Model Name: Surgical Gown
- Product descriptions:
- The gown is made of SMS fabric (spunbond–meltblown–spunbond), which is a soft material giving cozy feeling for the clinicians or the users.
- The SMS structure(nonwoven fabrics) has the same level of comfort as garments made from microfiber, while its Intricate web of microfibers filters out many water-based liquids
- The breathable material can keep the wearers cool while putting on the gown for a long surgical time.
- The surgical gown consists of a critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings.
- This protective wear is able to provide barrier protection for health care patients and health care personnel from the transmission of micro-organisms, body fluids and small substances.
- The product has been tested for barrier performance per ANSI/AAMI PB70:2012. Testing was performed according to the 2 of 6 Guidance on 510(k) Premarket Notification Submissions for Surgical Gowns and Surgical Drapes and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. All results of testing met AATCC-42/AATCC-127, and meets AAMI PB70:2012 Level 3 requirements. (Heavy-weight SMS – for AAMI Test level 3; Medium-weight SMS – for AAMI Test level 2; Light-weight SMS – for AAMI Test level 1)
- A 510(K) Premarket Notification Submission is made to FDA to demonstrate that the device to be marketed is at least as safe and effective.
- The Surgical Isolation Gown is a single use, disposable, and non-sterile medical device.
- Model Number: MSIG-1001
- Type: Gown
- Certificate: FDA, CE, EN ISO 13485
- Instrument Classification: II
- Material: Multi-Ply material
- Size: Universal
- Style: Full closed back with elastic wrists and tape tab neck
- Sterility: Non-sterile
- Place of origin: China
- Color: Yellow
- Package: 10 pieces/bag, 5 bags/carton
- ODM: Welcome
- FOB Price:
- USD $0.185 – 0.6/piece
- Price terms:
- FOB or other
- 30% T/T prepaid and 70% at sight L/C
- 10000 pieces
- Shanghai or Wuhan
- Lead time:
- 20-30 days after prepayment arrived
|AAMI Level||Risk||Use example|
|Level 1||Minimal risk||during basic care, standard isolation, cover gown for visitors, or in a standard medical unit|
|Level 2||Low risk||during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab|
|Level 3||Moderate risk||during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases|