SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO

K102692 · Hangzhou Jincheng Medical Supplier Manufacture Co. · FYA · Mar 11, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K102692
• Device Name: SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO
• Applicant: Hangzhou Jincheng Medical Supplier Manufacture Co.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Mar 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Jincheng Surgical Gown is a single use, sterile or none sterile (sterile before use) item that is intended to be used in operation room as a protective covering, for operating room staff, from the transferring of body fluids and particulates. Gowns provided as sterile and non-sterile. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

Device Story

Jincheng Surgical Gowns are single-use, open-back protective garments for operating room staff. Constructed from nonwoven fabrics (SMS polypropylene, Spunlace, or SFT) with raglan sleeves, hook-and-loop neck closures, and tie waist closures. Available in regular and reinforced styles, with or without guiders. Devices are provided either sterile or non-sterile; non-sterile versions are intended for OEM EtO sterilization per ISO 11135. Gowns act as a physical barrier to reduce cross-contamination between staff and patients by blocking body fluids and particulates. Used in clinical operating room environments; worn by surgical staff. Output is the physical barrier provided by the garment during surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing including biocompatibility (cytotoxicity, skin irritation, sensitization), hydrostatic pressure, impact penetration, breaking strength, flammability, and lint generation testing per consensus standards.

Technological Characteristics

Nonwoven fabric construction (SMS polypropylene, Spunlace, SFT). Design features: raglan sleeves, hook/loop neck, tie waist. Sizes: M, L, XL, XXL. Sterilization: EtO per ISO 11135. Performance standards: AATCC 127 (hydrostatic pressure), AATCC 42 (impact penetration), ASTM D5034 (breaking strength), 16 CFR 1610 (flammability), ISO 9073-10 (lint), ISO 10993-5/10 (biocompatibility).

Indications for Use

Indicated for use as a protective covering for operating room staff to prevent the transfer of body fluids and particulates. Available in sizes M, L, XL, and XXL.

Regulatory Classification

Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Predicate Devices

• International Medsurp Connection Surgical Gowns (IMC Gowns) (K052550)
• Welmed Surgical Gowns (K070431)

Submission Summary (Full Text)

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K102692

Section 5: 510k Summary

# MAR 1 1 2011

# Section 5: 510(k) Summary:

This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92

#### Submitter & Foreign Manufacture Identification

Hangzhou Jincheng Medical Supplier Manufacture Co., Ltd 202 Zhangshan Road, Renhe Town, Yuhang District Hangzhou, Zhejiang Province, China 311107 Tel: [phone] EXT 8205 Submitter's FDA Registration Number: N/A

#### US Agent and Contact Person

Chengyu Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: [phone] Email: [e-mail]

Date of Summary: June 22, 2010

Name of Device: Surgical Gown Classification Name: Gown, Surgical Product Code: FYA Regulation Number: 807.4040

#### Predicate Device Information:

- (1) K052550, "International Medsurp Connection Surgical Gowns (IMC Gowns)", manufactured by "International Medsurp Connection Surgical Gown Inc" located in Schaumburg, Illinois.
- (2) K070431, Welmed Surgical Gowns, manufactured by Welmed, Inc. located in Grayslake, Illinois.

#### Device description:

The Jincheng Surgical Gowns are an open back gown manufactured from nonwoven fabric that the fibres are mechanically bonded together. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They come with three different types of materials (SMS polypropylene fabric, Spunlace fabric, and SFT fabric) and four different design styles (regular, reinforced, regular with guider, and

Section 5: 510k Summary Section 5 p 1

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K102692

Section 5: 510k Summary

reinforced with guider). Therefore there are total eight different models involved in this submission. They are:

#### Jincheng SMS Gowns

- . SMS Reinforced Gown
- . SMS Reinforced Gown with Guider

#### Jincheng Spunlace Gowns

- Spunlace Regular Gown .
- Spunlace Regular Gown with Guider .
- . Spunlace Reinforced Gown
- Spunlace Reinforced Gown with Guider .

#### Jincheng SFT Gowns

- . SFT Gown
- SFT Gown with Guider .

Each design has four different sizes: Medium (M), Large (L), Extra Large (XL), and Extra Extra Large (XXL).

All gowns come with sterile and non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

#### Intended Use:

The Jincheng Surgical Gown is a single use, sterile or none sterile (sterile before use) item that is intended to be used in operation room as a protective covering, for operating room staff, from the transferring of body fluids and particulates.

Gowns provided as sterile and non-sterile.

Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

#### Comparison to Predicate Devices

Hangzhou Jincheng Surgical Gowns are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.

- (1) K052550, "International Medsurp Connection Surgical Gowns (IMC Gowns)", manufactured by "International Medsurp Connection Surgical Gown Inc" located in Schaumburg, Illinois.
- (2) K070431, Welmed Surgical Gowns, manufactured by Welmed, Inc. located in Grayslake, Illinois.

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Section 5: 510k Summary

The following table shows similarities and differences of use, design, and material between our device and the predicate devices.

| Description | Our Device | Predicate Device 1<br>(K070431) | Predicate Device 2<br>(K052550) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------|----------------------------------------------|
| Indication for<br>Use | Are used as protective<br>covering for operating room<br>staff, from the transferring of<br>body fluids and particulates. | Same | Same |
| Basic Design | Full length, constructed with<br>raglan sleeves, neck closures,<br>and waist closures. | Same | Same |
| Additional<br>Features | Regular and reinforced | Information not available | Regular and reinforced |
| Materials/size | Non-woven (SMS, Spunlace,<br>SFT)/various size | Non-woven (SMS,<br>SPP)/various size | Non-woven (various<br>material)/various size |
| Single Use | Yes | Yes | Information not available |
| Sterile | Both sterile and non sterile | Both sterile and non sterile | Information not available |

i

# Table 5.1: Comparison of Intended Use, Design, and Material

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Section 5: 510k Summary

The following table shows similarities and differences of the performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for Jincheng Surgical Gowns met all relevant requirements in the test standards, and are comparable to the predicate device.

Details of the test procedures and results can be found in Sections 15 (Biocompatibility) and 18 (Performance Testing-Bench).

| Description | Our Device | Predicate Device 1<br>(K070431) | Predicate Device 2<br>(K052550) |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Cytotoxicity | No Toxic Effect<br>(ISO10993-5) | No Toxic Effect<br>(ISO10993-5) | No Toxic Effect<br>(ISO10993-5) |
| Skin<br>Irritation and<br>Sensitization | No Effect<br>(ISO 10993-10) | No Effect<br>(ISO 10993-10) | No Effect<br>(ISO 10993-10) |
| Hydrostatic<br>Pressure:<br>Water<br>Resistance | AATCC Test Method 127: 1998:<br>Water Resistance: Hydrostatic<br>Pressure Test | Same | Same |
| Impact<br>Penetration<br>Test : Water<br>Resistance | AATCC 42: 2007: Water<br>Resistance: Impact Penetration<br>Test | Same | Same |
| Breaking<br>Strength | ASTM D5034: 2008: Standard<br>Test Method for Breaking<br>Strength and Elongation of<br>Textile Fabrics (Grab Test) | Same | Same |
| Elmedorf<br>Tear | In house method similar to<br>ASTM - D5734-95:2001 | ASTM - D5734-95:2001<br>Standard Test Method for<br>Tearing Strength of<br>Nonwoven Fabrics by<br>Falling-Pendulum<br>(Elmendorf) Apparatus | N/A |
| Flammability | 16 CFR 1610: Flammability Test<br>Method (CPSC CS-191-53)<br>Standard for Flammability of<br>Clothing Textiles | Same | Same |
| Lint | ISO 9073-10: Lint and Other<br>Particles Generation in the Dry<br>State | Same | IST 160.1 |

# Table 5.2: Comparison of Biocompatibility and Performance Testing

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Section 5: 510k Summary

More details of non-clinical tests are summarized in Section 15 and Section 18.

A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses:

Jincheng Surgical Gown meet requirements per AATCC Test Method 127: 1998. AATCC 42: 2007, ASTM D5034, 16 CFR 1610, ISO 9073-10, ISO 10993-5, and ISO 10993-10. It is safe and effective, and it's performance meets the requirements of its predefined acceptance criteria and intended uses.

A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

## Substantial Equivalent Statement

Based on the comparison of intended use, design, materials, and performance, our Jincheng Surgical Gowns are substantial equivalent to its predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Hangzhou Jincheng Medical Supplier Manufacture Company, Limited C/O Mr. Chengyu Shen Manton Business and Technology Services 5 Carcy Street Pennington, New Jersey 08534

MAR 1 1 2011

Re: K102692

Trade/Device Name: Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: February 17, 2011 Received: February 18, 2011

Dear Mr. Shen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Shen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that IFDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
James Rotch
for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital. Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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### Section 4: Indications for Use

| Material | Design | Sterilization | Model Name | Sizes |
|----------|------------------------|---------------|------------|---------------|
| SMS | Reinforced | Sterile | SG74100 | M, L, XL, XXL |
| | | Non-sterile | SG74700 | M, L, XL, XXL |
| SMS | Reinforced with Guider | Sterile | SG78100 | M, L, XL, XXL |
| | | Non-sterile | SG78700 | M, L, XL, XXL |
| Spunlace | Regular | Sterile | SG80100 | M, L, XL, XXL |
| | | Non-sterile | SG80700 | M, L, XL, XXL |
| Spunlace | Regular with Guider | Sterile | SG82100 | M, L, XL, XXL |
| | | Non-sterile | SG82700 | M, L, XL, XXL |
| Spunlace | Reinforced | Sterile | SG84100 | M, L, XL, XXL |
| | | Non-sterile | SG84700 | M, L, XL, XXL |
| Spunlace | Reinforced with Guider | Sterile | SG88100 | M, L, XL, XXL |
| | | Non-sterile | SG88700 | M, L, XL, XXL |
| SFT | Gown | Sterile | SG94100 | M, L, XL, XXL |
| | | Non-sterile | SG94700 | M, L, XL, XXL |
| SFT | Gown with Guider | Sterile | SG98100 | M, L, XL, XXL |
| | | Non-sterile | SG98700 | M, L, XL, XXL |

The gowns involved in this submission are summarized in the Table below:

Gowns provided as sterile and non-sterile.

Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

K102692

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div style="text-align:left">Elijah T. Clemmons Williams</div> |
|--|----------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Anesthesiology, General Hospital |
| | Infection Control, Dental Devices |

| 510(k) Number: | K102692 |
|----------------|---------|
|----------------|---------|

Section 4: Indication Section 4 page 2Section 4: Indication Section 4 page