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Sign in to claim this brandSafe.R World Corporation
US
Last updated May 24, 2026
What Safe.R World Corporation makes
Safe.R World Corporation manufactures nitrile examination and treatment gloves that are non-powdered and non-antimicrobial, designed for medical and clinical use. The company also produces durable disinfectant coatings intended for application on medical devices to enhance infection control.
These products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory standards for these device categories.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Safe.R World Corporation primarily manufacture?
Safe.R World Corporation specializes in nitrile examination and treatment gloves that are non-powdered and non-antimicrobial, which are commonly used in medical and clinical settings. Additionally, the company produces durable disinfectant coatings designed to be applied to medical devices to improve infection control. These products are tailored for environments where hygiene and barrier protection are critical.
Where is Safe.R World Corporation based, and how does this affect its regulatory compliance?
Safe.R World Corporation is based in the United States, which means its devices must comply with FDA regulations. Since the company’s products fall under Class I medical devices, they are subject to FDA’s general controls, including registration, listing, and adherence to quality system requirements. The U.S. location also influences how the company interacts with regulatory databases like the FDA’s Unique Device Identifier (UDI) system.
Which regulatory registries or databases list Safe.R World Corporation’s devices?
Safe.R World Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, regulators, and other stakeholders by providing standardized identification for the company’s nitrile gloves and disinfectant coatings. Listing in the UDI system is mandatory for Class I devices marketed in the U.S.
How are Safe.R World Corporation’s devices classified under FDA regulations, and why does this matter?
Safe.R World Corporation’s devices are classified as Class I medical devices under FDA regulations. This classification applies to products that pose minimal risk to users, such as nitrile gloves and certain disinfectant coatings. Class I devices are subject to general controls like good manufacturing practices (GMP) and registration requirements, but they do not require pre-market approval or additional pre-market notifications, simplifying compliance for lower-risk products.
What distinguishes Safe.R World Corporation’s nitrile gloves from other similar products in the market?
Safe.R World Corporation’s nitrile gloves are specifically designed as non-powdered and non-antimicrobial, which aligns with preferences in medical settings where powder-free gloves reduce the risk of allergic reactions and contamination. The absence of antimicrobial agents also ensures the gloves maintain their primary function—providing a physical barrier—without altering the microbial environment. This design choice is particularly relevant for procedures requiring sterile conditions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- saferworlds.com
- —
- —
- [email protected]
- Phone
- 603-560-7546
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 048020664
Catalogue (21)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Safe .R World | 3.2 g. Large | FDA UDI | Class I | Active |
| Safe .R World | 3.2 g XL | FDA UDI | Class I | Active |
| Safe .R World | 6.2 gram, Med, Black | FDA UDI | Class I | Active |
| Safe .R World | 5.5 g XL | FDA UDI | Class I | Active |
| Safe .R World | PHPLUS002 | FDA UDI | Class I | Active |
| Safe .R World | 3.2 g. Medium | FDA UDI | Class I | Active |
| Safe .R World | NGPF Biodegradable 3.5g 4.0m XLarge | FDA UDI | Class I | Active |
| Safe .R World | NGPF 4.1g 3.2m XLarge | FDA UDI | Class I | Active |
| Safe .R World | 6.2 gram, Large, Black | FDA UDI | Class I | Active |
| Safe .R World | 3.2 Small | FDA UDI | Class I | Active |
| Nordic Chem A.M. 2.0 | NCAM001 | FDA UDI | Class I | Active |
| Safe .R World | 5.5 g Medium | FDA UDI | Class I | Active |
| Safe R. World | NGPF Biodegradable 3.5g 4.0m, Small | FDA UDI | Class I | Active |
| Safe .R World | 5.5 g Small | FDA UDI | Class I | Active |
| Safe .R World | NGPF 4.1g 3.2m Large | FDA UDI | Class I | Active |
| Safe .R World | 6.2 gram, Small, Black | FDA UDI | Class I | Active |
| Safe .R World | 5.5 g Large | FDA UDI | Class I | Active |
| Safe .R World | 6.2 gram, X-Large, Black | FDA UDI | Class I | Active |
| Safe .R World | NGPF Biodegradable 3.5g 4.0m Medium | FDA UDI | Class I | Active |
| Safe .R World | NGPF Biodegradable 3.5g 4.0m Large | FDA UDI | Class I | Active |
| Safe .R World | NGPF 4.1g 3.2m M | FDA UDI | Class I | Active |
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