ATEK SURGICAL GOWNS

K100971 · Hangzhou Atek Medical & Textile Co., Ltd. · FYA · Sep 27, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100971
• Device Name: ATEK SURGICAL GOWNS
• Applicant: Hangzhou Atek Medical & Textile Co., Ltd.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Sep 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material. Gowns provided as sterile and non-sterile. Non-sterile surgical gowns are to be sold to OEMs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtO cycle validated to ISO 11135 standard.

Device Story

Disposable surgical gowns manufactured from non-woven fabrics (SMS, Hydro-Entangled/Spunlance, SFT). Used by operating room personnel during surgical procedures to provide a barrier against body fluids and particulate matter. Gowns are available in reinforced and non-reinforced styles, with or without guider, in sizes L, XL, and XXL. Provided as either sterile or non-sterile; non-sterile versions intended for OEM sale for subsequent EtO sterilization. Sterile versions sterilized via validated EtO cycle. Device functions as physical protective apparel; no electronic or software components.

Clinical Evidence

Bench testing only. Performance data includes flammability (CPSC 16 CFR 1610), lint generation (ISO 9073-10), tensile strength (ASTM D5034), tear strength (ASTM D5734), and water resistance (AATCC 127, AATCC 42). Biocompatibility testing conducted per ISO 10993 series (cytotoxicity, irritation, sensitization). Sterilization validated per ISO 11135.

Technological Characteristics

Materials: SMS, Hydro-Entangled (Spunlance), SFT non-woven fabrics. Sterilization: Ethylene Oxide (EtO) per ISO 11135. Performance standards: AATCC 127 (hydrostatic pressure), AATCC 42 (spray impact), ASTM D5034 (tensile strength), ASTM D5734 (tear strength), ISO 9073-10 (lint), CPSC 16 CFR 1610 (flammability). Biocompatibility: ISO 10993-1, 5, 7, 10, 11.

Indications for Use

Indicated for use by operating room personnel during surgical procedures to protect patients and personnel from transfer of 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

• IMC Surgical Gowns (K052550)
• Master & Frank Surgical Gowns (Sterile) (K012186)

Submission Summary (Full Text)

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### 510(k) Summary Section 5:

#### 1.0 Submitted By:

SEP 27 2010

Gary Zhu, President

Hangzhou ATek Medical and Textile Co. Ltd.

Suite No. 503

Xi Xia Yuan No. 514

Hangzhou 310006

Zhe Chiang Province, China

Establishment Registration Number: 9615944

Primary Contact:

Glen Feye, President

Accurate Consultants, Inc. ·

1340 West Pennsylvania Ave.

San Diego, CA 92103

Telephone: [phone]/ Fax: [phone]

[e-mail]

#### September 22, 2010 2.0 Date Submitted:

#### 3.0 Device Name(s):

- Proprietary Names 3.1

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| MATERIAL | GOWN STYLE | STERILE/NON | Sizes | Model number |
|------------------------------------|-------------------------------|-------------|----------|--------------|
| SMS | Reinforced | Non Sterile | L/XL/XXL | AKSG74100 |
| | Reinforced | Sterile | L/XL/XXL | AKSG74700 |
| | Reinforced<br>with Guider | Non Sterile | L/XL/XXL | AKSG78100 |
| | Reinforced<br>with Guider | Sterile | L/XL/XXL | AKSG78700 |
| HYDRO-<br>ENTANGLED<br>(Spunlance) | Non-reinforced | Non Sterile | L/XL/XXL | AKSG80100 |
| | Non-reinforced | Sterile | L/XL/XXL | AKSG80700 |
| | Non-reinforced<br>with guider | Non Sterile | L/XL/XXL | AKSG82100 |
| | Non-reinforced<br>with guider | Sterile | L/XL/XXL | AKSG82700 |
| | Reinforced | Non Sterile | L/XL/XXL | AKSG84100 |
| | Reinforced | Sterile | L/XL/XXL | AKSG84700 |
| | Reinforced<br>with Guider | Non Sterile | L/XL/XXL | AKSG88100 |
| | Reinforced<br>with Guider | Sterile | L/XL/XXL | AKSG88700 |
| SFT | Reinforced | Non Sterile | L/XL/XXL | AKSG94100 |
| | Reinforced | Sterile | L/XL/XXL | AKSG94700 |
| | Reinforced<br>with Guider | Non Sterile | L/XL/XXL | AKSG98100 |
| | Reinforced<br>with Guider | Sterile | L/XL/XXL | AKSG98700 |

Hangzhou ATek Medical &Textile Surgical Gowns, Various

#### Common Name 3.2

Surgical Gown

Product code - FYA (Gown, Surgical)

#### 3.3 Classification Name

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Gown, Surgical (21CFR 878.4040 Product code - FYA )

#### 4.0 Predicate Devices:

| Candidate | Predicate | Manufacturer | Docket Number |
|-----------------------------------------------------------|-----------------------------------------------|--------------------------------------------|---------------|
| Hangzhou ATek<br>Medical and<br>Textile Surgical<br>Gowns | IMC Surgical<br>Gowns | International Medsurg<br>Connections, Inc. | K052550 |
| | Master & Frank<br>Surgical Gowns<br>(Sterile) | Master and Frank<br>Enterprises, Co. LTD | K012186 |

#### 5.0 Intended Use:

Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material.

Gowns provided as sterile and non-sterile.

Non-sterile surgical gowns are to be sold to OEMs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtO cycle validated to ISO 11135 standard.

The following disposable surgical gown types and model numbers are included in this submission

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| MATERIAL | GOWN STYLE | STERILE/NON | Sizes | Model number |
|------------------------------------|-------------------------------|-------------|----------|--------------|
| SMS | Reinforced | Non Sterile | L/XL/XXL | AKSG74100 |
| | Reinforced | Sterile | L/XL/XXL | AKSG74700 |
| | Reinforced<br>with Guider | Non Sterile | L/XL/XXL | AKSG78100 |
| | Reinforced<br>with Guider | Sterile | L/XL/XXL | AKSG78700 |
| HYDRO-<br>ENTANGLED<br>(Spunlance) | Non-reinforced | Non Sterile | L/XL/XXL | AKSG80100 |
| | Non-reinforced | Sterile | L/XL/XXL | AKSG80700 |
| | Non-reinforced<br>with Guider | Non Sterile | L/XL/XXL | AKSG82100 |
| | Non-reinforced<br>with Guider | Sterile | L/XL/XXL | AKSG82700 |
| | Reinforced | Non Sterile | L/XL/XXL | AKSG84100 |
| | Reinforced | Sterile | L/XL/XXL | AKSG84700 |
| SFT | Reinforced<br>with Guider | Non Sterile | L/XL/XXL | AKSG88100 |
| | Reinforced<br>with Guider | Sterile | L/XL/XXL | AKSG88700 |
| | Reinforced | Non Sterile | L/XL/XXL | AKSG94100 |
| | Reinforced | Sterile | L/XL/XXL | AKSG94700 |
| | Reinforced<br>with Guider | Non Sterile | L/XL/XXL | AKSG98100 |
| | Reinforced<br>with Guider | Sterile | L/XL/XXL | AKSG98700 |

#### 6.0 Comparison to Predicate(s):

The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.

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| Aspect/<br>Characteristic | Predicate Gowns | IMC Gowns<br>K052550 | Master Frank Gowns<br>K012186 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For<br>Use | Disposable gowns are<br>worn by operating room<br>personnel during<br>surgical procedures to<br>protect both the<br>surgical patient and OR<br>personnel from the<br>transfer of body fluids<br>and particulate<br>material.<br><br>Gowns provided as<br>sterile and non-sterile. | Surgical Gown is<br>intended to be used<br>as patient<br>protective<br>coverings used to<br>isolate incision sites<br>and protect against<br>contamination<br>during surgical<br>procedures.<br><br>Gowns provided as<br>sterile and non-<br>sterile | Single Use article of<br>surgical apparel worn<br>by operator room<br>personnel during<br>surgical procedures to<br>protect both the<br>surgical patient and<br>the operating room<br>personnel from<br>transfer of<br>microorganisms, body<br>fluids, particulate<br>material.<br><br>Sterile Surgical<br>Gowns only |
| Class | 2 | 2 | 2 |
| Product Code | FYA | FYA | FYA |
| Device<br>Description | Disposable Gowns<br>manufactured from non-<br>woven fabric. Various<br>sizes and materials. | Disposable Gowns<br>manufactured from<br>non-woven fabric.<br>Various sizes and<br>materials. | Disposable Gowns<br>manufactured from<br>non-woven fabric.<br>Various sizes and<br>materials. |
| Model Numbers | Various | Various | Various |
| Material<br>Characteristics | SMS/Hydro-Entangled<br>(Spunlace), SFT | Multiple SMS and<br>SPP (Spunlace) | SFT |
| Performance<br>Testing | Flammability- CPSC 16<br>CFR 1610<br>Lint ISO 9073-10:2003<br>Tensile Strength- ASTM<br>D5034 | Flammability-<br>CPSC 16 CFR 1610<br>Lint ISO 9073-<br>10:2003<br>Tensile Strength-<br>ASTM D5034 | Flammability- 16 CFR<br>Part 10<br>Lint IST 160.1<br>Tensile Strength-<br>ASTM D5034 |
| Performance<br>Standards Used | AATCC 127<br>AATCC 42 | AATCC 127<br>AATCC 42 | AATCC 127<br>AATCC 42 |
| Biocompatibility<br>Standards Used | ISO 10933-5<br>ISO 10933-10 | ISO 10933-5<br>ISO 10933-10 | ISO 10933-5<br>ISO 10933-10<br>ISO 10933-11 |

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#### 7.0 Summary of Performance Data:

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

| Standard or Guidance Document | Data Generated | Relevant<br>Section of<br>Submission |
|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------|
| AAMI/ANSI/ISO 11135-1 2007, Medical<br>Devices -Validation and Routine Control of<br>Ethylene Oxide<br>Sterilization | EtO Sterlization<br>Validation<br>Parameters | 14 |
| AAMI / ANSI / ISO 10993-7:1995, Biological<br>evaluation of medical devices -- Part 7: EO<br>Residual Determination | EO Residuals | 14 |
| AAMI / ANSI / ISO 10993-1:2003(E),<br>Biological evaluation of medical devices --<br>Part 1: Evaluation and testing | Biocompatibility<br>Testing Evaluation | 15 |
| AAMI / ANSI / ISO 10993-5: (1999 and<br>2009) Biological evaluation of medical<br>devices -- Part 5: Tests for In Vitro<br>cytotoxicity | Cytotoxicity | 15 |
| AAMI / ANSI / ISO 10993-10:2002/Amd.<br>1:2006, Biological evaluation of medical<br>devices -- Part 10: Tests for irritation and<br>sensitization | Skin Irritation, intra-<br>cutaneous<br>reactivity &<br>sensitization | 15 |
| AATCC Test Method 127-2008<br>Water Resistance: Hydrostatic Pressure<br>Test | Hydrostatic<br>Pressure - Water<br>Resistance | 18 |
| AATCC Test Method 42-2007<br>Water Resistance: Spray Impact<br>Penetration Test | Impact Penetration<br>- Water Resistance | 18 |
| ASTM - D5034-2008 Standard Test Method<br>for Breaking Strength and Elongation of<br>Textile Fabrics (Grab Test) | Tensile Strength | 18 |

## Test Data Provided in this Submission

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| Standard or Guidance Document | Data Generated | Relevant<br>Section of<br>Submission |
|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--------------------------------------|
| ASTM -- D5734-1995(2001) Standard Test<br>Method for Tearing Strength of Nonwoven<br>Fabrics by Falling-Pendulum (Elmendorf)<br>Apparatus | Elmendorf Tear | 18 |
| ISO 9073-10:2003 - Textiles -- Test<br>methods for nonwovens -- Part 10: Lint and<br>other particles generation in the dry state | Gelbo Flex - Lint | 18 |
| CPSC 16 CFR 1610-2004 Standard for<br>Flammability of Clothing Textiles | Flammability | 18 |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus. The overall design is simple and monochromatic.

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

Hangzhou Atek Medical & Textile Company, Limited C/O Mr. Glen Feye Accurate Consultants Incorporated 1340 West Pennsylvania Avenue San Diego, California 92103

SEP 2 7 2010

Re: K100971

Trade/Device Name: Hangzhou ATek Medical & Textile Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: September 10, 2010 Received: September 13, 2010

Dear Mr. Feye:

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. Feye

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/CDRHQffices/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,

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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ATTACHAGA

#### K110971 Section 4: Indications for Use Statements

## Indications for Use

SEP 27 2010

510(k) Number (if known): K100971

Device Name: Hangzhou ATek Medical &Textile Surgical Gowns

Indications for Use:

Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material.

Gowns provided as sterile and non-sterile.

Non-sterile surgical gowns are to be sold to OEMs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtO cycle validated to ISO 11135 standard.

The following disposable surgical gown types and model numbers are included in this submission

{10}------------------------------------------------

| MATERIAL | GOWN STYLE | STERILE/NON | Sizes | Model number |
|------------------------------------|-------------------------------|-------------|----------|--------------|
| SMS | Reinforced | Non Sterile | L/XL/XXL | AKSG74100 |
| | Reinforced | Sterile | L/XL/XXL | AKSG74700 |
| | Reinforced<br>with Guider | Non Sterile | L/XL/XXL | AKSG78100 |
| | Reinforced<br>with Guider | Sterile | L/XL/XXL | AKSG78700 |
| HYDRO-<br>ENTANGLED<br>(Spunlance) | Non-reinforced | Non Sterile | L/XL/XXL | AKSG80100 |
| | Non-reinforced | Sterile | L/XL/XXL | AKSG80700 |
| | Non-reinforced<br>with guider | Non Sterile | L/XL/XXL | AKSG82100 |
| | Non-reinforced<br>with guider | Sterile | L/XL/XXL | AKSG82700 |
| | Reinforced | Non Sterile | L/XL/XXL | AKSG84100 |
| | Reinforced | Sterile | L/XL/XXL | AKSG84700 |
| | Reinforced<br>with Guider | Non Sterile | L/XL/XXL | AKSG88100 |
| | Reinforced<br>with Guider | Sterile | L/XL/XXL | AKSG88700 |
| SFT | Reinforced | Non Sterile | L/XL/XXL | AKSG94100 |
| | Reinforced | Sterile | L/XL/XXL | AKSG94700 |
| | Reinforced<br>with Guider | Non Sterile | L/XL/XXL | AKSG98100 |
| | Reinforced<br>with Guider | Sterile | L/XL/XXL | AKSG98700 |

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Clarence-Williams

(Division Sign-Off) (Division of Anesthesiology, General Hospital
Infection of Anesthesiology, General Devices

510(k) Number: K 1 O O 9 21 --------------------------------------------------------------------------------------------------------------------------------------------------