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. 

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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.

Keeping up with continuous updates, DK business patron has commendably, once again, made it to the talked about topics in the industry. Launching a new outsourcing services division in the USA, the organization has marked it's a stronghold in the outsourcing service sector specifically in a nation like the USA now.

It has come to public knowledge that the overseas clients of DK business patron have been continually looking out for more from this outsourcing services giant and owing to the positive expectations and demand of its services, the organization decided to foray into the United States of America to establish an outsourcing division.

This move makes overseas client handling a piece of cake for the organization as now they will have first-hand access to their clients and will be able to cater to their needs in a better manner.

For quite a long time, DK business patron has been launching newer divisions of outsourcing services to meet the growing demands through the introduction of newer departments but launching an outsourcing division in the USA completely comes as an unexpected and path-breaking event for the organization.

As per reports, the managerial officials at DK business patron, intend to use the beneficialreasons for outsourcing to the USAas the flag bearer to promote their commendable services and diligent work overseas. The best part about the launch of this new division is that it not only focuses on foraying into a developed nation with outsourcing services but also that the organization has brought in a wide range of additional services that they will be providing specifically starting from there USA division. As an outsourcing company in the USA, DK business patron will be serving creative design, engineering services, mortgage services, software development services, web analytics, health care BPO, and transcription services as well.

In addition to these comparatively new offerings by this outsourcing giant, the basic Call center services, research, and analysis services, finance and accounting services and others will still be offered with fine updates to meet the current industry standards and to stand out with perfection.Additionally, the highly trained and learned team of DK business patron consists of professionals that despite the difference between core business process support and non core business process support handle the operations in the perfect manner using their expertise and years of work experience.

With the growing needs of organizations to cut on their operational costs to maximize profit and to utilize monetary resources in the best possible ways, outsourcing services is one such option that is gaining popularity with every passing day for the multiple benefits that outsourcing provides to any organization.

Taking into account the growing needs of organizations in terms of outsourcing services across the world and particularly in the United States of America, the organization realized that foraying into a different country would eventually bring additional clientele to them and enhance their business. DK business patron has always been in the news for recognizing the opportunities and working on them before anyone else which is also stated as one of the key reasons that make them stand apart in this industry as leaders.

Looking at the multiple reasons for OutsourcedBpo Services to USA and accounting for the commendable service profile that DK business patron has across the world, the new division in the USA is expected to create a mark for the organization in the international segment more prominently than it earlier did.

Experts have stated that with the emerging requirement of outsourcing solutions in the USA and the goodwill that DK business patron has already created by attending to all the requirements of their overseas client for a long period now are going to be the two major game-changing factors that will turn the odds in favor of DK business patron concerning the USA division and as a whole.

The competitors of this outsourcing giant have been put to silent hold as this move came quite unexpectedly and was a huge development to the organization. Concerning the developments that DK business patron has been making in the recent period, the market is continually eyeing the next development that they might launch themselves with.

“Face Everything and Rise” movement created by the Mexican producer Ariel Cervantes presents new “EP” album with 24 artists from 12 different countries to stand up against the COVID-19 impact.

New York, NY - USA | September 15, 2020 -- Face Everything and Rise is an international non-profit collective created in March, 2020 by the Mexican musician, composer and producer Ariel Cervantes, while getting stranded in New York City due to the worldwide lockdown (covid-19), in hopes to support and build connections between all kinds of artists from around the world and together create, collaborate and share our unique vision of the world.

The goal is to inspire through all sorts of art branches around the globe and motivate people to stand up and show how important and necessary art is to our daily lives, especially through the global pandemic of this year.

Along the way, Face Everything and Rise partnered up with the composer Oscar Mendez who created the “We are citizens of the world” movement and with a global music industry changing platform developed by the amazing team of great and visionary minds Veronica Vitale and Patrick Hamilton from Artist United and Visionary Vanguard; Who also seek to bring professional and enthusiastic music creators together from all over the world in a message of Peace and Universal Brotherhood.

Together, we gathered the talents of 24 artists from 12 countries around the world (USA, Mexico, United Kingdom, Philippines, France, Russia, Romania, Paraguay, Italy, Ghana, Biafra and Canada.) and produced 7 original songs in a multi-genre format to be released on September 11th, as a message of Hope, Love and Strength:

1. FEAR (Intro) (Liquid & Avant-garde Pop) Veronica Vitale, Patrick Hamilton, Xavier Ayhllón

2. Hymn to Humanity (Liquid & Avant-garde Pop) Veronica Vitale, feat. Signechor Vybez and Maobi N.

3. Bossamba (Popular Brazilian Music fused with Jazz arrangements) Ariel Cervantes

4. Electro-Tango (Fusion) Ariel Cervantes

5. On the Edge (Pop-Ballad) Ariel Cervantes

6. Standing as One (Alternative Rock) Ariel Cervantes

7. Java Suite Gamelan (Piano Suite) Leopold Godowsky / Fernando Ayhllón

8. We are citizens of the World (Pop) Oscar Méndez

Instagram: Face Everything and Rise

Press & Media Contact:
Ariel Cervantes
Face Everything and Rise
City of Mexico, Mexico
+14045197213
This email address is being protected from spambots. You need JavaScript enabled to view it.
https://www.instagram.com/faceeverythingandrise2020/

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