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EUDAMED last updated this device on Oct 9, 2025
88591306NO02VRFLEXCEL Pro Blue Nitrile Gloves Powder Free is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Sri Trang Gloves (Thailand) Public Company Limited. Placed on the EU market in Northern Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08859130658498GL288L1 packaging level registered — each level carries its own UDI-DI.
08859130658498× 100 unitsBase unit18859130658495× 10 units(01)08859130658498
European Medical Device Nomenclature — the EU product classification assigned to this device.
T01020204NITRILE EXAMINATION / TREATMENT GLOVES1 warning recorded — scroll inside the panel to see all entries.
Contains Dithiocarbamates which could lead to allergic reaction - do not use, if sensitized.
TH-MF-000010448The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in XI; available across 1 country total.
Placed on the market in XI; per-country availability dates not published.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
G15 099188 0014IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
88591306NO02VROn the marketFLEXCEL Pro Blue Nitrile Gloves Powder Free88591306NO02VROn the marketFLEXCEL Pro Blue Nitrile Gloves Powder Free88591306NO02VROn the marketHOZ88591306NO02VROn the marketHOZ88591306NO02VROn the marketHOZ88591306NO02VROn the marketNo certificate specifically references this device's Basic UDI-DI.