Cleanroom Gloves
Cleanroom gloves that prevent particulate contamination are designed to meet stringent standards and the controlled environment requirements of pharmaceutical, medical device, and biotechnology manufacturers. They can be made of nitrile, natural rubber, PVC, rubber neoprene nitrile or polyurethane.
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FAQ
Cleanroom gloves are specialized gloves designed for use in controlled environments, such as cleanrooms, where contamination control is critical. These gloves are made from materials that minimize the release of particles and fibers. They are used in various industries, including pharmaceuticals, biotechnology, electronics, and aerospace, to protect both the products and the workers from contamination.
Key features of cleanroom gloves include Low Particulate Shedding, Sterility and Cleanroom Compatibility indicating cleanliness levels, such as ISO Class 3-5. Common materials are nitrile, latex, and vinyl. Nitrile gloves are particularly popular due to their resistance to chemicals and punctures.
The frequency of replacing gloves in a cleanroom depends on several factors:
- Task Changes: Replace gloves when switching tasks to prevent cross-contamination
- Visible Contamination: Replace immediately if gloves are contaminated or damaged
- Time-Based: In high-risk areas, change gloves periodically (e.g., every hour)
- Entering/Exiting: Change gloves each time a worker enters or exits the cleanroom
- Non-Cleanroom Contact: Replace gloves if they touch non-cleanroom surfaces
Category 3 gloves are a classification of personal protective equipment (PPE) under the EU's PPE Regulation (EU) 2016/42 and designed to provide protection against high-risk hazards, they are subject to rigorous testing and certification processes. Key features include:
- High-Risk Protection: For severe hazards like chemicals, extreme temperatures, or electrical risks
- Certification: Must pass independent testing by a notified body
- CE Marking: Includes a CE mark and a four-digit certification number
- Documentation: Manufacturers must provide detailed technical file and user instructions
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