sempermed® derma plus

PRODUCED SAFETY: A lightly powdered, latex surgical glove produced in a specially developed double-dipping process, thus offering high tear resistance and reliable impermeability. Additonally, the glove has good grip due to its micro-rough surface texture.

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Description

Manufactured while using the specially developed double-dipping process the sempermed® derma plus excels with good donning properties and anatomically perfect shape.

Our surgical glove artwork has changed recently. Please find all information on the changes here​​​​​​​. 

Benefits

  • MANUFACTURED WITH SAFETY IN MIND
    High tear resistance and reliable impermeability through double-immersion production process.
     
  • A RELIABLE GRIP
    Good grip through micro-rough surface texture, even in a moist environment.
     
  • COMFORTABLE TO WEAR
    Fully anatomically shaped with broader and more comfortable back of the hand and naturally curved fingers.

Downloads

sempermed® derma plus datasheet
Sempermed Surgical Glove Portfolio

Specifications

Type

Sterile surgical glove for single use, lightly powdered

Material

Natural Rubber (NR) 

Internal finish

Lightly powdered with natural cornstarch

Glove surface

Micro-rough

Colour

Natural white

Glove Shape

Fully anatomical with curved fingers and rolled rim

Size

Overall length as per EN 455-2
5 ½                      min. 270 mm
6 and 6 ½            min. 270 mm
7, 7½ and 8         min. 280 mm
8 ½ and 9            min. 285 mm

Wall thickness

Measured in single layer in the palm area
0.22 +/- 0.03 mm

Barrier performance

Tightness as per EN 455-1
AQL 0.65 

Force at break

exceeding EN 455-2
median ≥ 12 Newton 

Shelf Life

in original packaging if stored according to product specification
5 years

Sterilisation

Irradiation

Labeling & CONFORMITY TO STANDARDS

EN 1041, EN 455, EN 421, EN 374, EN 16523, EN ISO 21420, ISO 15223

Packaging

Left and right glove with turned up cuff in inner pouch, ozone-tight, sealed in medical peel pack.
In dispenser carton with sterilisation indicator: 50 pairs
In transport carton with sterilisation indicator: 300 pairs

INTENDED PURPOSE

Surgical gloves are intended to be worn by healthcare professionals to protect a surgical wound from contamination. The devices are single-use and intended to be used in a sterile condition.

  • Medical device class IIa as set out in MD Directive 93/42/EEC
  • Single use protective glove – PPE category III (protection against chemical substances for limited time*) as set out in PPE Regulation (EU) 2016/425

 

LIMITATIONS, CONTRA-INDICATIONS, PRECAUTIONS, WARNINGS


Warning: This product contains natural latex which may cause allergic reactions, including anaphylactic shock.These products should not be used when latex allergy is known.
Warning: This product contains powder which can promote skin damage, irritation,  absorbtion and transport of allergens, endotoxins and pathogens which could lead to infections.


For further information please also see:

www.sempermed.com/fileadmin/user_upload/MediaLibrary/Sempermed/Switch_to_PowderFree_Gloves.pdf

Warning: This product contains accelerators of Dithiocarbamate types. These products should not be used if hypersensitivity of these substances exits.
For further information, a list of substances contained in the glove is available upon request.

*Please note that all Sempermed products must be used in accordance with the Sempermed chemical resistance and the respective declaration of conformity.

Failure to observe this information, in particular with regard to chemical resistance, frequency of use and tolerability of the gloves, can result in personal injury and/or material damage. Sempermed is not liable for incorrect use of the gloves nor will Sempermed be liable for improper storage and handling. In case of indications of damage or unusual signs of wear and tear to the gloves, the gloves should not be used. In case of any doubt, expert advice should be sought before use. This information and classification is up to date as of the date of the last update to this page. Technical details are average values from production and may vary in individual cases. This disclaimer is subject to mistakes, printing errors and amendments.

 

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