IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected supplier.
Intended Use:
To prevent contamination of the hands when providing care for patients.
General Description:
Examination Gloves, nitrile, Powder Free, Large, disposable, box/100
Technical Specifications:
• Material: nitrile
• Powder free
• Non-sterile
• Single-use disposable
• Size: large (8.5 to 9.5)
• Fits either hand
• Thickness at fingertips of >= 120um
• Freedom from hole AQL 1.5
• Box of 100 gloves
• CE marked - Conform to EN-455 and EN 374
• Protection against dangerous chemicals and microorganism
Shelf life 3-5 years
Applicable standards (submissions to be made as per latest revisions):
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
of equivalent set of standards
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of For medical devices used as PPE, both PPE Regulation EU 2016/425 and EU 2017/745 (MDR) apply. For PPE, only the PPE Regulation EU 2016/425 (MDR) applies with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class I device
Labelling on the primary packaging:
- Instruction for use in languages English/ French/Arabic/Spanish of pictograms
Name and/of 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"" (of equivalent harmonised symbol) (if applicable).
Expiry date by year and month, prefixed by the word ""EXP"" (of equivalent harmonised symbol) (if
applicable).
The words ""for single use"" (of 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
(of equivalent harmonised symbol).
Manufacturer's instruction for use.
Alternatively, the instruction for use can be indicated on a separate insert.
These technical specifications are generic and may vary depending on the selected supplier.
Intended Use:
To prevent contamination of the hands when providing care for patients.
General Description:
Examination Gloves, nitrile, Powder Free, Large, disposable, box/100
Technical Specifications:
• Material: nitrile
• Powder free
• Non-sterile
• Single-use disposable
• Size: large (8.5 to 9.5)
• Fits either hand
• Thickness at fingertips of >= 120um
• Freedom from hole AQL 1.5
• Box of 100 gloves
• CE marked - Conform to EN-455 and EN 374
• Protection against dangerous chemicals and microorganism
Shelf life 3-5 years
Applicable standards (submissions to be made as per latest revisions):
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
of equivalent set of standards
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of For medical devices used as PPE, both PPE Regulation EU 2016/425 and EU 2017/745 (MDR) apply. For PPE, only the PPE Regulation EU 2016/425 (MDR) applies with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class I device
Labelling on the primary packaging:
- Instruction for use in languages English/ French/Arabic/Spanish of pictograms
Name and/of 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"" (of equivalent harmonised symbol) (if applicable).
Expiry date by year and month, prefixed by the word ""EXP"" (of equivalent harmonised symbol) (if
applicable).
The words ""for single use"" (of 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
(of equivalent harmonised symbol).
Manufacturer's instruction for use.
Alternatively, the instruction for use can be indicated on a separate insert.
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $3.88 |
