Packaging Symbols

Authorized Representative in the European Community

ISO 15223-1

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Batch Code

ISO 15223-1:2012

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Date of Manufacture

ISO 15223-1:2012

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Use by Date

ISO 15223-1:2012

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Catalog Number

ISO 15223-1:2012

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Caution, Consult Accompanying Documents

ISO 15223-1:2012

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Do Not Reuse

ISO 15223-1:2012

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Non Latex

ISO 15223-1:2012 (Annex B, 15223-1:2012)

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Product Containing Natural Rubber Latex

ISO 15223-1:2012

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Non Sterile

ISO 15223-1:2012

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Recyclable Cardboard

Recyclable Paperboard

Keep Away from Rain

ISO 15223-1:2012

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Keep Away from Sunlight

ISO 15223-1:2012

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Temperature Limitation

ISO 15223-1:2012

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Tested for Use With Chemotherapy Drugs

ASTM F739 & ASTM D6978

Symbol used for SW chemotherapy tested gloves that have been tested either by ASTM F739 or by ASTM D6978.

Tested for Use With Fentanyl & Simulated Gastric Acid

ASTM D6978-05 (2019)

Symbol used for SW fentanyl & simulated gastric acid tested gloves that have been tested by ASTM D6978-05 (2019).

Skin Health Alliance

SHA Approved

The Skin Health Alliance award professional accreditation and endorsement to companies, services and brands seeking specialist independent dermatological recognition for their product research.

British Safety Industrial Federation

BSIF Registered Safety Supplier

The United Kingdom's leading trade body within the safety industry.

REACH Compliant

REACH Compliant

REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry.

Eurasian Conformity Mark

TR CU 019/2011

Safety Personal Protection Equipment

UL Mark

UL NFPA 1999

Standard on Protective Clothing and Ensembles for Emergency Medical Operations

Consult Instruction for Use

ISO 15223-1:2012

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

Safe for Food Contact

EU 1935/2004

Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food

ANSI CUT HAZARD PROTECTION

American National Standard For Hand Protection Classification

ANSI/ISEA 105-2016 addresses the classification and testing of hand protection for specific performance properties related to chemical and industrial applications.

ANSI ABRASION HAZARD PROTECTION

American National Standard For Hand Protection Classification

ANSI/ISEA 105-2016 addresses the classification and testing of hand protection for specific performance properties related to chemical and industrial applications.

ANSI PUNCTURE HAZARD PROTECTION

American National Standard For Hand Protection Classification

ANSI/ISEA 105-2016 addresses the classification and testing of hand protection for specific performance properties related to chemical and industrial applications.

ANSI IMPACT HAZARD PROTECTION

ANSI/ISEA 138-2019: American National Standard For Performance And Classification For Impact-Resistant Gloves

EN ISO 374-1:2016

Type A

Protective gloves against dangerous chemicals and micro-organisms

The chemicals break through the glove material at a molecular level. The breakthrough time is here evaluated and the glove must withstand a breakthrough time of at least: Type A – 30 minutes (level 2) against minimum 6 test chemicals

EN ISO 374-1:2016

Type B

Protective gloves against dangerous chemicals and micro-organisms

The chemicals break through the glove material at a molecular level. The breakthrough time is here evaluated and the glove must withstand a breakthrough time of at least: Type B – 30 minutes (level 2) against minimum 3 test chemicals

EN ISO 374-1:2016

Type C

Protective gloves against dangerous chemicals and micro-organisms

The chemicals break through the glove material at a molecular level. The breakthrough time is here evaluated and the glove must withstand a breakthrough time of at least: Type C – 10 minutes (level 1) against minimum 1 test chemical

MICRO-ORGANISMS HAZARDS

Protective gloves against dangerous chemicals and micro-organisms — Part 5: Terminology and performance requirements for micro-organisms risks

EN 374-5:2016

All gloves must be tested against micro-organisms. The gloves are tested to protect against bacteria and fungi, but also viruses if requested, according to EN 374-5:2016.

MICRO-ORGANISMS & VIRUS HAZARDS

Protective gloves against dangerous chemicals and micro-organisms — Part 5: Terminology and performance requirements for micro-organisms risks

EN 374-5:2016

All gloves must be tested against micro-organisms. The gloves are tested to protect against bacteria and fungi, but also viruses if requested, according to EN 374-5:2016.

MECHANICAL HAZARDS

EN 388:2016+A1:2018

Protective gloves. General requirements and test methods

ELECTRO STATIC TEST STANDARD

EN 16350:2016

Prescribes test conditions and minimum requirements for the electrostatic properties of protective gloves

Cold Hazard Test Standard

EN511:2016

Measure how well the glove can withstand both convective cold and contact cold

CE Mark

(made in compliance with Regulation (EU) 2016/425, Category III MODULE C2)

Regulation (EU) 2016/425

Personal Protective Equipment Directive. Notified Body ID is 0493.

CE Mark

Regulation (EU) 2016/425

Personal Protective Equipment Directive. Notified Body ID is 0598.

CE Mark

(made in compliance with 93/42/EEC)

Medical Device Regulation (MDR) (2017/745)

Medical Device Regulation (MDR) (2017/745). Medical Device Directive.

CE Mark

UKCA Mark

The UKCA (UK Conformity Assessed) marking is a new UK product marking that is used for goods being placed on the market in Great Britain (England, Wales and Scotland).