Since 1965, Busse Hospital Disposables has manufactured single-use medical devices and supplies for the healthcare industry from its U.S. facility. The Hauppauge company also designs custom procedural kits and trays and provides OEM manufacturing, packaging, sterilization, and regulatory support. Its medical-device manufacturing is FDA registered and ISO 13485 certified, while its affiliated Long Island Sterilization operation has served customers since 2001 in a 30,000-square-foot facility.
ISO 13485
FDA Registered Medical Device Manufacturer
Registration
ISO 11135
Compliance program
ISO 10993-7
Compliance program
AAMI Sterilization Standards
Compliance program
cGMP and FDA Guidelines
Compliance program
FDA
Quality certification
Propper Manufacturing Company, IncFamily-owned since its founding in 1945, Propper Manufacturing Company is a Long Island City medical-device maker known for helping healthcare professionals verify that sterilization processes have worked. Its U.S.-made products and biological monitoring service support clinical and non-clinical customers, while its OEM work adapts medical devices to the requirements of partner brands. Propper is ISO 13485:2016 certified and recently received FDA clearance for its EO Chex indicator tape.LONG ISLAND CITY, NY
Trinity Sterile, IncWith more than 70 years of sourcing and manufacturing experience, Trinity Sterile makes custom medical kits, surgical instruments, and phlebotomy tourniquets for healthcare providers across the United States. The company designs, assembles, and sterilizes its custom kits in-house, while also offering OEM and private-label manufacturing. Trinity Sterile is a certified Minority Business Enterprise and an ISO 13485:2016-certified medical-products facility.SALISBURY, MD
GMAX Industries, IncWith more than 30 years in the field, GMAX Industries makes and sources disposable medical supplies for patient care, operating rooms, and medical-device kit manufacturers. Headquartered in Hauppauge, the company combines global sourcing with manufacturing, private labeling, packaging, and kit assembly through locations in Virginia and China. GMAX is also a certified Minority Business Enterprise and operates under ISO 13485 and 21 CFR 820 quality requirements.HAUPPAUGE, NY
QosinaFounded in 1980 from entrepreneur Stuart Herskovitz’s guest bedroom, Qosina supplies OEM single-use medical device components to medical, pharmaceutical and biopharmaceutical companies. From its Ronkonkoma headquarters, the company offers more than 5,000 stock components, complimentary samples and product-development support for sourcing or adapting parts to a customer’s design. Its facility is certified to ISO 13485, ISO 9001, ISO 22301, ISO 45001 and ISO 14001 standards.RONKONKOMA, NY