TECHNICAL DATA SHEET

DISPOSABLE STANDARD SURGICAL GOWN

1. FABRIC DATASHEET

Nonwoven Material which are used in the production of this special type of standard surgical gown.

Fabric RawMaterial Color Weight Properties

Medical Nonwoven

Fabric PP SMMS fabric

Medical Blue

SMMS 43 gsm (+/-2 gsm)

Antistatic

Opaque Soft Touché

Hydrophobic Hyghly Breathable

Metal Free

Impermeable to Microbial Migration OEKO-TEX Certified ISO 9001 Anti-Allergenic

All our fabrics are metal free and do not contain any radioactive elements neither biological

products. All our Fabrics are certified by Oeko-tex Standard 100 and manufactured under strict ISO

9001 guidance.

2. STANDARD SURGICAL GOWN FEATURES

2.1. PRODUCTS DESCRIPTION

Our Sterile Standard Surgical Gown are made to provide high thermal comfort, high flexibility to the

operator. They are made of a hydrophobic soft touché nonwoven material with weight min. 40 g/m2

SMMS . Our Standard Surgical Gown has a resistance to liquid penetration of at least 52 cm of H20

according to NWSP 080.6.R0(15) Test Method (Hydrostatic Head). The Fabric used to manufacture

the gown has a thickness of 0.33 mm NWSP 120.1.R0 (15).

Our Sterile Standard Gowns are folded in a Pasteur Folding way to ensure aseptic application, and

keep the sterile and non sterile area separated during application,tied to internal and external traces

with a cardboard box, at the back, near the neck, a Velcro fastening system, elastic and comfortable

cuffs with a length of min. 8,00 cm, made of polyester and anti - frayed, seams made of ultrasonic

welding technique.

Our Standard Surgical Gowns have individual size marking in the form of a sticker affixed to the

gown, allowing identification before unfolding.

2.2. INTENDED USE

This standard surgical gown is intended to be used to protect healthcare professional during surgical

procedure and to provide to the user an absolute confort in the usage. It is mostly intended for the

surgeons and practical nurses. With its hydrophobic property the standard surgical gown is design to

whistand every liquid from one side to the other and ease the movement of the surgeon during

operation. They are mostly use in standard and short duration surgical operation (ophtalmic surgery

procedure, …).

2.3. CATEGORY

The standard surgical gown can be classify in the sterile category.

2.4. QUALITY ASSURRANCE

Our Standard Surgical Gown is manufactured in accordance with the EN ISO 13485 standard. This

ensures that we deliver products and services that consistently meet customer requirements,

guaranteeing full customer satisfaction.

All our products have a CE label and comply with the requirements of the Medical Device Directive

93/42/EEC.

Our Standard Surugical Gown are manufactured with Fabrics that are manufactured under

Oekotex and ISO 9001 quality guidelines.

2.5. SKIN IRRITATION TEST

Skin Irritation Scoring Table

SMMS Fabric Irritation Test Results

2.6. DIMENSION

STANDARD SURGICAL GOWN TABLE SIZE

TOLERANCE

S M L XL XXL

A 120 125 130 135 140 ±2

B 111.5 115.5 120.5 120 129.5 ±2

C 70 74 77 80.5 84 ±2

D 10 10 10 10 10 ±2

E 145 150 155 160 165 ±2

F 5 5 5 5 5 ±2

G 13.5 14,5 15,5 16.5 17.5 ±2

H 66 68 70 73 76 ±2

I 4 4 4 4 4 ±2

J 16 17 18 19 20 ±2

K 46 47 48 49 50 ±2

L 57 59 62 64 66 ±2

The dimensions of the gowns above are the Standard dimension of standard surgical gown

and can be as well customized depending on customers’ request.

2.7. PACKAGING

The standard surgical gown in its sterilization pouch pack is then double packed in order to reduce all

the risks it may encounter during its transportation.

The Standard gown packed in foil-paper packaging is required to be accompanied by a technical card

to confirm the required parameters.

The double packed standard surgical gowns are put in standard sized carton which

dimensions are: Height = 44 cm; Length = 40 cm and Width = 60 cm.

On the outer packaging there are two self-adhesive labels for documentation purposes including:

catalogue number,Product SAP Code, LOT Number, expiry date and manufacturer's name.

2.8. OPTION AVAILABLE ▪ Custom dimensions

▪ Ultrasonic Welding

▪ Amount of Towels

▪ Wrap

3. SHELL LIFE

The Standard surgical gown has a Shell life of 3 years.

4. STERILIZATION PROCESS

The well packed gowns in their respective boxes with their individual identification labels are then

sterilized using Ethylene oxide gas (EO Sterilisation). Each sterilization process is strictly controlled

and appropriate data ( temperatrure, duration, humidity and gas concentration) are collected by

experimented personel. All these data are then saved to our SAP system for traceability. These data

can be provided for each sterile product by the bias of their Lot number, reference number and

product code.

5. STORAGE CONDITION

Store under ambient temperature and dry condition.

6. REGULATORY

Class IS Rule 1 MDD 93/42/ECC Annex / IX MDD 93/42/ECC

ISO 9001

ISO 13485:2016

EN 13795-1

OEKO-TEX STANDARD 100

7. COUNTRY OF ORIGIN

This standard surgical gown is entirely manufactured in TURKEY.