FDA Surgical and Non-Surgical
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This document provides information about surgical and non-surgical isolation gowns manufactured to meet FDA-recognized ANSI/AAMI PB70 Level 1-3 guidelines. It details pricing starting at $2/gown for Level 1 and $2.75/gown for Level 2. Gowns are produced in FDA-certified factories in Turkey or China and coordinated by experienced Turkish textile engineers. Production capacity is 1 million Level 1 gowns/week from China and 250,000 Level 2/3 gowns every 14 days from Turkey.
FDA Surgical and Non-Surgical
- 1. BUYERS GUIDE TO NON-SURGICAL AND SURGICAL GOWNS MANUFACTURED TO MEET FDA-RECOGNIZED ANSI/AAMI PB70 LEVEL 1-3 GUIDELINES
- 2. HEALTHCARE ORGANIZATIONS ARE LOOKING FOR TRUSTED PARTNERS IN THE PERILOUS PPE PROCUREMENT ENVIRONMENT During the COVID Crisis, OmniChannel Health is here to help. We have used our extensive and long-term relationships to supply healthcare organizations with the PPE they need: High-quality products at fair prices. Gowns are Manufactured In Turkey or China in FDA-certified factories PRICING AAMI Level 1: Starting at $2.00 AAMI Level 2: Starting at $2.75 AAMI Level 3: Starting at $4.00 (Reusable Surgical Gowns) BUYERS GUIDE TO NON-SURGICAL AND SURGICAL GOWNS MANUFACTURED TO MEET FDA-RECOGNIZED ANSI/AAMI PB70 LEVEL 1-3 GUIDELINES
- 3. FOUNDER & CEO JONATHAN JARASHOW Harvard College, AB 1990, Magna Cum Laude In 1995, I started publishing a niche diabetes magazine for pharmacies. It became the largest circulation diabetes magazine in the US. We printed and distributed over 100 million diabetes and health-related magazines at Walgreens, Walmart, CVS and other leading pharmacy chainsin addition to other health magazines and media. I now use my two decades of experience to advise healthcare organizations and companies around the globe, and I am proud to be a CDC National Hypertension Control Roundtable Member. During the COVID Crisishelping companies source high quality, fairly-priced PPE. ABOUT US jonathan@hcrimson.com (917) 838-4967
- 4. COORDINATORS FOR GOWN PRODUCTION AND LOGISTICS OUR TWO EXPERIENCED TURKISH TEXITLE ENGINEERS WHO INSPECT EVERY BOX BEFORE SHIPMENT TO THE USA TO ENSURE PROPER QUALITY AAMI Level 2 Gowns Pictured Here
- 5. FDA REGISTRATION, CERTIFICATIONS AND TECHNICAL DATA FOR OUR PRIMARY TURKISH MANUFACTURER BUYERS GUIDE TO NON-SURGICAL AND SURGICAL GOWNS MANUFACTURED TO MEET FDA-RECOGNIZED ANSI/AAMI PB70 LEVEL 1-3 GUIDELINES
- 6. AAMI EQUIVALENT* TESTING REPORTS FOR OUR PRIMARY TURKISH MANUFACTURER * Source: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns
- 7. NON-SURGICAL ISOLATION GOWN AAMI LEVEL 2 FROM OUR PRIMARY TURKISH MANUFACTURER Nonwoven SMS Spunbond Fabric Up to 40 GSM No Lamination Waterproof, Breathable* (Disposable) * Breathability is superior to most Chinese-manufactured gowns which are PP + PE, not SMS. BUYERS GUIDE TO NON-SURGICAL AND SURGICAL GOWNS MANUFACTURED TO MEET FDA-RECOGNIZED ANSI/AAMI PB70 LEVEL 1-3 GUIDELINES
- 8. OPTIONS Gown 50 Nonwoven SMS Spunbond Fabric 40 GSM + 10 GSM Lamination Chest and Arms Laminated (Resuable) Gown 80 Carded Chemicals Bonded Viscose Based, 54 GSM, Fully Laminated, Non-Breathable, Waterproof (Resuable) Gown 100 Carded Chemicals Bonded Viscose Based, 65 GSM, Double Laminated Non-Breathable, Waterproof (Resuable) SURGICAL GOWNS AAMI LEVEL 3 (REUSABLE) FROM OUR PRIMARY TURKISH MANUFACTURER BUYERS GUIDE TO NON-SURGICAL AND SURGICAL GOWNS MANUFACTURED TO MEET FDA-RECOGNIZED ANSI/AAMI PB70 LEVEL 1-3 GUIDELINES
- 9. AAMI LEVEL 1 ISOLATION GOWNS TIMELINE CURRENT PRODUCTION CAPACITY FROM PRIMARY MANUFACTURER IN CHINA: 1,000,000 gowns per week SHIPPING TIME BY SEA CONTAINER FROM CHINA TO USA: Approximately 14 days from completion of gowns with expedited shipping using matson.com These times are estimates based on current market conditions. We will update you regularly if there are any anticipated delays. AIR FREIGHT TIME FROM CHINA TO USA: Approximately 1 week from completion of gowns. We generally offer excellent rates for air freight from China. DISCLAIMER: WE DO NOT OFFER ANY INSPECTION SERVICES FOR LEVEL 1 GOWNS BUYERS GUIDE TO NON-SURGICAL ISOLATION GOWNS MANUFACTURED TO MEET FDA-RECOGNIZED ANSI/AAMI PB70 LEVEL 1-3 GUIDELINES
- 10. AAMI LEVEL 2/3 GOWNS TIMELINE CURRENT PRODUCTION CAPACITY FROM PRIMARY MANUFACTURER IN TURKEY: Minimum of 250,000 gowns every 14 days. SHIPPING BY SEA CONTAINER FROM TURKEY TO USA: Via MSC @ msc.com, a world leader in global container shipping. Approximately 21 days from completion of gowns. These times are estimates based on current market conditions. We will update you regularly if there are any anticipated delays. If gowns are needed sooner, we can utilize our other FDA-certified factories in Turkey and/or China. BUYERS GUIDE TO NON-SURGICAL ISOLATION GOWNS MANUFACTURED TO MEET FDA-RECOGNIZED ANSI/AAMI PB70 LEVEL 1-3 GUIDELINES