Manufacturing Capabilities

Manufacturing Capacity:

Planned installed capacity 400 million gloves per month PHASE 1-part 1 

Project master plan – 4 phases for total planned capacity of 1.6 billion gloves per month

Initial products planned: 

• 4.0mil (4.2g) Ice Blue (optimized for healthcare)

• 5.0mil (5.5g) Blue, Black

• 5.5mil (5.9g) Blue, Black, Dark Green

• 6.0mil (6.5g) Orange      

Minimum Certifications Planned :

-The general safety and performance requirements of FDA Medical Device Regulation for Class 1 medical devices (21 CFR 880.6250) and complies with all general controls (section 513(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (Act); 21 U.S.C. 360c(a)(1)(A))

-The standard specification requirements for ASTM D6319- Freedom From Holes, Physical Dimensions Test, Physical Requirement Test and Packaging.

-The standard specification requirements for ASTM D5511 and D5526 – standard testing for anaerobic biodegradation.

-The standard specification requirements for ASTM D6978-05 - Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

-EEC regulations concerning the conformity of materials and products that are allowed to come into contact with food. In accordance with Regulation EEC 1935/2004, Regulation EC 10/2011 & Regulation (EC) No 2023/2006.

-The gloves are certified manufactured according to ISO 9001:2015 and ISO 13485:2016 Quality Management Systems.

-ESD rating (to comply with DHS/TSA guidelines), NFPA rating.

Optimized for Government, Healthcare, Dental, Industrial, Foodservice and Retail applications.

• Global impact

• Community of compassion

• Transparent operations

• Fulfilling journey