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ISO 13485 & CE Certification for Surgical Gloves

#1
Hi, Guys
I have recently joined a Startup Company as a Manager Regulatory Affairs & Quality. Company manufacturer Surgical Gloves (Sterile or Non-sterile). They want ISO 13485 & CE certification. But before they require Cleanroom for their product. I just want to know that what are the Clean Room Requirements for manufacturing and packaging Surgical Gloves? Please help me?
 
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