9-point Inspection Checklist for Surgical Gowns Quality Control

TESTCOO/October 22, 2021

Surgical gown is one crucial piece in healthcare medical industry to prevent the transferring of microorganisms and body fluids from patients to healthcare personnel and vice versa. With most of the surgical gown supply chains located in countries far away from the brand buyers, it is important to ensure the quality of surgical gowns before shipment. So conducting a factory inspection for surgical gowns can bring great significance to brand buyers to avoid failed products and the risk of product recall. Here is a guide to check the surgical gowns in a factory by QC.

ANSI/ASQ Standard to determine the right sample size and acceptance number

Firstly, the inspection follows ANSI/ASQ Standard Z1.4: AQL 2.5 for major defects and AQL 4.0 for minor defects. Take samples at random from the bulk production and perform visual inspection for each surgical gown sample to inspect its makes and workmanship. Garments that with better workmanship should have fewer visual defects and both major and minor defects are within AQL levels. Considering surgical gown, minor defects could be a reference but not a result of failure.

Inspection checklist for surgical gown quality control

1. Cleanness

Any kind of stain or smear is a major defect, either a dirty stain or a color stain.

2. Seam performance

Any open seam is a major defect.

3. Cuff stitching and Velcro

Any broken stitch is a major defect, but skipped stitch, exposed stitch or uncut thread end may be a minor defect. Velcro is positioned correctly and easy to use.

4. Asymmetrical sleeves

It is a major defect if the asymmetrical distance is over 2 cm, while it may be judged as a minor defect if the distance is between1-2cm.

5. Size measurement

Check all the sizes of the surgical gown according to the size chart or sample provided by the client. Differs from normal garment, the size measurement tolerance is suggested +2/-1 cm, while +/-1cm tolerance is widely used in normal fashion industry.

6. Unit Weight measurement

The weight of each surgical gown should follow the data or sample provided by the client. Apply +/- 3% if no detail tolerance issued or requirement from client.

7. Carton dimension and weight checks

Record the carton dimension and weight. Make sure that the carton size complies with the specification of the destination country.

8. Product packing details

Each package should include, for example, the surgical gown, the label card and the qualification card, and the information of the cards is clear.

9. Water resistance function test

The water resistance test is crucial for surgical gown as surgical gown is mainly used to prevent health care personnel from being exposed to body fluids and microorganisms.

The AAMI (Association for the Advancement of Medical Instrumentation) is the standard to establish the classification system for protective apparel used in health care facilities based on liquid barrier performance using standardized test methods. Within this standard, AAMI has applied AATCC (American Association of Textile Chemists and Colourists) 42 and AATCC 127 methods to test the efficacy of surgical gowns.

AATCC 42 Water Resistance: Impact Penetration

This test indicates how the surgical gown will resist strikethrough when fluids splash or spray onto the surgical gown. Spray 500±10mL water against the taut surface of a test specimen backed by a weighted blotter. The blotter is then reweighted to determine water penetration and the specimen is classified accordingly. Garments that are more protective should have less water penetrating the fabric of test sample, which means, lower levels are better water resistance.

AATCC 127 Water Resistance: Hydrostatic Water Resistance

This test shows how the surgical gown will resist strikethrough when water pressure is applied to the surface of the surgical gown. Hydrostatic pressure tests the fabric for fluid resistance by measuring the force required for water to penetrate it (including seams). One surface of the test specimen is subjected to a hydrostatic pressure, increasing at a constant rate until three points of leakage appear on its other side. Garments that are more protective should be able to withstand higher levels of pressure before droplets form, which means, higher levels are better water resistance.

Both of the two water resistance tests do not have a fail / pass benchmark as they are observation tests only, with results recorded after each observation. It is the AAMI PB70 standard that determines the pass/fail of the surgical gown based on the Acceptance Quality Limit (AQL) requirement.

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If you need some practical experience in quality control, you can definitely discuss with us. As a Chinese inspection company, we can provide product inspection, factory audit, lab testing, and Amazon FBA inspection. Contact us for a detailed quality control solution for your requirements.

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