The US Food and Drug Administration (FDA) has issued an umbrella emergency use authorization (EUA) that sanctions the use of certain surgical masks in healthcare settings. The EUA was issued in response to concerns over the lack of disposable single-use surgical masks for healthcare professionals during the COVID-19 pandemic.

The EUA contains labeling and performance requirements to reduce the risk of unauthorized surgical masks being used.

Key labelling requirements include:

• Description of the product as a disposable, single-use surgical mask. The labeling must include a list of the body contacting materials (which does not include any drugs, biologics, nanoparticles, or antimicrobial/antiviral agents)
• State that the product is not intended to replace the need for FDA-cleared surgical masks or FDA-cleared or authorized respirators
• State that surgical masks are not intended to provide protection against pathogenic biological airborne particulates and are not recommended for use in aerosol generating procedures and any clinical conditions where there is significant risk of infection through inhalation exposure
• Not include statements that would misrepresent the product or create an undue risk considering the public health emergency. For example, the labeling must not include any express or implied claims for: (1) reuse, (2) antimicrobial or antiviral protection or related uses, (3) infection prevention, infection reduction, or related uses, or (4) viral filtration efficiency

These products must also be accompanied by a fact sheet when being used by a healthcare professional.

Specific performance requirements include:

• Fluid resistance requirements (liquid barrier performance) consistent with ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
• Flammability performance consistent with the definition of either a Class 1 or Class 2 textile in 16 CFR Part 1610
• Particulate filtration efficiency requirements consistent with ASTM F2100: Standard Specification for Performance of Materials Used in Medical Face Masks
• Air flow resistance (i.e. breathability) requirements with an acceptance criterion of 6 mm H2O/cm2 for differential pressure (delta P) testing consistent with ASTM F2100: Standard Specification for Performance of Materials Used in Medical Face Masks for those masks composed of 4 or more layers
• Materials of manufacture must conform to either of these requirements:
  • Non-cytotoxic, non-irritating and non-sensitizing consistent with the recommendations in the FDA’s guidance, “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’”
  • Following biocompatibility standards: 
    • ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process 
    • ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity 
    • ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

Not included under the scope of the EUA are surgical masks that are:

• FDA-cleared
• Manufactured in China
• Include drugs, biologics, nanoparticles, or antimicrobial/antiviral agents

EUA can be issued by the FDA during a public health emergency. This EUA was issued on August 5, 2020. To learn more about it, read the original SafeGuard 123/20.  

SGS Medical PPE Services

SGS offers a full range of services to help manufacturers and suppliers of medical PPE deliver high quality, safe, and compliant products to markets around the world. Learn more about SGS Medical PPE Services. 

SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full FDA Issues New Emergency Use Authorization for Surgical Masks SafeGuardS. 

Subscribe here to receive SGS SafeGuardS direct to your inbox.

For further information contact:

Matthew Mcgarrity
Senior Technical Manager
Tel: +1 (973) 461 1505

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Website: www.sgs.com/hardlines

LinkedIn: sgs-consumer-goods-&-retail

About SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

Plymouth, MA, Sep 18, 2020 -- Some executives favor their high school yearbook likeness. Others just choose to ignore the aging process. Either way, an outdated profile photo is not the best way to represent yourself on LinkedIn, the world’s largest professional network.

According to Debi Cramer, founder and principle photographer at Thirty-Eighth Avenue Photography in Plymouth, MA, “There are a number of professional profile photo ‘no-no’s’ including scowling, wearing sunglasses or clothing items with prints, as well as standing alongside other people - or next to someone’s shoulder and arm in the case of a cropped image.”

Professional Image Counts…and May Influence Connections

A LinkedIn profile photo is also not the best place to show off a cherished boat, sports car or pet. It’s okay to wear ski goggles if you’re a ski resort owner, but not okay if you’re a ski enthusiast and your profession is selling life insurance. It should be noted that NOT having a profile photo doesn’t work in your favor either. Will fellow networkers and recruiters want to connect? Perhaps not. Those who do have a profile photo on LinkedIn may receive up to 21 times more profile views than those lacking profile photos (according to LinkedIn).

In an effort to help professionals improve upon their LinkedIn profile photos, Thirty-Eighth Avenue Photography, a commercial and fine art photography studio, is holding an “Ugly LinkedIn Profile Photo” contest now through November 31, 2020.

Three people will be selected for the “Ugly LinkedIn Profile Photo” and will receive a professional portrait taken at Thirty-Eighth Avenue Photography’s new studio at 27 Danforth Lane in Plymouth, MA 02360.

To enter the contest, simply email your LinkedIn URL to Debi Cramer, founder and principle photographer at Thirty-Eighth Avenue Photography, This email address is being protected from spambots. You need JavaScript enabled to view it.. Winners will be notified by email.

To learn more about Cramer and Thirty-Eighth Avenue Photography, visit https://www.38thavenuephotography.com

About Thirty-Eighth Avenue Photography:
Thirty-Eighth Avenue Photography’s new studio includes a client lounge for viewing photos as well as an additional dedicated office space for photo editing and client meetings. Cramer also travels for onsite photo assignments. The agency’s primary focus is commercial photography, event and corporate brand photography - from marketing materials, websites and product pages to headshots.

Debi Cramer, founder and principle photographer at Thirty-Eighth Avenue Photography, has spent many years photographing people, places and things all over the world. With a background in fine arts, textile and graphic design, Cramer shoots with a designer's eye, which produces stunning images that are highly marketable. Thirty-Eighth Avenue Photography serves a diverse array of clients in wide variety of industries, including real estate, restaurant, floral, retail and others.

From commercial to fine art and portrait photography, Thirty-Eighth Avenue Photography enables clients to bring beauty and peace into their home or office, as well as promote their business. Along with the new studio address, Thirty-Eighth Avenue Photography has updated their website and offers site visitors the ability to view portfolio images online as well as purchase or license images. View the portfolio and gallery at www.38thavenuephotography.com.

Media Contact:
Steven V. Dubin, PR Works
This email address is being protected from spambots. You need JavaScript enabled to view it.
781-582-1061

Australia registered its new mandatory safety standard for toys containing magnets – Consumer Goods (Toys Containing Magnets) Safety Standard 2020 – on August 27, 2020.

This new instrument means toys containing magnets must conform to specific clauses within one of the following toy safety standards:

• AS/NZS ISO 8124.1:2019 ‘Safety of toys – Part 1: Safety aspects related to mechanical and physical properties’
• EN 71-1:2014+A1:2018 ‘Safety of toys – Part 1: Mechanical and physical properties’
• ISO 8124-1:2018 ‘Safety of Toys – Part 1: Safety aspects related to mechanical and physical properties’
• ASTM F963-17 ‘Standard consumer safety specification for toy safety’

Stakeholders should be aware the new instrument does not apply to bicycles, camping goods, electronic game units, fashion jewelry, home and public playground equipment, models powered by combustion or steam engines, sporting goods, and trampolines.

The new instrument came into effect on August 28, 2020. Manufacturers and suppliers of toys containing magnets have until August 28, 2021, to ensure their products comply with the requirements in the new legislation. Until this date, toys containing magnets may still comply with the current safety standard – Consumer Product Safety Standard for Children’s Toys Containing Magnets (Consumer Protection Notice No. 5 of 2010).

Children’s toys are regulated in Australia via multiple mandatory safety standards. These include:

• Consumer Protection Notice No. 14 of 2003, as amended by Consumer Protection No. 1 of 2005 ‘Toys for children up to and including 36 months of age’
• Consumer Protection Notice No. 1 of 2009 ‘Lead and certain elements’ (this standard includes finger paints)
• Consumer Protection Notice No. 5 of 2010 ‘Toys containing magnets’
• Consumer Goods (Aquatic Toys) Safety Standard 2020
• Consumer Goods (Projectile Toys) Safety Standard 2020

SGS Toy & Juvenile Product Services

SGS offers a wide range of services to ensure that products comply with relevant standards for toys and childcare articles and equipment. They provide consulting, training, product development, testing, audit, and inspection services to ensure that products comply with strict regulations worldwide, demonstrating the safety and quality of juvenile products being brought to the market.  Learn more about SGS’s Toy & Juvenile Product Services. 

SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full Australia Issues New Mandatory Standard for Toys Containing Magnets SafeGuardS. 

Subscribe here to receive SGS SafeGuardS direct to your inbox.

For further information contact:

Hingwo Tsang

Global Information and Innovation Manager

Tel:(+852) 2774 7420

Sanda Stefanovic
Toys expert
Tel: +31882144617

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Website: www.sgs.com/hardlines

LinkedIn: sgs-consumer-goods-&-retail

About SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.​

SGS, the world's leading inspection, verification, testing and certification company, will hold a free webinar on September 29, 2020, to discuss how to enter one of the largest retail and e-commerce markets in the world.

As the market shifts from key opinion leader (KOL) to key opinion consumer (KOC) influence in China, consumer engagement is becoming increasingly important. In this webinar, industry experts will share a number of country insights including how live streaming and short videos can help brands to successfully position their consumer facing products.

Why join this webinar?

To support your journey in entering this market, we will help you better understand the customer journey and other key dynamics, including:

• Digital marketing
• Customs and importation
• Compliance, and
• Consumer engagement

Who should join the webinar?

This webinar is aimed at brands, retailers and suppliers in the consumer goods industry looking to enter the Chinese market.

How can you register to join?

Register here for this free webinar on September 29, 2020 – choose from two sessions.

For further information on this webinar, please contact:

Christy Chan

Director, Consumer and Retail Solutions

Tel: +845 6018 6387
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Website: www.sgs.com/cgnr

LinkedIn: sgs-consumer-goods-&-retail

About SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

ENDS

For media inquiries, please contact:

Jackie Brown

PR Account Executive

Sugarloaf Marketing

T: +44 (0)1892 711240

M: +44 (0)779 297 0919

W: http://www.sugarloafmarketing.co.uk