How Are Sterile Surgical Gowns Packaged? - News

The packaging of sterile surgical gowns consists of two layers: a single small package and a medium-sized outer package. Both layers comply with the GB/T 19633 standard, "Test Methods for Packaging of Sterile Medical Devices." The core requirements are to ensure sterilization effectiveness, sterility, and ease of use. The mainstream packaging method is a single paper-plastic composite bag. Specific specifications are as follows:

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01.

I. Core Single Packaging (Direct Contact with Surgical Gown, Sterile Layer After Sterilization)

1. Common Materials: Paper-plastic composite bag (medical dialysis paper + transparent plastic film). The paper side is breathable for sterilization gas to pass through, while the plastic side is waterproof and contamination-proof, allowing direct observation of the interior.

2. Packaging Method: The surgical gown is folded according to aseptic procedures (with markings/folding positioning on easily torn areas such as cuffs and waistbands), placed flat in the bag, and heat-sealed. The seal width is ≥6mm, with no leaks or wrinkles.

3. Key Markings: The bag surface is printed with the production batch number, sterilization date, expiration date, sterilization method (mostly ethylene oxide/moist heat sterilization), sterility label, product specifications, manufacturer, and some include a traceability QR code.

02.

II. Outer Packaging (Containerized Protection, Non-Sterile Layer)

1. Common Materials: Medical-grade laminated non-woven bags, cardboard boxes, or sealed plastic film, providing protection against compression, breakage, and moisture.

2. Packaging Specifications: Packed according to clinical needs, typically 10/20/50 pieces per carton/bag. The outer carton is labeled with the same core information as the inner bag, along with storage and transportation markings (moisture-proof, handle with care).

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Packaging Requirements

1. Packaging materials must be heat-resistant/ethylene oxide-resistant, compatible with the sterilization method, and free from harmful substance leaching;

2. After sealing, there must be no damage or air leakage, and the dialysis paper must be free from perforations or tears;
3. Folded surgical gowns must be able to be opened and worn directly with one hand under aseptic conditions, without needing to touch non-sterile areas.