Sterile Powder-Free Latex Surgical Gloves - 50 Pairs

These sterile disposable powder-free gloves are designed for use by medical staff in the operating room, providing an effective barrier against the transmission of microorganisms between the operator and the patient. This minimizes the risk of cross-contamination, ensuring maximum safety for both healthcare staff and patients.

- Material: 100% high-quality natural rubber latex
- Color: White and cream
- Cuff: Rolled up for better grip
- Inner Surface: Polymer coating for ease of wearing
- Outer Surface: Smooth with micro-texture over the entire gripping area for safe handling of instruments
- Dust: None (no powder)
- AQL: 0.65 (Acceptable Quality Level)
- Sterilization: Sterilized by radiation
- Sizes Available: From 5.5 to 9.0
- Packing: 50 pairs per pack
- Disposable: Yes

Advantages:
- High Flexibility and Durability: The high-quality natural latex ensures that the gloves are both durable and flexible, adapting perfectly to the hand.
- Ergonomic Comfort: The ergonomic shape ensures comfort even during long-lasting surgical procedures.
- Secure Grip: The micro-texture on the outer surface provides a firm grip on surgical instruments.
- Chemical Protection: Provides protection against the penetration of hazardous chemicals, increasing safety when handling cytotoxic drugs and other harmful substances.
- Optimized Packaging: The packaging is designed to ensure easy access and optimal storage of the gloves, while maintaining high standards of hygiene.

Applications:
- General Surgery: Ideal for all surgical procedures that require sterile conditions.
- Specialized Procedures: Suitable for specialized surgeries that require high safety standards.
- Hospital Environment: Perfect for use in operating rooms, clinics, and other healthcare environments.

Packaging and Storage:
- Versatile Dispenser: Can be opened both vertically and horizontally, adapting to any space.
- Operational Efficiency: An additional opening for the return of unopened pairs of gloves saves time and increases staff efficiency.
- Reduced environmental impact: Compact packaging reduces the space required for the storage and use of cardboard, contributing to the reduction of waste and environmental impact.

The gloves meet the following international standards and regulations, ensuring quality and safety:

European Standards (EN):
- EN 455-1:2020+A1:2022: Requirements and tests for the evaluation of the absence of holes in medical gloves.
- EN 455-2:2015: Requirements and tests for the determination of physical properties (such as strength) of medical gloves.
- EN 455-3:2015: Biological evaluation and requirements for the evaluation of biocompatibility of medical gloves.
- EN 455-4:2009: Requirements related to the durability and storage of medical gloves, including degradation tests.
- EN ISO 374-1:2016+A1:2018: Requirements for protective gloves against hazardous chemicals.
- EN ISO 374-2:2019: Test methods for the penetration resistance of gloves against chemicals and microorganisms.
- EN 16523-1:2015+A1:2018: Determination of the resistance of materials to chemical permeation.
- EN ISO 374-4:2019: Determination of the degradation resistance of chemical protective gloves.
- EN 556: Requirements for sterile products to be labeled as "sterile".
- EN ISO 374-5:2016: Protective gloves against microorganisms (viruses, bacteria and fungi).
- EN ISO 21420:2020: General requirements for protective gloves, including ergonomics and marking.
- EN ISO 10993-1:2020: Biological evaluation of medical devices, risk management.
- EN ISO 10993-4:2017: Evaluation of blood interaction of medical devices.
- EN ISO 10993-5:2009: Evaluation of cytotoxicity of medical devices.
- EN ISO 10993-10:2023: Irritation and sensitization test of medical devices.
- EN ISO 10993-11:2018: Evaluation of systemic toxicity.
- EN ISO 10993-12:2021: Preparation of samples and reference materials.
- EN ISO 10993-18:2020/A1:2023: Chemical characterization of medical device materials.
- EN ISO 10993-23:2021: In vitro skin irritation test.
- EN ISO 11607-1:2020: Requirements for the packaging of sterilized medical devices.
- EN ISO 11607-2:2020: Validation of the sealing process of sterilized medical devices.
- EN ISO 11737-1:2018+A1:2021: Determination of bioburden on medical devices.
- EN ISO 11135:2014: Sterilization of medical devices with ethylene oxide.
- EN ISO 11137-1:2015: Radiation sterilization (definition of requirements).
- EN ISO 11137-2:2015+A1:2023: Validation of the radiation sterilization process.
- EN ISO 11137-3:2017: Guidance on the verification of radiation sterilization.
- EN ISO 14971:2019+A11:2021: Risk management for medical devices.
- EN ISO 15223-1:2022: Symbols for the labeling of medical devices.
- EN ISO 20417:2021: Requirements for the provision of information for the use of medical devices.
- EN 62366-1:2015+A1:2020: Usability of medical devices for patient safety.

International Standards (ISO):
- ISO 10282:2023: Disposable sterile surgical gloves, requirements and tests.
- ISO 2859-1:1999/Amd 1:2011: Sampling procedures for inspection by attributes (batch acceptance).

ASTM Standard:
- ASTM D5712: Test for the detection of latex proteins in gloves.
- ASTM D5151: Test for the detection of holes in gloves.
- ASTM D7160: Test for Chemical Compatibility of Medical Examination Gloves.
- ASTM D3577: Standard Specification for Rubber Surgical Gloves.
- ASTM D6978: Test for permeation of chemotherapeutic agents through gloves.
- ASTM F167: Standard for Evaluation of Resistance to Bacterial Penetration.

Quality Management Systems:
Production in accordance with EN ISO 9001, EN ISO 13485 and EN ISO 14001.

Classification:
- Class IIa medical device compliant with Directive 93/42/EEC (MDD)
- Category III Personal Protective Equipment according to PPE Regulation (EU) 2016/425