IMPORTANT: These specifications are generic and may vary depending on the selected supplier.
Intended use: protection for head from contamination by infectious agents during surgical procedure
Description: A non-sterile cap to completely cover the hair and is intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is an elasticated cap that is universal size for adults.
Technical specifications
Material : non-woven (polypropylene)
One size (Ø 53 - 60 cm)
Size and design shall accommodate and completely cover all hair types
Elastic: latex-free elastic
Lightweight 10 to 30g
Impervious to liquid and non absorbent
Breathable
Non-sterile, for single use
Shelf life 3-5 years
shall be clean with bioburden less than 30 cfu/g
Free from loose particles and fibbers.
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
Packaging and labelling: manufacturer name address, mfg. date and expiry
Instructions for use in English/Arabic, Spanish and French of pictograms
Intended use: protection for head from contamination by infectious agents during surgical procedure
Description: A non-sterile cap to completely cover the hair and is intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is an elasticated cap that is universal size for adults.
Technical specifications
Material : non-woven (polypropylene)
One size (Ø 53 - 60 cm)
Size and design shall accommodate and completely cover all hair types
Elastic: latex-free elastic
Lightweight 10 to 30g
Impervious to liquid and non absorbent
Breathable
Non-sterile, for single use
Shelf life 3-5 years
shall be clean with bioburden less than 30 cfu/g
Free from loose particles and fibbers.
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
Packaging and labelling: manufacturer name address, mfg. date and expiry
Instructions for use in English/Arabic, Spanish and French of pictograms
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $3.14 |
| Pack of 500 | $19.50 |
