Intended purpose of use: A single use garment, also known as an operating room (OR) gown, intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure in order to prevent transmission of infectious agents.
Technical specifications:
Non-woven, multilayer (SMS or SMMS).
Impervious supplementary protection layer (polyethylene film, nonwoven, etc.) in the critical zones (include the front of the body from top of shoulders to knees and the arms from the wrist cuff to above the elbow) = reinforced.
Breathable
For medium to high fluid level interventions.
Wraparound.
Long sleeves.
Cuffs made of elastic jersey.
Latex free.
Sterile, for single use.
Sizes available: Large, XLarge and XXLarge.
Length (shoulder seam to mid calf):
size Large: 140 cm (dimensions within 2% tolerance limits)
size XLarge: 150 cm (dimensions within 2% tolerance limits)
size XXLarge: 160 -170 cm
Shelf life 3-5 years
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or 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.
Note : For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year.
OR 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
Applicable standards (submissions to be made as per latest revisions):
• - EN 13795-1:2002: Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. General requirements for manufacturers, processors and products
- EN 13795-2:2004: Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. Test methods
- EN 13795-3:2006: Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. Performance requirements and performance levels
• AAMI PB70 for moderate risk and high risk situations
Intended use:
Strictly single use.
Non-woven gowns are intended for situations where sterilization is problematic.
Used in procedures where high level sterility is required.
Packaging and labelling:
One (1) unit with reverse folding in order to ensure an aseptic gowning technique.
Wrapped in a drape.
Double sterile packaging in peel-open pack.
Labelling on primary packaging (one unit) must include:
- Instruction for use in langauages English/ French/arabic/spanish or pictograms
- Name and/or trademark of the manufacturer
- Manufacturer address
- Manufacturer's product reference (product code)
- Type of product and main characteristics
- If the packaging is not transparent, it must bear a diagram showing the essential parts of the product
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol)
- Information for handling, if applicable (or equivalent harmonised symbol)
- Words ‘sterile with sterilization method, disposable, single use’
- Size
- Batch/lot and expiry date.
- CE mark with notified body number (+ EC REP), FDA, and equivalent
Secondary packaging: Packaging of multiple units
Labelling to be the same as primary packaging.
Extra information required: Number of units per box
Technical specifications:
Non-woven, multilayer (SMS or SMMS).
Impervious supplementary protection layer (polyethylene film, nonwoven, etc.) in the critical zones (include the front of the body from top of shoulders to knees and the arms from the wrist cuff to above the elbow) = reinforced.
Breathable
For medium to high fluid level interventions.
Wraparound.
Long sleeves.
Cuffs made of elastic jersey.
Latex free.
Sterile, for single use.
Sizes available: Large, XLarge and XXLarge.
Length (shoulder seam to mid calf):
size Large: 140 cm (dimensions within 2% tolerance limits)
size XLarge: 150 cm (dimensions within 2% tolerance limits)
size XXLarge: 160 -170 cm
Shelf life 3-5 years
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or 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.
Note : For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year.
OR 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
Applicable standards (submissions to be made as per latest revisions):
• - EN 13795-1:2002: Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. General requirements for manufacturers, processors and products
- EN 13795-2:2004: Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. Test methods
- EN 13795-3:2006: Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. Performance requirements and performance levels
• AAMI PB70 for moderate risk and high risk situations
Intended use:
Strictly single use.
Non-woven gowns are intended for situations where sterilization is problematic.
Used in procedures where high level sterility is required.
Packaging and labelling:
One (1) unit with reverse folding in order to ensure an aseptic gowning technique.
Wrapped in a drape.
Double sterile packaging in peel-open pack.
Labelling on primary packaging (one unit) must include:
- Instruction for use in langauages English/ French/arabic/spanish or pictograms
- Name and/or trademark of the manufacturer
- Manufacturer address
- Manufacturer's product reference (product code)
- Type of product and main characteristics
- If the packaging is not transparent, it must bear a diagram showing the essential parts of the product
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol)
- Information for handling, if applicable (or equivalent harmonised symbol)
- Words ‘sterile with sterilization method, disposable, single use’
- Size
- Batch/lot and expiry date.
- CE mark with notified body number (+ EC REP), FDA, and equivalent
Secondary packaging: Packaging of multiple units
Labelling to be the same as primary packaging.
Extra information required: Number of units per box
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $1.33 |
