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Gown Test Package

FromUS$90

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Service Scope

Medical gowns are typical medical devices in the market. Medical gowns are usually used in the medical environment to protect the patients from infection or prevent contamination brought by the healthcare workers.

SGS provide basic physical performance and quality test suggestions for medical gown products based on mandatory standards in related markets. Critical tests for gowns include the viral penetration test, linting test and microbial penetration resistance. Besides, the strength and durability of the gowns are also evaluated.

Please choose the corresponding product type and test type base on your need. If any query, please feel free to contact us

Product Type

  • Surgical Gown (ASTM F2407 , ANSI/AAMI PB70)
    Suggested for US Surgical Gown. According to FDA classification, a surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter. Because of the controlled nature of surgical procedures, critical zones of protection have been described by national standards. The critical zones of surgical gowns include the front of the body from the top of shoulders to knees and the arms from the wrist cuff to above the elbow.
  • Isolation Gown (ASTM F3352 , ANSI/AAMI PB70) 
    Suggested for US Surgical Isolation Gown. According to FDA classification, surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns. All areas of the surgical isolation gown except bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated. All seams must have the same liquid barrier protection as the rest of the gown.  Additionally, the fabric of the surgical isolation gown should cover as much of the body as is appropriate for the intended use.

Remark: Level Selection for Surgical Gown (ASTM F2407 , ANSI/AAMI PB70) & Isolation Gown (ASTM F3352 , ANSI/AAMI PB70) 
Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit
Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases
Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery,  when pathogen resistance is needed or infectious diseases are suspected (non-airborne)

  • Surgical Gown/Drape (EN 13795-1)
    Suggested for EU market.

Test Plan

Sample Size 
It will be advised in order confirmation email upon purchase

Turnaround Time (working days)
Basic Physical – 5 Days (Regular) /
Basic+Quality Physical – 39 Days (Regular) / 
Chemical (7 Days)

Test Description

Basic Physical
The basic physical test plan covers the basic barrier effectiveness performance tests according to ANSI/AAMI PB 70.
This test plan is only available for the US market.

Basic Physical & Quality Test
Our physical test package consolidates the most common physical performance tests applying to gown products.

  • Barrier effectiveness
  • Linting test
  • Durability test
  • Fabric strength test
  • Biocompatibility test

The test items will be adjusted depending on your product type and marketplace

Basic Chemical Test (#composite test)
Our chemical test package includes the basic hazardous chemicals based on material type and market recall risks.

  • Total Heavy Metals
  • Phthalates
  • Formaldehyde
  • Azo dye
  • pH value
  • PAHs
  • PFCs

The test items will be adjusted depending on the marketplace and actual sample. The option is available only for European market. For export to US, please contact us for assistance.

Remarks

The test items will be adjusted depending on your product type and age range. Only specific test items will be applied on selected product type, test type and destination market. Detailed test item list will be included in order confirmation email upon purchase.

To quote an even more comprehensive assurance plan for your product, please contact us.

Strengths & benefits


Regulatory Experts
Ensure your product compliance with specific countries’ requirements


Global Network
Provide worldwide coverage and access to all key locations & markets

Order flow

1. Check Out

Confirm selections and fill in contact info

2. Arrange Payment

Pay by credit card or bank transfer offline​

3. Confirm Test Plan

Confirm test and product details

4. Send Sample

Send the sample with printed form

5. Receive Report

Receive our test report by email

Payment

Online Payment
  • We accept VISA, MASTERCARD and AMERICAN EXPRESS
  • Order acknowledgment email will be sent to you by system after successful payment
  • Order confirmation email with service details will be sent to you within 1 working day by our specialist
Offline Payment
  • We accept T/T bank transfer payment
  • Order acknowledgment email with bank details for payment will be sent to you by system after order submission
  • Please arrange payment and send payment receipt to our specialist by email
  • Order confirmation email with service details will be sent to you after payment verification by our specialist

FAQs

You can add them to shopping cart and proceed to checkout for placing your order online. You will receive an order acknowledgment with order details after online order.

It is not necessary to create an account for online purchase, you can select Guest Checkout to place an order without an account.

However, creating an account offers additional benefits:

  • Your contact information will be saved securely for a faster checkout
  • Track your order status and history

If you place an order as a guest, please check our notifications at your email box. Please remember to check promotional and junk mail box if you can’t find it.

If you place an order as a member, please log in and check the status of your order under “Quote Request” or “Orders”.

SGS TIC Mall only accepts US$ for checkout.

You will receive a test application form, sample requirement and delivery details in confirmation email upon successful payment, please complete the form and send the required sample(s) to our competence center in Hong Kong.

Please contact your dedicated specialist to submit your request. It will be reviewed case by case depending on the order process.

No, you can’t cancel and refund the paid order unless there is a quality or service delivery issue.

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