Gauze Swabs

Features:

● Made of superior quality cotton threads type 40/40, highly absorbent, and super soft.

● The edges are double folded into so-called”S” folding, so no loose threads stick out.

● It can be sterilized with ethylene oxide or gamma radiation.

● Available with a sewed in X-ray detectable thread, which make gauze swab could be identified quickly in the operating field.

Indications:

● Ideal for the light bleeding, large surface cuts, scrapes, burn or post-surgical wounds.

● With X-ray thread or without X-ray thread are available.

● Folded edge or un-folded edge are abailable.

● Five units package choice: Blister pack, Paper+PE pouch, Paper+Paper pouch, Paper bag, paper box.

It is intended in use for cleaning, homeostasis, absorbing interior and exudation in surgery operation or wound, they are widely used in hospital and clinic, their raw materials are adopted natural plant, they are woven into different tabby cloth after spinning, and then the cloth must be degreased and bleached. The product has no broken leaves, cottonseed shell and other impurities; it is pure white and soft; it has no textile defects, and it belongs to typical cotton fiber product. They are well tensile and water absorbent, present neutral, no odor, no chemical reaction with acids, alkalis, alcohol and ether, etc., they do not contain any colored materials.

Structure:

The Gauze dressings belongs to natural plant which was spun to plain cloth with different specifications and the gauze was made of degreasing and bleaching. The products contain no leaf pieces, cottonseed shell and other impurity without spinning defect. It is typical cotton fiber with obvious tensile-resistance property, well absorbency, without odour. The absorbent gauze appears neutrality which will not bring chemical reaction with acid, alkali, ethanol and anther without containing any colored material. Its manufacturing process is performed in 100000 class clean room, except the transport packaging and sterilizing.

Matters needing attention:

1. The product can only be used once, and it should be used immediately after being destroyed;

2. Check whether the packaging is intact before use, packaging damage, or moldy, yellow is strictly prohibited. Keep the product dry and well ventilated. To prevent high temperature and humid place, away from corrosive gases.

3. Products must be sterilized. Each test item must meet the standard before use.

Valid period is 5 years from the date of manufacture.

Wound cleaning, hemostasis, absorbing blood and exudation from wound in surgery operation.

Bandaging method:

1. (1). The common way: after bandage stretched, one end is a, the other end is b, the right hand holds the scroll bar tightly, the left hand holds the belt end, and the bandage that it is attached to the patient's bandaged part.

(2). The end of Gauze is below the bandaging site and cerclage the bandage,

To expose the oblique corner and then, to fold down it, two – three circles with cerclage.

(3). It is fixed with tape or safety pin, to leave the appropriate length and then tie a knot after cutting.

2. Circle wrapping:

It is used on small cut like as neck, wrist, etc.

Overlapping winding at least two circle,

Fold the edge of gauze and fix it with glue or safety pins, or cut the middle of the end of the bandage and divide it into two ends to avoid knotting the wound area.

Sterile Gauze Swabs / Sterile Gauze Sponges / Sterile Gauze Pads, Sterile Gauze Swabs with x-ray detectable thread, Sterile Gauze Roll and Sterile Gauze Bandage.

ETO Sterilization Validation:

The EtO sterilization procedure of Medical Gauze will be verified as the following processes

Sterilization of medical products is the necessary procedure to make the medical instruments free from bacteria. To verify and monitor the effectiveness and reasonable of sterilization procedure is to ensure the products to be non-bacteria. So the ETO sterilizing procedure of Nebulizer Mask produced by this company will be verified as the following processes:

Sterilizer:

The sterilizers to be validated this time are HDX 20M³ sterilizer produced by Hangzhou Dian Da Sterilizer Factory. The 20M³ sterilizer was produced in March 2002 and was purchased in May 2002, All parameter of the equipment can be set, and the whole processes are monitored and administered by computer.

Loading and stacking pattern:

According to requirements of 3.1, the packages of sterilized products are put into plastic turnover circles of 60×40×32 cm, 100 pieces in each circle, totally 100 circles, the pattern, the spaces between circles with the right and left walls of sterilizer are 50~70mm, the space between circles with the front and back walls of sterilizer are 100~150 mm, the spaces between top of sterilizer are 60～120mm, the spaces between bottom of sterilizer are 145～155mm,the space of circles is 35~40mm

Definition products

The normal environment control is according to Environment Control Way of Clean Area and Environment Control Way of Normal Producing Area, so that initiated contaminated bacteria on product is assured to be controlled in the scope of 100 cfu/g. test the initiated contaminated bacteria on products before sterilization see <Initiated contaminated bacteria Test Report.

Sterilization gas:

100%EO produced by Wuhan Air Water Special Gas Research Institute, which has passed ISO and CE certified, whose technical target is conform to <EO---- fumigant of carbon dioxide> from China Chemical Industry Research Institute of Chemical Industry Ministry.

Validation method(Half time circulation)

According to the former sterilization experiences and results, 2 hours of verification time needs to sterilize one time, 3 hours of verification time needs to sterilize 3 time , 4 hours of verification time needs to sterilize one time . If 2 hours of verification time shows there are bacteria grown, 3 hours of verification time shows there aren’t bacteria grown, 4 hours of verification time shows there aren’t bacteria grown, then can conform the sterilization time is 6 hours according to the half time circulation. If 3 hours of verification time shows there are bacteria grown, 4 hours of verification time shows there aren’t bacteria grown, then it needs to verified 4 hours of verification time two times, 5 hours of verification time needs to sterilize one time, if the two times about 4 hours of verification time shows there aren’t bacteria grown, and 5 hours of verification time shows there aren’t bacteria grown, then can conform the sterilization time is 8 hours according to the half time circulation.

Flow chart of medical gauze swabs:

Note: ★ means special process

Nonwoven Sponges / Nonwoven Swabs.

Non-Woven Sponges is single use medical dressing which contacts human body directly and they have been used for more than one hundred years. The raw materials are adopted natural plant, they are woven into different tabby cloth after spinning, and then the cloth must be degreased and bleached. The product has no broken leaves, cottonseed shell and other impurities; it is pure white and soft; it has no textile defects, and it belongs to typical cotton fiber product. They are well tensile and water absorbent, present neutral, no odor, no chemical reaction with acids, alkalis, alcohol and ether, etc.; they do not contain any colored materials. After sterilization the product has no bad stimulation to skin and mucosa, no allergic reaction and other harmful effect. In the process of using it, it will not bring out poisonous matter.

Intended uses of product:

Sterile Non-Woven Sponges with X-Ray is used for large area wound cleaning, hemostasis, absorbing blood and exudation from wound in surgery operation.

Caution:

1) The product can be used only once, should be used immediately after opening the package and destroyed afterwards.

2) The period of validity is 5 years from the date of manufacture, must use it during the validity period.

3) Do not use if package is damaged.

4) Store in a place it avoids high temperature, high humidity, and does not have corroding gases, should have good dryness and ventilation.

Situations of Product Selling and Feedback from Clients:

Since the foundation of the company, we always select the suppliers, which have mature technology, good quality, manufacture by machine, having passed the quality management system and CE certificate according to ISO13485 and MDD directive requirements. The company has established trade relation with many countries such as Southeast Asia, Middle East, South Asia, Middle South Asia, Africa, Europe and U.S.A. etc.

Since our company sold Sterile Non-Woven Sponges with X-Ray, according to the

result of client, from the production capability, environment and quality system of suppliers, these things mean the products are safe. It has never received any complaint of customers with the product quality such as their physical-chemical specifications, and never leads or has led to death or health deterioration of users or patients.

Sterile Gauze Swabs / Sterile Gauze Sponges / Sterile Gauze Pads

Sterile Gauze Sponges with X-Ray is single use medical dressing which contacts human body directly and they have been used for more than one hundred years. The raw materials are adopted natural plant, they are woven into different tabby cloth after spinning, and then the cloth must be degreased and bleached.

Production environment, package and sterilization

The production and assembly of the whole product are finished in relative clean warehouse which meet the requirement. And the inner packing selects skin pacing. After large packing, all the products are sterilized by radiation for single use.

According to the requirements of BP93 , we random sampling and test any batch raw materials of absorbent gauze, the inspect items and standards are listed in

Table 1:

Table 2:

Table 3: We inspect each batch raw material of non woven gauze in sampling at random, following is the inspected items and standards:

Table 4: We inspect each batch raw material of aluminum-plating gathers the fat membrane in sampling at random, following is the inspected items and standards:

Table5: We inspect each batch raw material of crepe bandage in sampling at random, following is the inspected items and standards:

Conclusions:

It is qualified only when all the foregoing inspect items conform to the requirements, and it is not qualified when there is one or more items is not accord with the requirement, so putting into production is not allowed. Our company’s CE products place on the market on the condition that the inspection is qualified.

It is possible but we must use Sterile Gauze.

Purpose and references

Purpose of study

This study is planned for the biocompatibility evaluation for Sterile Gauze Sponge. The purpose of this assessment is to ensure that no undue risks arise from biological hazards associated with raw materials, manufacturing process and final devices.

References

Most of the contents are prepared by being referenced the following standards.

· EN ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

· EN ISO 10993-10:2013 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

· EN ISO 10993 -5:2009 Biological evaluation of medical devices - Part 5 Tests for in vitro cytotoxicity

Device description

Product name

Sterile Gauze Sponge

Overview

Sterile Gauze Sponge is single use medical dressing which contacts human body directly and they have been used for more than one hundred years. The raw materials are adopted natural plant, they are woven into different tabby cloth after spinning, and then the cloth must be degreased and bleached. The product has no broken leaves, cottonseed shell and other impurities. It is pure white and soft; it has no textile defects, and it belongs to typical cotton fiber product. They are well tensile and water absorbent, present neutral, no odor, no chemical reaction with acids, alkalis, alcohol and ether, etc., they do not contain any colored materials. After sterilization the product has no bad stimulation to skin and mucosa, no allergic reaction and other harmful effect. In the process of using it, it will not bring out poisonous matter. Usage of the product is quite common and easy, so there is no instruction for usage within the package.

Selection of biological evaluation test

Table 2: Test selection guide by EN ISO 10993-1 Table A.1

Final assessment

Considering the data and reports above, Sterile Gauze Sponge is claimed to be biologically safe for the intended use.

It is based on the size of the wound, level and date of infection, severity of wound and body parts. it can be removed in two or three days if it is a small cut and it needs to be replaced with a new gauze on a deed cut every three days.

Requirements for review of risk management activities

The risk management plan details how and when these management reviews will occur for a specific medical device. The requirements for the review of risk management activities is part of the quality system review requirement.

Table 4: Risk management implementation cycle

OK but it is at most three days, and then it must be removed or replaced with a new one.

Criteria of Risk Evaluation

The criteria for risk acceptability are essential for the ultimate effectiveness of the risk

management process.

For each risk we choose appropriate risk acceptability criteria, which are determined according to our policy for determining criteria for risk acceptability and thus are based upon applicable national or regional regulations and relevant International Standards, and take into account available information such as the generally accepted state of the art and known stakeholder concerns.

Severity Levels

Severity level of each harm must be estimated (in the form of severity level) by the risk management group.

Table 5 : Definition of severity levels

The Gauze has been used for the productive and clinical purpose for scores of years. They are widely used in hospitals and clinic. It has never been reported that the use of the Gauze made from silicone would lead or has led to death or health deterioration of users or patients.

No.

-Factors that should be considered include the location of implantation,

-The characteristics of the patient population, age, weight, physical activity,

-The effect of ageing on -Implant performance,

-The expected lifetime of the implant, the reversibility of the implantation.

Yes, the storage shall avoid high temperature, high humidity, without erosive gas and with good aeration.

-Factors that should be considered include the operational, transport and storage environments.

These include light, temperature, humidity, vibrations, spillage, susceptibility to variations in power and cooling supplies, and electromagnetic interference.

Non-sterile Gauze is Class I Medical Device,

Sterile Gauze without x-ray detectable thread that is Class I Medical Device in sterile conditions,

Sterile Gauze with x-ray detectable thread that is Class IIa Medical Device.