Surgical Gown Manufacturer and Supplier
As a professional surgical gown manufacturer, Crown Name Group has developed for more than 20 years. We can manufacture spunlace surgical gowns, SMS surgical gowns (including SMMS, SMMMS), and film-based laminates surgical gowns. Now, follow us to know more about the various information about surgical gowns.
What materials are used by surgical gown manufacturers to make surgical gowns?
Surgical gown manufacturers mainly use non-woven fabric to produce surgical gowns. Non-woven fabric has the characteristics of moisture-proof, breathable, flexible, light, flame retardant, non-toxic and tasteless, low price, reusable, and so on. More specifically, it can be divided into the following categories:
Spunlace non-woven fabric is the high-pressure fine water jet to a layer or multi-layer fiber net so that the fibers are entangled together so that the fiber net can be reinforced with a certain strength.
It is also called Spunbond + Meltblown + Spunbond Nonwovens. It has a completely different production process compared to the former and is a composite nonwoven made of three layers of material. SMS nonwoven fabric is widely used in surgical gowns, disposable coveralls, scrub suits, etc.
Customization options are accepted by surgical gown manufacturers.
We accept customization for surgical gowns. It concludes with options about size, color, and styles.
Styles: You can choose whether to add reinforcement at the front and sleeves.
If you have unconventional needs, please let us know in time, so that we can serve you the first time.
We also offer a selection of standard sizes, M, L, XL, XXL，
M 120 145 55 , L 130 150 60, XL 140 160 65, XXL 150 170 65
The cost of customization is not the same as that of the standard model, because we need to adapt and improve the line for your requirements.
Which standards in EU regulations do surgical gown manufacturers follow?
Surgical Gown Products from Crown Name Group meet the requirements of EN ISO13485:2016.
[ISO 13485：2016 Medical devices——Quality management systems——Requirements for regulatory purposes. ]
Our 45g SMS surgical gown passed EN13795. 35g/40g/45g SMMS surgical gown passed EN13795-1. EN13795, the European consensus standard for surgical gowns, surgical drapes, and clean air suits.
ISO 13485:2016 outlines the requirements for a quality control system in which an organization has to prove its capability to offer the medical device and associated services to meet the needs of customers and regulatory requirements. These organizations may be involved in any of the phases of the life-cycle such as the development and design manufacturing, storage, distribution, installation, or service of a medical device, as well as the design and development of related services (e.g. tech support).
ISO 13485:2016 is also used by suppliers and other companies that offer product and quality management system-related services to these organizations.
What protection level can be achieved by different types of surgical gowns?
ANSI/AAMI PB70-2012(Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities)
Minimum barrier performance requirements, classification systems, and associated labeling requirements are established for a variety of garments used in healthcare facilities. The standard's barrier performance requirements cover surgical sheets, draping accessories, and all types of protective garments with liquid barrier statements or liquid-borne microbial barrier statements (e.g., disposable and multi-use gowns, decontamination gowns, isolation gowns, aprons, cuffs, and laboratory garments).
The surgical gown currently on sale on the market is mainly based on the ANSI/AAMI PB70 classification of products in four levels: based on standardized test results, four levels of barrier performance are defined, level 1 is the lowest level of protection, level 4 is the highest level of protection.
Surgical gowns manufacturer announced their surgical passed ANSI/AAMI PB70-2012.
The 45g SMS and 35g SMMS surgical gown achieved level 2 standards.
SMMS surgical gown achieved level 3 standards.
If you want to get more information, please contact us.
Precautions in the use of surgical gowns.
All disposable surgical gowns manufactured by surgical gown manufacturers are sterilized and hermetically sealed. Please stop using it immediately if the package is broken.
Wash and disinfect your hands before putting on the sterile surgical gown. Grasp the uppermost part of the surgical gown with one hand and pick it up, taking care not to contaminate the rest of the gown. Lifting the collar of the surgical gown with your hands and unfold the surgical gown gently. (The side with the belt facing outward)
Next, Throw the surgical gown slightly upward and put your hands into the sleeves at the same time.
The nurse assists in dressing from behind so that the hands are out of the cuffs. Lean forward slightly so that the belt dangles away from the surgical gown, lift the left and right belts with crossed hands and pass them to the rear, and have the nurse fasten the belt behind the body.
When finished the surgical, take off the surgical gown first, and then take off the sleeves. The whole process also requires two people to cooperate with each other. The surgical gown should be disposed of properly according to the hospital procedure and should not be discarded.
Are these surgical gown products reusable?
No. We are a disposable surgical gown supplier. All surgical gowns are not reusable. To avoid surgical accidents, please strictly prohibit this behavior.
Disposable materials can be discarded and recycled directly after use without additional costs for reuse, making them relatively inexpensive. Disposable surgical gowns are lighter in weight and more comfortable to wear.
How to choose a reliable surgical gown manufacturer?
Price is not only a factor that influenced the final choice but also many other factors you should consider.
Company strength. The supplier's experience is an invisible guarantee of product quality.
A company that can survive in the industry for ten or twenty years will be better in product quality control and trust than a company that has just been established for a few years.
Factory size. Many buyers will go to the manufacturer's factory location for on-site inspection before making the main choice, this way it ensures the credibility of product quality.
This includes the mental state of the staff, the environmental health of the factory, the factory production process, and other aspects.
How should Crown Name Group surgical gowns be stored?
The surgical gown is sterilized and encapsulated before it leaves the factory. Before storage, the warehouse is disinfected and the external packaging is not damaged during storage. The overall environment is clean, dry, well ventilated, and away from fire.
If the above conditions are met, the surgical gown can be preserved for about xx-xx years. There is no need to worry about the loss of protective effect due to material deterioration.
What tests do the surgical gown manufacturer's products pass?
Part I EN13795-1-2019
The following test results are labeled M:
Tensile Strength As Received
Bursting Strength As Received
Hydrostatic Head Test As Received
Cleanliness Microbial / Bioburden
Lint And Other Particles Generation In The Dry State
The Resistance to Dry Microbial Penetration (CFU)
The Resistance to Wet Bacterial Penetration
Note: M= Meet Standard’s Requirement
Part II ANSI_AAMI PB70-2012
Different grams of surgical gowns to achieve different levels of protection. Our products cover both Level 2 and Level 3 ranges.
Explanation from the surgical gown manufacturer about OEM/ODM issues.
As a surgical gown manufacturer, crown name group provides total solutions for non-woven products, which can all be customized based on clients’ requirements
Clients may create their own branding including CE labels, packages, CE certificate extensions, etc. With nearly 30 years of manufacturing experience, Crown Name Group
provides professional technical advice for clients to build their own product brands efficiently.
Crown Name Group tailored-made process listed as the following:
>Concept – Review users’ painful points while determining their requirements of the application, environmental hazards, and required protection level.
>Prototype – Make a prototype sample after the concept is confirmed.
>Validation – Allow users to proceed with field tests on the prototype and evaluate if sample improvement is required based on users’ feedback.
>Quotation – Provide a quotation after the prototype is confirmed.
>Mass Production – Conduct mass production and provide training materials upon request.
>Tracking – Follow up feedback and upgrade design for better users’ experience if necessary.
Please feel free to contact our professional team if you need any further assistance.
Any other questions about surgical gowns or surgical gown manufacturers?
After reading all the above information, if you still have questions, please contact us. Crown Name Group will try our best to solve the problem for you. We welcome every inquiry from our customers, whether it is about our products or our company.