NEWS

Medical examination gloves are categorized by FDA as medical devices that need to pass stringent technical test before they can be labeled as safe for medical use. Gloves are intended for infection control, chemotherapy handling and are also preferred for non-medical applications that require a better-quality glove for enhanced protection.

All SW gloves meet or exceed recognized consensus standard for their applications jurisdictions. Testing conducted on our glove lines includes, but not limited to:

• Physical Properties (Tensile strength, water-tightness, elasticity, dimensions)
• Toxicity and Biocompatibility (as per ISO 10993)
• Viral Penetration (as per ASTM F1671)
• Chemotherapy Drug Penetration (as per ASTM D6978)
• Bioburden (as per ISO 11737-1)
• Biodegradability (as per ASTM D5526)
• Chemical Resistance (per ASTM F739)
• Mechanical Resistance (as per ANSI-ISEA 105)
• European equivalent standards (EN455, EN420, EN388, EN374)
• Food Safe Testing (21 CFR Part 177)

The Acceptable Quality Level (AQL) refers to a quality standard for measuring pinhole defects, the lower the AQL the less defects the gloves have. The pinhole leak test checks for barrier integrity and determine if glove is suitable for medical applications because a pinhole carries the risk for the user to be exposed to pathogens or micro-organisms.

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

SW is one of the pioneers in the medical gloves field with diverse and multiple 510K clearances in various materials. Our proven track record emphasizes our deep understanding of stringent FDA requirements, ASTM & ISO standards. Demonstrating SW’s glove manufacturing expertise, our product design and development meet or exceeds FDA standards, ensuring user safety and product performance efficiency.

If you want to sell medical devices in America, you need to obtain FDA approval for the device. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe, effective and equivalent to a legally marketed device.

Yes, SW has medical device licenses for powder free nitrile and latex examination gloves issued by Health Canada.

CE marking means that the product has been assessed by the manufacturer to meet the EU standards for safety and health. Gloves can fall under the medical device or personal protective regulations and must meet either or both requirements.

SW gloves are certified as Class I under EU MDR Regulation (EU) 2017/745 and Cat II & III Regulation (EU) 2016/425 on Personal Protective Equipment.

SW medical gloves will remain as Class I device under UK MDR 2002, we will also be compliant with the PPE regulation for our Cat II and III gloves as we are in the process of obtaining UKCA Certificate.

SW guarantees full compliance with all relevant (US and International) regulatory requirements and standards; we are adept in facilitating laboratory testing and readily acclimate to changes in the regulatory landscape. Our R&D and QA teams work together to identify and eliminate barriers to product quality, affording user access to high-quality gloves.

Yes, we do not use any ingredient or chemicals known to cause cancer, birth defects or other reproductive harm as listed on CA Prop 65.

Yes, SW gloves are safe to use in all parts of the food industry for food preparation and handling procedures. The USDA does not establish any official regulatory requirement for approval of gloves but follows the guidelines of the FDA’s specifications. Our gloves are safe for food and has been tested per FDA and EU standards.

Yes, SW gloves are tested against ASTM F1671 and ISO 16604 Determination of resistance of protective clothing materials to penetration by blood-borne pathogens. There will be an icon called EN374-5 with VIRUS written below. This means that the gloves have been tested and checked by a third party.

SW’s product portfolio meets the requirements set by OSHA Standard Numbers 29 Code of Federal Regulations (CFR) 1910.138 Hand Protection and 29 CFR 1910.1030 Bloodborne Pathogens. Our gloves provide mechanical, chemical and infection protection.

It refers to companies claiming that their products are environmentally friendly i.e. biodegradable, compostable, oxo-degradable, when often they are not. It is a form of false advertising with no evidences to support its claims.

Yes, we follow the FTC Green Guide by making a clear and qualified biodegradable claim on EcoTek® gloves. The biodegradation rate, test method and testing duration are displayed on the glove’s packaging for user’s reference.

The NFPA 1999-compliant gloves are medical examination gloves that are tested and certified to meet the criteria for Emergency Medical Services. SW’s UL NFPA certified nitrile and latex exam gloves passed a more rigorous barrier, puncture resistance and physical strength requirements established in this standard and are designed for high-risk applications.

SW gloves are verified as skin safe and accredited by Skin Health Alliance (SHA), a leading not-for-profit organization that awards professional dermatological accreditation. The assessment for accreditation is performed by a committee of scientists and dermatologist that thoroughly review the products’ ingredients, clinical trials data and proof of efficacy.

SW and its partner suppliers comply with social accountability audit and certifications such as SA 8000, Business Social Compliance Initiative (BSCI) and Sedex Members Ethical Trade Audit (SMETA). We have policies and procedures in place that protect and monitor health and safety of workers.

SW gloves holds a Silver Material Health Certificate (MHC) from Cradle to Cradle, that assures user that they are not exposed to carcinogens, mutagens or reproductive toxicants.

SW gloves are produced by ISO 9001 and 13485 certified facilities. FDA requires manufacturers to have a quality system to ensure a medical device is produce and tested for optimal use.

It is important to identify the key elements the user needs to perform their job safely, as different materials offer a resistance and protection to more than one hazard. Aside from that, there are other equally important factors that should help in choosing the right glove.

SW is encouraging safety and compliance officers to know their glove’s ABCDE– which stands for Allergy concern, Brand reliability & message, Comfort, Durability, EcoTek or environment friendly. We believe that taking this holistic approach is vital in keeping the wellbeing and safety of your team, safety and compliance officers should not sacrifice one for the other.