[Case Study] The Filing of Medical Isolation Gown

[Case Analysis] The Filing of Medical Isolation Gown

As a medical protective device, the medical isolation gown has played a significant role in the prevention and control of the epidemic, and it is also an emergency supplies. The medical device service team of CIRS Group, based on the national epidemic prevention and control requirements and corporate needs, urgently assisted a number of enterprises to file their medical isolation gowns. In conjunction with the emergency approval policy during the epidemic prevention and control, we now share the filing requirements and processes of medical isolation gown as follows:

1. Overview of medical isolation gown products

- Product name: Isolation gown

- Structural composition: Isolation gowns are usually made of non-woven fabrics through cutting and sewing. Non-sterile, single-use.

- Working principle : Use the barrier effect of clothing to protect medical staff from contamination by blood, body fluids and other infectious substances, or to protect patients from infection.

- Intended use: For general isolation in medical institutions' clinics, wards, test rooms, etc.

- Target user: Suitable for people who need protection in various environments.

- Intended use environment: medical institution clinic, ward, laboratory, etc.

2. Medical Isolation Gown Classification Information

Medical isolation gowns are managed in accordance with the Class I medical devices, and the medical device filing process needs to be completed as required.

3. Clinical trial requirements for medical isolation gowns

Not required: Class I medical devices do not require clinical trials

4. Technical requirements for medical isolation gown

4.1 Appearance

1) The gown should be dry, clean and free of mildew spots, and no defects such as adhesion, cracks, holes, etc. are allowed on the surface.

2) The connection part of the gown can be processed by stitching, bonding or heat sealing. The needle eye of the needle seam should be sealed. The needle pitch should be 8 ~ 14 stitches every 3cm. Adhesive or heat-sealed parts should be flat and sealed without air bubbles.

3)The zipper of protective clothing equipped with zipper should not leak, the zipper slider should be able to lock itself

4.2 Structure

1)The structure of the isolation gown should be reasonable, easy to put on and take off, and tightly bonded.

2) Adopt elastic cuffs at the cuffs and ankles; And adopt elastic closure, drawstring closure, or buckle at the neck and waist。

4.3 Model specifications

Medical isolation gown models are generally divided into 160, 165, 170, 175, 180, and 185. See the specifications in Table 1 and Table 2. (Refer to GB 19082-2009 Technical Requirements for Medical Disposable Protective Clothing)

Table 1 One-piece type specifications

Unit: cm

Table 2 Split type specifications

Unit: cm

Model	Clothes Length	Chest	Outside Length	Waistline
160	76	120	105	100~105
165	78	125	108	105~110
170	80	130	111	110~115
175	82	135	114	115~120
180	84	140	117	120~125
185	86	145	120	125~130
Deviation	±2	±2	±2	±2

4.4 Moisture resistance

The spray rating on the outer side is not lower than level 3.

4.5 Breaking strength

The breaking strength of the material of the critical part of the gown shall not be less than 45N.

4.6 Elongation at break

The elongation at break of the material of the critical part of the gown shall not be less than 15%.

4.7 Microorganisms

Meet the requirements of microbial indicators in GB 15979-2002, see Table 3

Table 3 Microbiological indicators

Total bacterial colonies CFU/g	Coliform	Pseudomonas aeruginosa	Staphylococcus aureus	Hemolytic streptococcus	Total fungal colonies CFU/g
≤200	Not detectable	Not detectable	Not detectable	Not detectable	≤100

5. Technical standards applicable to medical isolation clothing

6. Recording duration of medical isolation gown

As a Class I medical device, the medical isolation gown goes through the filing system, and submits filing materials on the spot. After passing the on-site review, a filing voucher is issued on the spot.

The filing voucher of medical isolation gown contains two parts: the Class I medical device filing voucher and the Class I medical device filing information form.

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