SURGICAL GOWN, SMS

K121152 · Jiangsu Guangda Medical Material, Co., Ltd. · FYA · Dec 12, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121152
• Device Name: SURGICAL GOWN, SMS
• Applicant: Jiangsu Guangda Medical Material, Co., Ltd.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Dec 12, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Jiangsu Guangda's Reinforced Surgical Gowns, Model Number GD-SG-01, are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This product may be sterilized using Ethylene Oxide (EO) following the validation and routine control under ANSI/AAMI/ISO 11135.

Device Story

Disposable, reinforced surgical gown (Model GD-SG-01) designed for use in surgical settings to provide a barrier against microorganisms, body fluids, and particulates. Constructed from SMS fabric with a PE+PP two-layer compound reinforcement and 100% white Terylene cuffs. Device is provided non-sterile but is compatible with Ethylene Oxide (EO) sterilization per ANSI/AAMI/ISO 11135. Worn by operating room personnel to protect both the wearer and the patient during surgical procedures. Performance verified through bench testing for liquid barrier properties, tensile/tear/seam strength, and flammability.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-5, -10), liquid barrier performance (AATCC 127, AATCC 42, ASTM F1671, ASTM F1670), physical strength (ASTM D5034, D5733, D1683), and flammability (16 CFR 1610). All tests met acceptance criteria.

Technological Characteristics

Materials: SMS fabric and PE+PP two-layer compound; 100% Terylene cuffs. Form factor: XL size, blue color. Barrier performance: ANSI/AAMI PB70 compliant. Physical specs: ASTM D5034, D5733, D1683. Flammability: Class I (16 CFR 1610). Biocompatibility: ISO 10993-1, -5, -10. Sterilization: Compatible with EO (ANSI/AAMI/ISO 11135).

Indications for Use

Indicated for use as a single-use, non-sterile surgical gown to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. Suitable for use in surgical settings.

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

• GRI MEDICAL Surgical Gowns (K102652)

Submission Summary (Full Text)

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# K121152

# Section 5: 510(k) Summary

#### April 12, 2012 1. Preparation Date:

# DEC 1 2 2012

## 2. Submitted by:

Jiangsu Guangda Medical Material Co., Ltd. 18 BaoChang Road North, LiBao Town, Haian County, Jiangsu Province, China 226631 Owner/Operator #: 10023676 Registration Number: 3006847952

## 3. Contact Person/Prepared by:

Darren Reeves [phone] Phone: Fax: [phone] Email: [e-mail]

## 4. Device Identification:

Trade Name: Surgical Gown Common Name: Gown, Surgical Classification: Surgical Apparel, FYA, Class 2 (878.4040)

#### GRI MEDICAL Surgical Gowns (K102652) 5. Predicate Device:

#### 6. Device Description:

Jiangsu Guangda's Disposable XLarge Reinforced Surgical Gowns, Model Number GD-SG-01, are made from SMS fabrics and PE + PP two layer compound protective reinforcement with 100% white Terylene cuffs to provide user protection in surgical settings.

### 7. Intended Use:

Jiangsu Guangda's Reinforced Surgical Gowns, Model Number GD-SG-01, are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

This product may be sterilized using Ethylene Oxide (EO) following the validation and routine control under ANSI/AAMI/ISO 11135.

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#### 8. Comparison to Predicate:

The following table shows similarities and differences between the predicate identified in Section 5 of this summary. There are no significant differences between the Jiangsu Guangda's Gowns, Model Number GD-SG-01, and their respective predicate products.

| | Item | Proposed Device: Jiangsu Guangda's Gowns,<br>Model Number GD-SG-01 | Predicate Device: GRI MEDICAL<br>Surgical Gowns (K102652) |
|-----------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Product Code | FYA, Class II | FYA, Class II |
| | Intended Use | Jiangsu Guangda's Reinforced Surgical Gowns are<br>non-sterile, single use surgical gowns intended to<br>protect surgical patients and operating room<br>personnel from the transfer of microorganisms,<br>body fluids, and particulate material.<br>This product may be sterilized using Ethylene<br>Oxide (EO) following the validation and routine<br>control under ANSI/AAMI/ISO 11135. | GRI's Non Reinforced, Film Reinforced, and<br>Fabric Reinforced Surgical Gowns are<br>sterile and non-sterile, single use surgical<br>gowns intended to protect surgical patients<br>and operating room personnel from the<br>transfer of microorganisms, body fluids,<br>and particulate material. |
| | Style | Reinforced | Reinforced and non-reinforced |
| | Durability | Disposable | Disposable |
| | Size | XL | Various |
| | Color | Blue | Various |
| | Material | SMS and PE+PP two layer compound | Same |
| | Weight per square | 45 g/m² | 50 g/m² |
| | Label and Labeling | Conforms to FDA Requirements | Unknown |
| Liquid Barrier Performance:<br>ANSI/AAMI PB70 | Hydrostatic Pressure: AATCC<br>Test Method 127 | All were >20 | Has met acceptance criteria |
| | Impact Penetration: AATCC Test<br>Method 42 | All were ≤1 | Has met acceptance criteria |
| | Resistance by Blood-Borne<br>Pathogen: ASTM- F1671 | All were ≤1 | Unknown |
| | Resistance by Synthetic Blood:<br>ASTM- F1670 | Passed | Has met acceptance criteria |
| Physical Specifications | Breaking Strength: ASTM-<br>D5034 | Passed | Has met acceptance criteria |
| | Tearing Strength: ASTM- D5733 | Passed | Has met acceptance criteria |
| | Flammability Test Method (16<br>CFR 1610) | Class I | Has met acceptance criteria |
| | Seam Strength: ASTM- D1683 | Passed | Has met acceptance criteria |
| Biocompatibility:<br>ISO 10993-1 | Cytotoxicity: ISO 10993-5 | Passed | Has met acceptance criteria |
| | Irritation: ISO 10993-10 | Passed | Has met acceptance criteria |
| | Sensitization: ISO 10993-10 | Passed | Has met acceptance criteria |
| Sterilization | Method | Although sold non-sterile, gowns can be EO<br>Sterilized | Unknown |
| | EO and ECH Residual | Conforms to ISO 10993-7 | Unknown |

Jiangsu Guangda Medical Material Co., Ltd. Document Number K121152 S3.1

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#### 9. Summary of Testing:

The information in the Premarket Notification on safety and efficiency supports a finding of substantially equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, material, design and testing methods.

| Standard or Guidance | Data Generated | Relevant Section of<br>Submission |
|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------|
| ASTM-F2407-06 Standard Specification for Surgical Gowns intended for Use in Healthcare Facilities | Biocompatibility Testing Evaluation | 15 |
| AAMI/ANSI/ISO 10993-1:2003(E), Biological evaluation of<br>medical devices -- Part 1: Evaluation and testing | Biocompatibility Testing<br>Evaluation | 15 |
| AAMI/ANSI/ISO 10993-5:2009, Biological evaluation of medical<br>devices -- Part 5: Tests for In Vitro cytotoxicity | Cytotoxicity | 15 |
| AAMI/ANSI/ISO 10993-10:2010, Biological evaluation of<br>medical devices -- Part 10: Tests for irritation and sensitization | Skin Irritation, intra-<br>cutaneous reactivity &<br>sensitization | 15 |
| ANSI/AAMI PB70:2003, Liquid Barrier Performance and<br>Classification of protective apparel and drapes intended for use<br>in health care facilities | Barrier Performance | 18 |
| AATCC Test Method 127-2007&2008 Hydrostatic Pressure:<br>Option 2 | Water Resistance | 18 |
| AATCC Test Method 42-2007 Impact Penetration: Type II | Water Resistance | 18 |
| ASTM-F1671:2007 Standard Test Method for Resistance of<br>Materials Used in Protective Clothing to Penetration by Blood-<br>Borne Pathogens | Resistance to Penetration | 18 |
| ASTM-F1670:2008 Standard Test Method for Resistance of<br>Materials Used in Protective Clothing to Penetration by<br>Synthetic Blood | Resistance to Penetration | 18 |
| ASTM-D5034:1995 Standard Test Method for Breaking<br>Strength and Elongation of Textile Fabrics (Grab Test) | Tensile Strength | 18 |
| ASTM-D5733:1999 Standard Test Method for Tearing Strength<br>of Nonwoven Fabrics by Trapezoid Procedure | Tearing Strength | 18 |
| ASTM-D1683:2007 Standard Test Method for Failure in Sewn<br>Seams of Woven Apparel Fabrics | Seam Strength Test | 18 |
| CPSC CS-191-53 Flammability Test Method (16 CFR 1610)<br>Standard for Flammability of Clothing Textiles | Flammability | 18 |

#### Test Data Provided in this Submission

The predicate, GRI MEDICAL Surgical Gowns (K102652) met acceptance criteria for bench testing including biocompatibility, hydrostatic pressure, impact penetration, Resistance to Penetration by Synthetic Blood, flammability, and strength via tensile, tear and seam strength.

#### 10. Conclusion:

The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is is demonstrated through intended use, materials, design and testing methods.

11. Similarities/Differences of the proposed device when compared to the predicate: The data within this submission demonstrates that there are no significant differences between the application device and the predicate, indicating that the application device is safe, effective and substantially equivalent for marketing in the U.S.

Jiangsu Guangda Medical Material Co., Ltd. Document Number K121152 S3.1

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

#### December 12, 2012

Mr. Darren Reeves Jiangsu Guangda Medical Material Company, Limited 7305 Hancock Village Drive, Suite 109 CHESTERFIELD VA 23832

Re: K121152

Trade/Device Name: Jiangsu Guangda Surgical Gown, Model Number GD-SG-01 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: November 30, 2012 Received: December 4, 2012

Dear Mr. Reeves:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a reward your 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 conninered pror to May 20, 1977, in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmetic Act (110.) that to neviee, subject to the general controls provisions of the Act. The 1 ou may, therefore, market 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 addition. I lease noter a, 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 IT your device is blassified (been to be subjecting major regulations affecting your device can be may be subject to additions, 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. Reeves

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthong Dr. ant

Anthony D. Watson, B.A., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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**CENTER FOR DEVICES AND RADIOLOGICAL HEALTH**

K121157

# Indications for Use

510(k) Number (if known): K121152

Device Name: Jiangsu Guangda Surgical Gown, Model Number GD-SG-01

Indications for Use:

Jiangsu Guangda's Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

This product may be sterilized using Ethylene Oxide (EO) following the validation and routine control under ANSI/AAMI/ISO 11135.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Claverie
2012.12.11 18:08:11 -05'00'

General Hospital Anesthesfolog Infection Control, Denta

**510(k) Number:** K121152