SURGICAL GOWN

K141467 · Xuchang Zhengde Environstar Medical Products Co.,L · FYA · Mar 5, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K141467
• Device Name: SURGICAL GOWN
• Applicant: Xuchang Zhengde Environstar Medical Products Co.,L
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Mar 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Surgical gowns 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.

Device Story

Surgical gown; worn by operating room personnel during surgical procedures; provides barrier protection against microorganisms, body fluids, and particulate material. Constructed from soft, air-permeable SMS non-woven fabric. Available in standard and reinforced models. Reinforced areas utilize air-permeable membrane composite (PE + PP) and double-barrier non-woven fabric. Disposable; EO sterilized. Protects both patient and staff; reduces cross-contamination risk.

Clinical Evidence

Bench testing only. Testing included hydrostatic pressure (AATCC 127), impact penetration (AATCC 42), tensile strength (ASTM D 5034), tearing strength (ASTM D 5733), seam strength (ASTM D 1683), flammability (16 CFR Part 1610), and biocompatibility (irritation, sensitization, cytotoxicity).

Technological Characteristics

Materials: SMS non-woven fabric; reinforced areas use PE+PP composite. Standards: AATCC 127, AATCC 42, ASTM D 5034, ASTM D 5733, ASTM D 1683, 16 CFR Part 1610. Sterilization: Ethylene Oxide (EO). Form factor: Disposable surgical gown (standard/reinforced).

Indications for Use

Indicated for operating room personnel during surgical procedures to protect patient and personnel from transfer of 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.

Predicate Devices

• Jiangsu Guangda Surgical Gown (K121152)
• GRI's Surgical Gowns (K102652)

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

March 5, 2015

XuChang ZhengDe Environstar Medical Products Co., Ltd. c/o Mr. Mike Gu Regulatory Affairs Manager Osmunda Medical Device Consulting Co., Ltd. 7th Floor Jingui Business Building No. 982 Congyun Rd Baiyun District Guangzhou, Guangdong 510420 CHINA

Re: K141467

Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: February 6, 2015 Received: February 9, 2015

Dear Mr. Gu:

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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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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division 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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# Indications for Use

510(k) Number (if known) K141467

Device Name Surgical Gown

Indications for Use (Describe)

Surgical gowns 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.

Models:

- Standard surgical gown, model number: ZD2514, ZD2515, ZD2517, ZD2519 and ZD2520;
- Reinforced surgical gown, model number: ZD2544, ZD2547, ZD2547, ZD2549 and ZD2550.

Type of Use (Select one or both, as applicable)

- Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

# FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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### 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: 1. SUBMITTER

XuChang ZhengDe Environstar Medical Products Co.,Ltd

NO.3,Jinshui Road, Jinhui District, Yanling County, Xuchang City, 461200, Henan Prov., China

Phone: [phone]

Fax: [phone]

Mike Gu Primary Contact Person:

Regulatory Affairs Manager

OSMUNDA Medical Device Consulting Co., Ltd

Tel: [phone]

Fax: [phone]

Chen Ming Secondary Contact Person:

Quality Director

February 26, 2015

XuChang ZhengDe Environstar Medical Products Co., Ltd

Date Prepared:

11. DEVICE

Surgical Gown Name of Device:

Gown, Surgical Common/Usual Name:

Classification Names: Surgical apparel (21 CFR878.4040)

FYA

==

Regulation Class:

Product Code:

III. PREDICATE DEVICE

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Jiangsu Guangda Surgical Gown, Jiangsu Guangda Medical Material Co., Ltd, K121152.

GRI's Surgical Gowns, GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD, K102652.

These predicates have not been subject to a design-related recall.

No reference devices were used in this submission.

### IV. DEVICE DESCRIPTION

The surgical gown is 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. It is made of soft, air permeable SMS non-woven fabric.

### V. INDICATIONS FOR USE

Surgical gown 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.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

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| Specification | Predicate Device | Predicate Device | Proposed |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K121152 | K102652 | |
| Manufacturer | Jiangsu Guangda Medical<br>Material Co., Ltd. | GRI MEDICAL & ELECTRONIC<br>TECHNOLOGY CO., LTD | XuChang ZhengDe Environstar<br>Medical Products Co., Ltd |
| Intended Use | Jiangsu Guangda's Reinforced<br>Surgical Gowns, Model Number<br>GD-SG-01,<br>are non-sterile,<br>single<br>use<br>surgical gowns<br>intended to protect surgical<br>patients and operating room<br>personnel from the transfer of<br>microorganisms, body fluids,<br>and particulate material. | GRI's<br>Non Reinforced,<br>Reinforced, and Fabric Reinforced<br>Surgical Gowns are sterile or non-<br>sterile, single use surgical gowns<br>intended to protect surgical patients<br>and operating room personnel from<br>the transfer of microorganisms, body<br>fluids, and particulate material. | Surgical gown are devices that<br>are intended to be worn by<br>operating room personnel<br>during surgical procedures to<br>protect both the surgical<br>patient and the operating<br>room personnel from transfer<br>of microorganisms, body<br>fluids, and particulate<br>material. |
| Material | SMS | SMS | SMS |
| Weight per square (g) | 45 | 50 | 45 |
| Durability | Disposable | Disposable | Disposable |
| Size | XL | S, M, L, XL, XXL | M-S, M, L, XL, XXL |

ra

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| Color | Blue | Various | Blue |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reinforced area | PE + PP two layer<br>compound protective<br>reinforcement with 100%<br>white Terylene cuffs | polypropylene/polyethylene<br>protective<br>reinforcement | air permeable membrane<br>composite PE+ PP, double<br>barrier non-woven fabric |
| Style | Reinforced | Reinforced and non reinforced | Reinforced and non reinforced |
| Hydrostatic pressure:<br>AATCC 127 | >20 cm | Met acceptance criteria | >50 cm |
| Impact penetration:<br>AATCC 42 | ≤1 | Met acceptance criteria | ≤1 |
| Biocompatibility | under the conditions of the<br>study, not an irritant;<br>under conditions of the study,<br>not a sensitizer;<br>under the conditions of the<br>study the device is non-<br>cytotoxic. | under the conditions of the study,<br>not an irritant;<br>under conditions of the study, not a<br>sensitizer;<br>under the conditions of the study<br>the device is non-cytotoxic. | under the conditions of the<br>study, not an irritant;<br>under conditions of the study,<br>not a sensitizer;<br>Under the conditions of the<br>study the device is non-<br>cytotoxic. |
| Tensile strength: ASTM<br>D 5034 | Length(Ibf): 17.2<br>Width(Ibf): 25.3 | Met acceptance criteria | Length(Ibf): 17.7<br>Width(Ibf): 25.7 |

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| Tearing strength: ASTM<br>D 5733 | Length yarns torn(lbf): 4.5<br>Width yarns torn(lbf): 9.6 | Met acceptance criteria | Length yarns torn(lbf): 4.7<br>Width yarns torn(lbf): 9.8 |
|-----------------------------------------------|----------------------------------------------------------------|-------------------------|----------------------------------------------------------------|
| Seam strength: ASTM D<br>1683 | Armhole seam (lbf) 17.4(F.B.)<br>Shoulder seam (lbf) 9.4(F.B.) | Met acceptance criteria | Armhole seam (lbf) 17.6(F.B.)<br>Shoulder seam (lbf) 9.5(F.B.) |
| Flammability:<br>16 CFR Part 1610 | Class 1 | Met acceptance criteria | Class 1 |
| Sterilization method | EO | EO | EO |
| Resistance to blood and<br>liquid penetration | Level 4 per AAMI PB70 | Level 4 per AAMI PB70 | Level 3 per AAMI PB70 |

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The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device.

Therefore, the subject device is determined as safe and effectiveness.

### VII. CONCLUSIONS

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XuChang ZhengDe Environstar Medical Products Co.,Ltd considers the Surgical Gown to be as safe, and as effective as the predicate devices. It does not raise any new issues of safety or effectiveness.