General Description:
Examination Gloves. Nitrile. Powder-free. Large. Disposable.
Technical Specifications:
Material: nitrile. Powder-free. Non-sterile. Single-use, disposable. Size: large (8.5 to 9.5). Fits either hand. Thickness at fingertips: ≥ 120 µm. Freedom from hole AQL 1.5. Box of 100 gloves. CE marked – Conforms to EN-455 and EN-374. Protection against dangerous chemicals and microorganisms. Shelf life: 3-5 years.
Applicable Standards:
EN 455-1. EN 455-2. EN 455-3. EN 455-4. EN ISO 374-1:2016 + A1:2018 – Protective gloves against dangerous chemicals and micro-organisms, terminology and performance requirements for chemical risks. EN ISO 374-2:2019 – Protective gloves against dangerous chemicals and micro-organisms, determination of resistance to penetration. EN ISO 374-4:2019 – Protective gloves against dangerous chemicals and micro-organisms, determination of resistance to degradation by chemicals. OR equivalent set of standards.
Regulatory and Conformity Requirements:
CE mark: Complies with EU Council Directive 93/42/EEC (MDD). For medical devices used as PPE: Both PPE Regulation EU 2016/425 and EU 2017/745 (MDR) apply. For PPE only: PPE Regulation EU 2016/425 (MDR) applies, with valid EC Certificate and Declaration of Conformity for the CE mark. CE certificate available for Class IIa and above devices. Manufacturer’s Quality Management System certified to ISO 13485:2016.
Classification:
Classified under EU MDR 2017/745 as a Class I device.
Labelling on the Primary Packaging:
Instructions for use in English/French/Arabic/Spanish or pictograms. Name and/or trademark of the manufacturer. Manufacturer's product reference. Type of product and main characteristics. If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the product in the packaging. Lot number prefixed by the word "LOT" (or equivalent harmonised symbol), if applicable. Expiry date by year and month, prefixed by the word "EXP" (or equivalent harmonised symbol), if applicable. The words "for single use" (or equivalent harmonised symbol). The words "destroy after use" (if space allows). Number of units per primary packaging, if applicable. Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol).
Manufacturer's Instructions for Use:
Alternatively, the instructions for use can be indicated on a separate insert.
Examination Gloves. Nitrile. Powder-free. Large. Disposable.
Technical Specifications:
Material: nitrile. Powder-free. Non-sterile. Single-use, disposable. Size: large (8.5 to 9.5). Fits either hand. Thickness at fingertips: ≥ 120 µm. Freedom from hole AQL 1.5. Box of 100 gloves. CE marked – Conforms to EN-455 and EN-374. Protection against dangerous chemicals and microorganisms. Shelf life: 3-5 years.
Applicable Standards:
EN 455-1. EN 455-2. EN 455-3. EN 455-4. EN ISO 374-1:2016 + A1:2018 – Protective gloves against dangerous chemicals and micro-organisms, terminology and performance requirements for chemical risks. EN ISO 374-2:2019 – Protective gloves against dangerous chemicals and micro-organisms, determination of resistance to penetration. EN ISO 374-4:2019 – Protective gloves against dangerous chemicals and micro-organisms, determination of resistance to degradation by chemicals. OR equivalent set of standards.
Regulatory and Conformity Requirements:
CE mark: Complies with EU Council Directive 93/42/EEC (MDD). For medical devices used as PPE: Both PPE Regulation EU 2016/425 and EU 2017/745 (MDR) apply. For PPE only: PPE Regulation EU 2016/425 (MDR) applies, with valid EC Certificate and Declaration of Conformity for the CE mark. CE certificate available for Class IIa and above devices. Manufacturer’s Quality Management System certified to ISO 13485:2016.
Classification:
Classified under EU MDR 2017/745 as a Class I device.
Labelling on the Primary Packaging:
Instructions for use in English/French/Arabic/Spanish or pictograms. Name and/or trademark of the manufacturer. Manufacturer's product reference. Type of product and main characteristics. If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the product in the packaging. Lot number prefixed by the word "LOT" (or equivalent harmonised symbol), if applicable. Expiry date by year and month, prefixed by the word "EXP" (or equivalent harmonised symbol), if applicable. The words "for single use" (or equivalent harmonised symbol). The words "destroy after use" (if space allows). Number of units per primary packaging, if applicable. Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol).
Manufacturer's Instructions for Use:
Alternatively, the instructions for use can be indicated on a separate insert.
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $3.88 |
