Regulatory & Compliance Documentation
Your procurement team needs confidence. Our White Isolation Gowns are manufactured and tested according to internationally recognized standards.
Standard / Requirement | Our Compliance Status | What It Means for You |
|---|---|---|
AAMI PB70 Level 2 | Certified | |
AAMI PB70 Level 3 | Available upon request | |
FDA 510(k) | Cleared (Class I medical device) | Legal for sale in U.S. healthcare facilities-4 |
ISO 13485 | Certified | Quality management system for medical devices |
Lot Traceability | Each carton labeled with batch number | Full recall readiness and audit compliance |
Third-Party Test Reports | Available per shipment | Verify before you pay — no surprises |
Case Study: Reducing PPE Costs Without Compromising Safety
Client: A 300-bed community hospital (Midwest U.S.)
Challenge: The hospital faced a 200% price increase on isolation gowns during Q4 2022 and experienced frequent stockouts from their previous supplier.-6
Solution: Switched to our White Isolation Gowns (AAMI Level 2) with a 12-month fixed-price contract.
Results (12-month follow-up):
Metric | Before | After | Improvement |
|---|---|---|---|
Gown expenditure | $187,000 | $112,000 | 40% cost reduction |
Stockout incidents | 8x per year | 0x per year | 100% elimination |
Staff compliance rate | 67% | 91% | +24 percentage points |
Infection control audit score | 82/100 | 96/100 | Passed with distinction |
"The consistent quality and reliable delivery have made a real difference in our infection control program. Our staff actually prefer these gowns over the previous brand."
— Director of Supply Chain, client name available upon request
Clinical Evidence: Why Gown Compliance Matters
A peer-reviewed study published in PubMed found that when compliance with gown and glove isolation precautions more than doubled, the rate of nosocomial (hospital-acquired) infections decreased by a factor of 2.9 (95% CI: 1.5 to 5.7).-2
Implication for your facility: Higher-quality gowns → better staff compliance → lower infection rates → reduced liability and treatment costs.
Procurement & Logistics Information
Pricing & Ordering
Order Volume | Price per Unit (USD) | Lead Time | MOQ |
|---|---|---|---|
Sample (1–10 pcs) | Free + shipping | 24 hours | 1 pc |
Small batch (1–10 cases) | To be confirmed based on your volume | 3–5 days | 1 case (100 pcs) |
Bulk (50+ cases) | Contact for quote — contract lock available | 7–15 days | 50 cases |
Container (500+ cases) | Custom pricing — 12-month fixed rate | 20–30 days | 1x40′ HQ |
Shipping & Delivery Options
Method | Regions | Transit Time | Tracking |
|---|---|---|---|
Express (DHL/FedEx/UPS) | Global | 3–7 days | Full tracking |
Air Freight | Global | 7–12 days | Full tracking |
Ocean Freight (FCL/LCL) | North America, Europe, Middle East | 20–40 days | Vessel + container tracking |
Split shipment to multiple addresses | U.S. only | Varies by location | Available |
Payment Terms
T/T (Telegraphic Transfer): 30% deposit, 70% against copy of Bill of Lading
L/C (Letter of Credit): Confirmed irrevocable — available for qualified buyers
Net 30: Available for established accounts (credit check required)
Returns & Warranty
Issue | Resolution |
|---|---|
Manufacturing defect (holes, seam failure, stains) | Full refund or replacement within 30 days |
Wrong item shipped | We pay return shipping + send correct item |
Acceptable Quality Level (AQL) | 1.5 for critical defects; 4.0 for minor defects |
Customer change of mind | Return within 14 days (unopened) — buyer pays return shipping |
Request Free Samples
Why test before you buy?
Conduct your own fluid penetration test
Have your infection control team evaluate comfort and fit
Compare side-by-side with your current gown
What you get:
2–5 free samples (depending on your request)
AAMI PB70 test report for the batch
Product spec sheet
Shipping: You pay shipping for samples outside U.S./Canada; we cover within North America.
Frequently Asked Questions
Q1: What AAMI level are your white isolation gowns?
A: Our standard product is AAMI PB70 Level 2 (spray impact ≤1.0g, hydrostatic pressure ≥20cm).-3 Level 3 is available by special order.
Q2: Do your gowns contain latex?
A: No. Our gowns are 100% latex-free, safe for staff and patients with latex allergies. Powder-free as required by FDA ban (81 FR 91722).-4
Q3: Are the gowns sterile or non-sterile?
A: Our white isolation gowns are non-sterile. For sterile requirements, please contact us for custom orders.
Q4: What is the fabric composition?
A: High-density polypropylene (PP) or SMS (Spunbond-Meltblown-Spunbond) — ≥25 gsm. Opaque even when lightly wet.
Q5: How are they packaged?
A: 10 gowns per bag, 10 bags per carton (100 gowns/carton). Individual wrapping available upon request.
Q6: What is the shelf life?
A: 3 years from manufacture date when stored in original packaging, in a cool, dry environment (below 40°C / 104°F, away from direct sunlight).
Q7: Can I get a certificate of analysis for my specific shipment?
A: Yes. Every carton is labeled with a batch number. We provide CoA per batch upon request.
Q8: Do you ship to multiple hospital addresses from one order?
A: Yes. We support split shipments to up to 10 different addresses within the U.S. and 5 internationally (additional fees apply).
Q9: What is your typical lead time for repeat orders?
A: For existing customers, repeat orders ship within 3–7 days for U.S. and 7–14 days internationally.
Q10: Do you offer contract pricing for long-term commitments?
A: Yes. We offer 6-month and 12-month fixed-price contracts to protect you from market fluctuations. During COVID-19, isolation gown prices increased by up to 2000% — contract pricing prevents this risk.
