Knowledge
KINGFA Solutions
Hand Protection
Respiratory Protection
Environmental Solutions
Industrial Protection
Filtering Material
Protective Apparels
Laboratory Solutions
Email：
kingfamed@kingfa.com
Address：
No.33 Kefeng Road, Science City, Guangzhou, Guangdong Province, China, 510663
INQUIRY
How to Select Hand Protection Equipment?
Cleanroom Gloves: Processes & Application
KINGFA Biodegradable Solution
FDA Approved
classification
EN
CE Certificate
ISO
en 374
KINGFA，Biodegradable nitrile gloves
latex-free gloves
medical gloves
Accelerator-free nitrile gloves，Hypoallergenic，super-soft
FIME 2025
KINGFA Face Masks
EU Medical Mask Standards
FFP2 Mask
Meltblown Fabric
Chemical-resistant nitrile gloves
Industrial hand protection
Agriculture，Laboratory
Chemical-Resistant Nitrile Gloves
Choose Respiratory Protective Equipment
Kingfa Medical Laboratory Consumable
Advancing Safety: Black Nitrile Gloves
Nitrile Gloves
Knowledge
Regulatory Access Systems for Nitrile Gloves in Major Global Markets — FDA and CE Market Access & Compliance Practices
This article analyzes FDA (510(k)) and CE (MDR/PPE) regulatory requirements for nitrile gloves in the U.S. and EU markets, covering classification, testing standards (ASTM/EN), and compliance strategies. It provides guidance for manufacturers navigating global certifications.
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