ASTM(American Society for Testing and Materials) certification is considered essential for medical products to be recognized in the United States. In particular, achieving Level 3, the highest level of certification, is a rigorous and demanding process. Only three Korean companies are known to have obtained Level 3 and one of them is Brade which also has obtained FDA approval for medical device. 

Certification from ASTM, approval from FDA

Brade started making protective clothing and medical gowns in 2020 and is expanding the scope to cosmetics and beauty shops overseas including US Federal Procurement market. It is notable that Brade’s medical gowns received ASTM’s Level 3. ASTM is a non-profit organization introducing standards on materials, products, systems and services and has 32,000 members and 100 government organizations and academic representatives. 

“Acquiring ASTM Level 3 for medical gowns is strict and demanding as it is the highest level. We want to publicize the excellence of our products through this acquisition.” says Brade CEO Seungju Shin.

With this achievement, Brade has received FAD approval for a medial device (510K) and signed a MOU with a U.S. Federal Procurement vendor to make an entry to the market. 

“This gives our medical gowns the same qualification as those made in the United States. The gowns are used by hospitals as a one-time consumable, not just during the pandemic, so we can have a stable revenue stream.” says Shin.

SHOWLAB

Brade was included in the President Yoon’s tour of Saudi Arabia, Qatar, Vietnam and the Netherlands last year. During the visit to Saudi Arabia, Brade signed an MOU with consumer goods manufacturer Gulf Care Factory to cooperate in the export and manufacturing of Korean cosmetics. SHOWLAB of Brade, in particular, is exosome-based cosmetics to be launched simultaneously in South Korea and Vietnam in cooperation with AMOVINO VIETNAM. The launching was made on suggestion of VTC marketing division head. SHOWLAB will start introducing an exosome collagen booster and then a skin care base. 

Products to be sold in the US, Europe and the Middle East.

Products of Brade is expected to be sold in the US, Europe and the Middle East while SHOWLAB and CELLNAR are scheduled to be sold as a shop-in-shop at a K-Beauty shop in Qatar. Brade’s flagship brands currently in progress include Korea’s CELLNAR and Nizimori Studio, and Chilean makeup brand ASIA, and Qatar KMC (Korea Medical Center). Brade strives to keep up with the rapidly changing times by constantly trying new things and looking at the market from different perspectives. 

“We look forward to continuing to revitalize the challenging apparel and cosmetics manufacturing market in the years to come.” says Shin.