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Certifications & Instructions for Use
The compliance backbone of the range: CE certification under the PPE Regulation, the harmonised standards we test to, the quality system we manufacture under — and the IFUs that travel with every box.
CE Certification
PPE Regulation (EU) 2016/425 — Category III
RFB radiation protection gloves are CE‑marked as Category III personal protective equipment — the class reserved for protection against risks that can cause very serious consequences, including ionising radiation.
EN 61331‑1 / IEC 61331‑1 · ASTM F2547
The standards under which attenuation and lead‑equivalence of protective devices against diagnostic X‑radiation are determined and stated.
EN 421:2010
Protective gloves against ionising radiation and radioactive contamination — the glove‑specific PPE standard for this hazard class.
EN ISO 374‑1/‑5 · EN ISO 21420
Chemical and micro‑organism protection performance, plus the general requirements and test methods every protective glove must meet.
EN 455 series
Freedom from holes (AQL 0.65 at final inspection), physical properties and protein testing per EN 455‑3 using ASTM D5712.
Ethylene Oxide · SAL 10⁻⁶
Gloves are supplied sterile as inner‑wrapped pairs in sterile pouches, EO‑sterilised to a sterility assurance level of 10⁻⁶.
ISO 13485 & ISO 9001
Manufactured at our Noida SEZ facility in accordance with ISO 13485:2016 and ISO 9001:2015 quality management systems.
Instructions for Use
IFU library
Instructions for use covering intended purpose, indications, donning, warnings and disposal.
Compiling a tender or registration file?
We routinely support hospital tenders and national registrations with the documentation packs they require.