDA.
Sterilization
Single-sterile units are sterilized by ethylene oxide (EO) in validated cycles, individually pouched with sterile-barrier packaging: 1× sterile gown, 2× hand towels, 1× sterile wrapper. Contents of unopened, undamaged packages are sterile.
Traceability & quality system
Every unit and case carries GS1-compliant barcodes — the device identifier (GTIN) plus production identifiers (lot and expiry) — supporting receiving-dock scan-in and full lot traceability. Quality system aligned to FDA QMSR (21 CFR Part 820 / ISO 13485:2016), with complaint handling and supplier controls.

In hospitals and surgery centers nationwide — today.

Hilo gowns and drapes reach acute-care hospitals and ambulatory surgery centers across the country inside the surgical kits and supply programs of some of the nation's largest medical device and distribution companies.

Request Specifications

Specs within one business day.

Spec sheets, size grids, case configurations, samples, and program pricing are provided on request — tell us who you are and what you're building.

Email
Phone
703.348.4613
Address
Hilo Industries LLC
10432 Balls Ford Rd STE 300
Manassas, VA 20109
Our response promise: every specification request gets a substantive reply from our team within one business day — spec sheets and size grids first, samples and program pricing as your evaluation moves forward.