TG011 AAMI Level 3 Surgical Gown | Hubei Haixin

The TG011 is a disposable surgical gown for hospitals and other care settings. It helps protect medical staff from blood, body fluids, and other liquids.

Hubei Haixin supplies TG011 to hospitals, medical distributors, surgical centers, and other healthcare buyers. You can choose the material, size, color, packaging, and antisepsis method to fit your market and order.

Buying an AAMI Level 3 surgical gown? Don’t just look at the fabric. Check the whole product spec. It should match the protection level you need, the intended use, covered areas, labels, and local rules.

TG011 Surgical Gown at a Glance

What Is an AAMI Level 3 Surgical Gown?

AAMI Level 3 is a liquid-protection level for healthcare protective clothing.

The FDA uses ANSI/AAMI PB70 to rate how well protective clothing blocks liquids. It says Level 3 is for moderate-risk tasks like blood draws, IV insertion, ER procedures, and trauma care.

If you’re a B2B buyer, don’t treat “AAMI Level 3" as just a sales pitch.

A complete product specification should connect:

intended use → protected areas → material structure → barrier testing → labeling → regulatory documents

This helps purchasing teams compare suppliers based on clear product requirements instead of product names alone.

Why Choose the TG011 Surgical Gown?

1. Protection Against Liquids

TG011 serves healthcare settings where staff may come into contact with blood, body fluids, and other liquids. The test reports should show the protection level matches the intended use.

2. Breathable Nonwoven Material

TG011 can use SMS or SMMS nonwoven, depending on order needs. Outer spunbond layers add strength and easier handling. The meltblown layer creates the liquid barrier. For big orders, Haixin can talk through material options based on:

• Required protection level
• Fabric weight
• Breathable
• Target cost
• Intended market
• Sterility requirements
• Packaging requirements

3. Secure Cuffs and Closures

The long sleeves and elastic knitted cuffs help create a secure fit with gloves.

You can also adjust the neck and waist closures to meet the buyer’s requirements.

These details are important for hospitals and other large buyers because they affect:

• Putting on and removing the gown
• Fit
• Freedom of movement
• Connection with gloves
• Comfort during procedures
• Product consistency

4. Reinforced Construction Options

Haixin can add reinforced areas or use different seams depending on the protection level. Ultrasonic welding is available on some setups. The final seam design should match the test report and regulatory docs. Don’t just trust vague claims like “high barrier."

TG011 Material Options: SMS vs SMMS

The previous product description uses both SMS and SMMS. These are different materials; do not treat them as the same.

The page should list the material actually used—the same one in the test report. For big orders, Haixin can share material details before production starts.

AAMI Level 3 vs AAMI Level 4

AAMI 3 and 4 aren’t the same—don’t swap the claims. FDA says Level 3 = moderate liquid protection. Level 4 = higher-risk, with different performance requirements.

Therefore, the phrase:

“AAMI Level 3 / 4 Equivalent"

should be removed from the standard product page unless separate test reports support both claims.

For a product marketed as TG011 AAMI Level 3, use this clear structure:

TG011 → AAMI Level 3 → intended use → test evidence

Do not use:

TG011 → Level 3/4 equivalent

This wording helps hospital buyers understand the product and reduces confusion about regulatory requirements.

Buyers comparing different protection levels can also review our AAMI Level 4 surgical gown options.

Surgical Gown Critical Zones

The protected areas matter as much as the fabric. FDA lists the key ones: front of the body, shoulders to knees, and arms, wrist cuff to above the elbow.

Buyers should check:

• Front-panel protection
• Sleeve protection
• Cuff design
• Seam construction
• Closure design
• Fabric performance
• Product labeling

Suppliers should provide the relevant test documents for the exact product configuration.

TG011 Size Specifications

The current product page lists the following sizes:

These measurements come from the current product specification.

For OEM projects, Haixin can discuss:

• Custom size grading
• Sleeve length
• Gown length
• Cuff design
• Reinforced areas
• Color
• Labeling
• Packaging

Sterile and Non-Sterile Supply Options

TG011 currently lists both sterile and non-sterile. Final spec should split them out. For a sterile surgical gown, buyers should confirm:

• Antisepsis method (EO, gamma, etc.)
• SAL level (usually 10⁻⁶)
• Validated antisepsis process
• Sterile barrier packaging and seal integrity
• Shelf life / expiration date
• Lot or batch traceable
• Labeling: sterile symbol, single-use, manufacturer info
• Correct AAMI level for the intended use
• If US market: real FDA 510(k) for that exact device and maker

Don’t just take “sterile" as a marketing word.

B2B Procurement Specifications

TG011 suits buyers who need a stable supply program instead of a one-time retail order.

Common purchasing requirements include:

Hospital Procurement

• AAMI protection level
• Material details
• Size range
• Sterile or non-sterile status
• Packaging
• Shelf life
• Regulatory documents
• Sample approval
• Production capacity

Medical Distributor Procurement

• Private-label packaging
• Carton configuration
• Product labels
• MOQ
• Container loading details
• Delivery schedule
• Country-specific documents

OEM / ODM Projects

Haixin can discuss custon of:

• Fabric structure
• Product dimensions
• Color
• Cuff design
• Closure system
• Reinforced areas
• Logo
• Label
• Individual packaging
• Carton packaging
• Antisepsis method

Packaging for Bulk Orders

The current product specification lists:

• 1 surgical gown per bag
• 50 gowns per standard carton
• Customized packaging available

Buyers should confirm the packaging before production because sterile and non-sterile products may need different packaging.

For container orders, Haixin can also provide:

• Carton dimensions
• Gross weight
• Net weight
• Estimated loading quantity

Quality and Compliance Documentation

For medical PPE, cert names alone aren’t enough. Buyers should ask for docs that match the exact product setup. Depending on where you’re selling and what you claim, the doc pack may include:

• Product specification sheet
• Material specification
• Liquid-barrier test report
• AAMI PB70 test report, where applicable
• ISO 13485 quality-system documents
• CE-related documents, where applicable
• Antisepsis documents for sterile products
• Biocom-patibility documents, where applicable
• Packaging validation documents
• Label artwork
• Country-specific regulatory documents

FDA recognizes ANSI/AAMI PB70 for liquid-barrier ratings. US buyers: saying “510(k)" isn’t the same as real FDA 510(k) clearance for that exact device and maker.

Why Source TG011 from Hubei Haixin?

Hubei Haixin makes disposable medical and protective nonwovens in Hubei, China. For B2B buyers, going straight to the maker helps match the product to your needs before mass production.

Haixin supports bulk orders with:

• 5,000-piece MOQ for TG011
• Large-volume production
• Material custon
• Size custon
• Color custon
• Packaging custon
• OEM / ODM services
• Export-focused B2B supply

The current product page lists a supply capacity of up to 1,000,000 surgical gowns per month.

How to Order TG011 AAMI Level 3 Surgical Gowns

For an accurate quotation, send the following information:

1. Required AAMI level
2. Intended use
3. Sterile or non-sterile requirement
4. Material preference: SMS or SMMS
5. Required sizes
6. Order quantity
7. Color
8. Individual packaging requirements
9. Carton requirements
10. Destination country
11. Required regulatory documents
12. OEM or private-label requirements

Request a TG011 Surgical Gown Quote

Contact Hubei Haixin for samples, product specifications, compliance documents and bulk pricing.

For an RFQ, provide the order quantity, destination market and required protection level. Haixin can then confirm the suitable product configuration and document package before mass production.

Frequently Asked Questions

Is TG011 an AAMI Level 3 surgical gown?

TG011 is available in an AAMI Level 3 configuration. The final AAMI Level 3 claim should match the test report and product label for the exact production configuration.

What material does TG011 use?

The current product specification lists SMMS, while the product title lists SMS. Buyers should confirm the exact material before ordering because SMS and SMMS have different structures.

Is TG011 sterile?

We can supply TG011 in either sterile or non-sterile form. The order should clearly state the required antisepsis method, packaging and documents.

Can Haixin customize TG011?

Yes—Haixin can customize material, size, color, closures, reinforcement, labels, and packaging, within production and regulatory limits.

What is the MOQ for TG011?

The current product page lists a minimum order quantity of 5,000 pieces.

What is the production capacity?

The current product page lists a supply capacity of up to 1,000,000 surgical gowns per month. Haixin should confirm the actual capacity and lead time based on the production schedule and order details.

Can Haixin provide documents for hospital procurement?

Yes. Buyers can request product specifications, test reports and regulatory documents based on the destination country and product configuration.

What is the difference between AAMI Level 3 and Level 4?

AAMI 3 handles moderate liquid risks. AAMI 4 is for higher-risk cases and has different specs. Pick the right one based on your procedure and regs.

Related Surgical Gowns & SMMS Level 3 Surgical Gown & AAMI Level 4 surgical gown