“The customized swab, and more importantly, the team at Puritan who worked with us—starting with our rep—provided us with the perfect sampling tool. And, we’re excited to see the results of this research using this swab.”
— Emily Curd, Research Associate, University of California

Credentials

All of our products come backed with the Puritan promise of quality. Our manufacturing facility is ISO certified and CE mark registered so you can be certain we always adhere to the strictest quality guidelines. Every product that we make is the very best of its kind.

Credentials

ISO 9001:2008 Registered
ISO 13485:2003 Medical Device Regulations
CE Mark Certified
PAL Accreditation No. BG30400220
FDA Registration
Our Customers
Environmental Partnerships

ISO 9001:2008 Registered

To achieve ISO 9001:2008 certification by the International Organization for Standardization — a worldwide governing body — a company must demonstrate that it has an effective quality assurance system that satisfies all the required applicable industry standards. An external auditor, or registrar, conducts an onsite audit of the company’s manufacturing processes to determine if it is in compliance with that industry’s best practices.

Puritan is ISO 9001:2008 registered, and all production comes under the most stringent quality controls. PDF

FM 31363 ISO Certification

ISO 13485:2003 Medical Device Regulations

ISO 13485 is the ISO 9000 for medical device manufacturers. Embracing the FDA’s good manufacturing practices, this standard defines terms such as medical device, active medical device, active implanted medical device, sterile medical device, and more.

This international standard specifies requirements for a quality-management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. PDF

FM 75992 13485 Certification

CE Mark Certified

It is accurate to state that our medical products carry the CE mark; CE mark refers to product compliance rather than facility or quality system compliance. BSI certifies the sterility of the medical device line, and Puritan self declares CE compliance of the non-sterile line of medical devices. PDF

CE Mark Certification

PAL Accreditation No. BG30400220

It is accurate to state that we are registered with the Japan’s Minister of Health, Labour and Welfare (MHLW), an organization equivalent to the U.S. Food and Drug Administration, and comply with the PAL regulations. Regulatory agencies do not “approve” devices or drugs or manufacturers.

FDA Registered

Puritan brand products are manufactured under FDA requirements for medical devices. Our Quality Systems conform to the Food and Drug Administration’s Good Manufacturing Practices (GMPs).

Our quality control procedures include verification and documentation of raw materials and machine settings and visual examinations of finished goods for correct raw materials, labels, packaging, dimensions, contamination, and tip adhesion. Results are documented, and records are maintained for five years. FDA Registration

Our Customers

Leading national medical distributors, whose products are found in hospitals, emergency rooms, and treatment rooms across the country, partner with us for their many private-label products. As a medical products company we manufacture proprietary applicators and provide specially packaged first aid supplies and promotional products for the major diagnostic and pharmaceutical companies in the U.S. and abroad.

Environmental Partnerships

Puritan and its suppliers support responsible forestry practices and are signatories to certification programs such as The Sustainable Forestry Initiative and the Chain of Custody program. We value our country’s environmental heritage and are committed to doing our part to assure that our forests, lakes, and streams are here for the enjoyment of generations to come.

Competitive Research Study shows Puritan’s foam swabs provide superior influenza detection. A recent study conducted by Nationwide Children's Hospital in Columbus, Ohio has concluded that Puritan's foam swabs outperform flocked swabs for detecting influenza.