SURGICAL GOWN

K141606 · Cobes Industries Co., Ltd. · FYA · Nov 17, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141606
• Device Name: SURGICAL GOWN
• Applicant: Cobes Industries Co., Ltd.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Nov 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Surgical Gowns 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.

Device Story

Surgical gowns worn by operating room personnel; provide barrier protection against microorganisms, body fluids, and particulate material during surgical procedures. Device consists of various models (21, 22, 23, 24 series) constructed from SMS or SFS non-woven fabrics. Available in multiple sizes (Large to XXXXX-Large) and reinforcement configurations, including non-reinforced, fabric-reinforced, poly-reinforced, and breathable trilaminate sleeves. Gowns function as physical barriers to prevent cross-contamination between patient and staff. Used in clinical operating room environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: SMS (35gsm, 47gsm, 47gsm soft) and SFS (68gsm) non-woven fabrics. Configurations: Non-reinforced, fabric-reinforced, poly-reinforced, and breathable trilaminate sleeves. Form factor: Surgical gown. Regulatory class: II. Product code: FYA.

Indications for Use

Indicated for operating room personnel during surgical procedures to provide barrier protection against microorganisms, body fluids, and particulate material.

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.

Submission Summary (Full Text)

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

November 17,2014

Cobes Industries Company Limited C/O Ms. Lynn Fu Shenzhen Rendermed Consulting Company Limited 23 Dengliang Road, Hanking Center 7E-011 Shenzhen, Gguangdong 518052 CHINA

Re: K141606

Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: October 11, 2014 Received: October 17, 2014

## Dear Ms. Fu:

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 - Ms. Fu

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K141606

Device Name

Surgical Gown

Indications for Use (Describe)

Surgical Gowns 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## Product Models are provided below:

| Model Category | Model | Size | Reinforced method | Material |
|-------------------|-------|-------------|----------------------------------------------------|----------------|
| 21Series | 21001 | Large | | SMS-35gsm |
| | 21002 | X-Large | Non-Reinforced | |
| | 21003 | XX-Large | | |
| | 21004 | XXX-Large | | |
| | 21101 | Large | Fabric Reinforced | |
| | 21102 | X-Large | | |
| | 21103 | XX-Large | | |
| | 21201 | Large | Poly-Reinforced | |
| | 21202 | X-Large | | |
| | 21203 | XX-Large | | |
| | 21204 | XXX-Large | | |
| | 21205 | XXXX-Large | | |
| | 21206 | XXXXX-Large | | |
| | 21301 | Large | Poly-Reinforced,<br>Breathable Trilaminate Sleeves | |
| | 21302 | X-Large | | |
| | 21303 | XX-Large | | |
| | 21304 | XXX-Large | | |
| 22Series | 22001 | Large | | SMS-47gsm |
| | 22002 | X-Large | Non-Reinforced | |
| | 22003 | XX-Large | | |
| | 22004 | XXX-Large | | |
| | 22005 | XXXX-Large | | |
| | 22101 | Large | Fabric Reinforced | |
| | 22102 | X-Large | | |
| | 22103 | XX-Large | | |
| | 22201 | Large | Poly-Reinforced | |
| | 22202 | X-Large | | |
| | 22203 | XX-Large | | |
| | 22204 | XXX-Large | | |
| | 22205 | XXXX-Large | | |
| | 22301 | Large | Poly-Reinforced,<br>Breathable Trilaminate Sleeves | |
| | 22302 | X-Large | | |
| | 22303 | XX-Large | | |
| 23Series | 23001 | Large | | SMS-47gsm soft |
| | 23002 | X-Large | Non-Reinforced | |
| | 23003 | XX-Large | | |
| | 23004 | XXX-Large | | |
| | 23101 | Large | Fabric Reinforced | |
| | 23102 | X-Large | | |
| | 23103 | XX-Large | | |
| | 23201 | Large | Poly-Reinforced | |
| | 23202 | X-Large | | |
| | 23203 | XX-Large | | |
| | 23204 | XXX-Large | | |
| | 23205 | XXXX-Large | | |
| | 23206 | XXXXX-Large | | |
| | 23301 | Large | Poly-Reinforced,<br>Breathable Trilaminate Sleeves | |
| | 23302 | X-Large | | |
| | 23303 | XX-Large | | |
| Model<br>Category | Model | Size | Reinforced method | Material |
| 24Series | 24001 | Large | Breathable Trilaminate Sleeves | SFS-68gsm |
| | 24002 | X-Large | | |
| | 24003 | XX-Large | | |
| | 24004 | XXX-Large | | |
| | 24005 | XXXX-Large | | |
| | 24006 | XXXXX-Large | | |

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| First code: | Second code | Third code | Fourth~Fifth code |
|-----------------|------------------|---------------------------------------------------|-------------------|
| 2-Surgical Gown | 1- SMS-35gsm | 0- Non-Reinforced | 01-Large |
| 2-Surgical Gown | 2- SMS-47gsm | 1- Fabric Reinforced | 02-X-Large |
| 2-Surgical Gown | 3-SMS-47gsm Soft | 2- Poly-Reinforced | 03- XX-Large |
| 2-Surgical Gown | 4- SFS-68gsm | 3-Poly-Reinforced, Breathable Trilaminate Sleeves | 04- XXX-Large |
| 2-Surgical Gown | 4- SFS-68gsm | 4- Non-Reinforced, Breathable Viral Barrier | 05-XXXX-Large |
| 2-Surgical Gown | 4- SFS-68gsm | 4- Non-Reinforced, Breathable Viral Barrier | 06-XXXXX-Large |