What is the lead time for production?

Peak season lead time is one month, while off-season is within 15 workdays.

What material is used for the gown?

The gown is made from SMS material, which is wearing-resistant and comfortable.

What is the payment method?

We accept LC, T/T, D/P, PayPal, Western Union, and small-amount payments.

FDA AAMI PB70: 2012 Level-3 Operation Room Use Disposable SMS Surgical Gown

Name: FDA AAMI PB70: 2012 Level-3 Operation Room Use Disposable SMS Surgical Gown
Brand: Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.
SKU: 2111169055

Hubei, ChinaAmmex-Weida (Hubei) Health and Safety Products Co., Ltd.

US$0.30-1.20

5,000 pieces

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Feature

Disposable

Certification

CE, FDA, ISO13485

Model NO.

40083

Ethylene Oxide Sterilization

Application

Hospital

Weight

45GSM

Standard

AAMI PB70:2012 Level-3

Color

Dark Blue

Size

Xs-3XL

Specification

1pc/bag, 40bags/cartons, customizable

Trademark

OEM/ Ammex-Weida

Origin

China

HS Code

6210103090

Production Capacity

About 50X40'hq/Month

Key features

AAMI PB70 Level-3 Certified: Meets FDA 510K level-3 requirements for anti-bacterial and water resistance.

SMS Material Construction: Wearing-resistant, comfortable, and non-irritating for skin with ultrasonic sealing.

Customizable Specifications: Customized weight (45GSM), size (XS-3XL), and color (Dark Blue) available.

Ergonomic Design: Features knitted wrists, velcro back neck, and split design for easy wear and storage.

Ethylene Oxide Sterilized: Sterilized via Ethylene Oxide to ensure safety and hygiene for hospital use.

Comprehensive Certifications: Holds CE, FDA, ISO13485, ISO9001, UKCA, and EN14683 certifications.

OEM/ODM Service: Supports custom branding, packaging design, and production from client samples.

100% Quality Inspection: Every finished product undergoes strict visual inspection before shipment.

Company profile

High Repeat Buyers ChoiceYears of Export ExperienceExperienced TeamSelf-branded

Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.

Hubei, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples CertifiedExport Year: 21 Years CertifiedNearest Port: Wuhan PortAverage Response Time: ≤10.49h

AI-Powered supplier vetting

SummaryThe supplier is a limited company with 50 employees, valid import and export licensing, and business activities covering protective equipment, Class I medical devices, plastic products, and related technical services. It reports ISO9001:2015 and other management-system certifications, but product compliance certification is listed only as “Others.” The supplier has documented procedures for service assessment, corrective and preventive actions, and complaint handling. It offers sample-based customization, ODM, and OEM services, and reported new products during the past year, although it is not identified as a professional technical supplier, provides no 3D software design or SDK, and lacks overseas warehouses, showrooms, agents, branches, and offline trade-show experience. Production-related evidence includes multiple equipment categories, two quality inspectors, documented finished-product inspection instructions, and a peak-season order lead time within 15 workdays. Financial credibility and customer...

Supplier typeThe supplier is a limited company with 50 employees and business activities spanning protective equipment, Class I medical devices, plastic products, and technical services. It also holds a valid import and export license, supporting its classification as an export-capable manufacturer or trading/manufacturing enterprise.

CertificationsThe supplier reports an ISO9001:2015 certificate and other management-system certifications, while product compliance certification is recorded only as “Others.” It also reports other sustainable-development and product certification capability, but lacks a factory environmental impact assessment report and did not conduct regular fire drills in the past year.

After-Sales capabilityThe supplier has written procedures and records for service-capability assessment, corrective and preventive actions, and customer complaint handling. However, it reports no overseas warehouse, showroom, agent, branch, or overseas service country, limiting evidence of localized international after-sales support.

R&D capabilityThe supplier reported new products during the past year and provides ODM services, indicating some product-development capability. However, it is not classified as a professional technical supplier, does not provide 3D software design services, and has no available SDK.

Production capacityThe supplier’s stated scope includes production of protective equipment, Class I medical devices, plastic products, and labor-protection equipment. It lists multiple production-equipment categories, uses documented and uniformly followed finished-product inspection instructions, has two quality inspectors, and reports peak-season fulfillment within 15 workdays.

Customization capabilityThe supplier explicitly provides customization from samples and offers ODM services, demonstrating support for sample-based and original-design customization. It also reports OEM capability for popular brands, although no details are provided on tooling, design software, or customization complexity.

Client casesThe supplier states that it provides OEM services for popular brands, which is evidence of at least some brand-customer experience. However, no customer names, project details, order references, or verifiable case studies are provided, so the depth and credibility of its customer portfolio cannot be fully assessed.