UNDERGLOVES SURGICAL, coloured, latex, s.u., ster., pair, 9

STD SMSUGLOSUL90

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
T01010102 - Non-powdered latex surgical gloves
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

SURGICAL UNDERGLOVES, coloured, latex, pair

Definition

Pair of sterile surgical gloves used to protect both patient and staff from infections transmitted through contact with the hands.

The under-glove is coloured which enables the immediate detection of perforation in the outer glove, of light colour

They are used to protect both the patient and the staff against contamination from microorganisms during a surgical intervention.

Specifications

Quality Standards Comment

Technical specifications

  • Natural latex, non powdered
  • Protection 45 min to 1 h minimum
  • Anatomically-shaped: 1 right hand and 1 left hand clearly identified in the packaging
  • Dimensions double pairs of surgical gloves
Size inner gloveMin. lengthWidth outer- inner handpalm
7275 mm85-91 ± 3 mm
7.5278 mm91-96 ± 4 mm
8288 mm95 ± 5 mm
8.5289 mm102 ± 6 mm
9290 mm108 ± 6 mm
  • Outer glove is a half size smaller than the inner glove because of:
    • a better comfort: the pressure is lowered when having a bigger under glove (inner)
    • a better adhesion gives a good visibility in case of perforation of the glove during the intervention
  • Thickness:
    • Finger: 0.19-0.24 mm
    • Palm : 0.19-0.27 mm
    • Cuff: 0.16-0.20 mm
  • Cuff with rolled edges
  • Coated inner surface (polymere, polyurethane, silicone, …)
  • Textured of micro-textured external surface
  • Coloured: green, blue ...
  • Sterile, for single use

Packaging & Labelling

Sterile packaging in peel-open pack, per pair

The gloves are presented in a field, the sleeves reversed up to the thumb to allow aseptic extraction, with identification of right hand and left hand.

The labelling must carry the following information:

  • "(product) containing natural rubber latex which may provoke allergic reactions, such as anaphylactic shock"
  • "non powdered glove"

Instructions for use

Some restricted information has been hidden. Sign in to see this information

Precautions for Use

  • SINGLE USE
  • Wash hands before and after use of gloves.
  • To be worn only on dry hands.
  • Discard defective or deteriorated gloves.
  • Remove and replace gloves which are damaged while in use.
  • Carefully follow undressing procedure when gloves are removed.
  • In case of allergy to latex, order latex-free gloves (see related articles).

Storage

  • Store below 30°C, Protect from sunlight ‐ Protect from humidity
  • In the original packaging

MSF requirements

  • Non powdered gloves, allowing the use of hydroalcoholic solution as hand cleanser
  • Gloves to wear under a pair of regular surgical gloves: the coloured inner gloves enables an immediate detection of the perforations.
Some restricted information has been hidden. Sign in to see this information