NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS

K102652 · Gri Medical & Electronic Technology Co., Ltd. · FYA · Feb 3, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K102652
• Device Name: NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS
• Applicant: Gri Medical & Electronic Technology Co., Ltd.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Feb 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

GRI's Non Reinforced, Film Reinforced, and Fabric Reinforced Surgical Gowns are sterile or 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.

Device Story

Surgical gowns constructed from SMS (spunbond-meltblown-spunbond) fabrics with optional polypropylene/polyethylene film or fabric reinforcement. Designed for use in surgical settings to protect patients and OR personnel from fluid and particulate transfer. Gowns are single-use, available in various sizes and reinforcement configurations. Non-reinforced gowns meet AAMI Level 2 barrier requirements; film and fabric-reinforced gowns meet AAMI Level 3 requirements. Device provides physical barrier protection; no electronic or software components.

Clinical Evidence

Bench testing only. Testing included biocompatibility, hydrostatic pressure, impact penetration, resistance to blood penetration, and physical strength (tensile, tear, seam strength).

Technological Characteristics

Materials: SMS fabric (polypropylene), polypropylene/polyethylene film reinforcement. Barrier levels: AAMI Level 2 (non-reinforced) and AAMI Level 3 (film/fabric reinforced). Single-use, sterile or non-sterile. No electronic components or software.

Indications for Use

Indicated for surgical patients and operating room personnel to provide a barrier against microorganisms, body fluids, and particulate material during surgical procedures. Available in sterile and non-sterile versions.

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

• Kimberly Clark KC 100 Surgical Gowns (K093115)
• Astound by Convertors Impervious Film Reinforced Surgical Gowns (K061308)
• Kimberly Clark Fabric Reinforced Surgical Gowns (K080795)

Submission Summary (Full Text)

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K102652

gri.
™

## 85. 510(k) Summary

## FEB - 3 20i1

GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. 5.1 Submitted by: 1805 HongGao Road, XiuZhou Industry Zone, ZheJiang, China. 314031 86-573-83916501 86-573-83916520

Penny Northcutt 5.2 Contact Person: REGSolutions, LLC. 717 Lakeglen Drive Suwanee, GA 30024 Fax: [phone] Phone: [phone] Email: [e-mail]

December 1, 2010 5.3 Summary Date:

- Gowns Surgical 5.4 Device Name:
5.5 Common/Usual Name: Surgical gown

General & Plastic Surgery 5.6 Device Classification:

Class II - 21 CFR 878.4040

- 5.7 Device Product Code: FYA
5.8 Device Description:

GRI's Non Reinforced, Film Reinforced and Fabric Reinforced Surgical Gowns are made from SMS fabrics and polypropylene/polyethylene protective reinforcement to provide user protection in surgical settings. The gowns are available in various designs and combinations of materials, sizes, and reinforcement configurations.

The Non Reinforced Surgical Gowns meet the requirements of AAMI Level 2 liquid barrier requirements.

The Fabric-Reinforced Surgical Gowns meet the requirements of AAMI Level 3 liquid barrier requirements.

The Film-Reinforced Surgical Gowns meet the requirements of AAMI Level 3 liquid barrier requirements.

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Image /page/1/Picture/0 description: The image shows the logo for GRI, which stands for Global Reporting Initiative. The logo is in black and features the lowercase letters "gri" in a stylized font. A curved line extends from the top of the "i", adding a distinctive element to the design. The letters are bold and slightly slanted, giving the logo a dynamic appearance.

| GRI Gowns | Predicate Gowns |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Group 1 – Non Reinforced Surgical Gowns<br>Product codes 90-10XX-S and 90-20XX-S | Kimberly Clark K093115<br>KC 100 Surgical Gowns<br>Product code 99284, 99285, 99294, 99295 |
| GRI Gowns Group 2<br>Film Reinforced Surgical Gowns<br>Product codes 90-12XX-S and 90-22XX-S | Astound by Convertors K061308<br>Impervious Film Reinforced Surgical<br>Gowns, Product code Cat. 9040 |
| GRI Gowns Group 3<br>Fabric Reinforced Surgical Gowns<br>Product codes 90-13XX-S and 90-24XX-S | Kimberly Clark K080795<br>Fabric Reinforced Surgical Gowns<br>Product code 95211 |

#### te Device Information and Substantial Equivalence:

GRI's Non Reinforced, Film Reinforced and Fabric Reinforced gowns are substantially equivalent to the above predicates in intended use statements, equivalent device construction, materials, gown design, and technology performance characteristics.

### 5.10 Indications for Use:

GRI's Non Reinforced, Film Reinforced, and Fabric Reinforced Surgical Gowns are sterile or 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.

### 5.11 Summary of Testing:

GRI Surgical Gowns have met acceptance criteria for bench testing including biocompatibility, hydrostatic pressure, impact penetration, Resistance to Penetration by bloodmpatibility, fly around ity, and strength via tensile, tear and seam strength.

### 5.12 Conclusion:

Based on the performance testing and device attributes, it can be concluded that the GRI surgical gowns are equivalent to the predicate devices with respect to the indications for use and technological characteristics and do not present any further safety or effectiveness questions.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three overlapping human figures, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the graphic. The text is in a sans-serif font and is black in color.

Public Health Service

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

GRI Medical & Electronic Technology Company, Limited C/O Ms. Penny Northcutt Regsolutions, LLC 717 Lakeglen Drive Suwanee. Georgia 30024

Re: K102652

FEB - 3 201

Trade/Device Name: Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Il Product Code: FYA Dated: January 19, 2011 Received: January 20, 2011

Dear Ms. Northcutt:

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. Northcutt

Enclosure

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/Safetv/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.hum.

Sincerely yours,

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

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# Indications for Use Form

### Indications for Use: Sterile products

510(k) Number (if known): K102652

Device Name: Surgical Gowns

GRI's Non Reinforced Surgical Gowns are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. GRI's Non Reinforced Surgical Gowns meet Level 2 of the AAMI Liquid Barrier classifications. See Page 4-2 for product list.

GRI's Film Reinforced Surgical Gowns are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. GRI's Film Reinforced Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications. See Page 4-2 for product list.

GRI's Fabric Reinforced Surgical Gowns are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. GRI's Fabric Reinforced Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications. See Page 4-2 for product list.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use . X (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)

Page 4-1 of 4-4

Eli, M.-м
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: K102652

Page 63 of 236

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| Indications for Use Product List: Sterile | | |
|--------------------------------------------|---------------|---------------------------------------------------|
| Product Name | Model Code | Primary Material |
| GRI Non-<br>Reinforced Surgical<br>gown | 90-10XX-S | 50gsm SMS in blue, Non-reinforced |
| GRI Non-<br>Reinforced Surgical<br>gown | 90-20XX-S | 35gsm SMS in blue, Non-reinforced |
| GRI Film-<br>Reinforced Surgical<br>gown | 90-12XX-S | 50gsm SMS in blue with film reinforcement |
| GRI Film-<br>Reinforced Surgical<br>gown | 90-22XX-S | 35gsm SMS in blue with film reinforcement |
| GRI Fabric-<br>Reinforced Surgical<br>gown | 90-13XX-S | 50gsm SMS in blue with 50gsm SMS<br>reinforcement |
| GRI Fabric-<br>Reinforced Surgical<br>gown | 90-24XX-S | 35gsm SMS in blue with 35gsm SMS<br>reinforcement |
| Key for Surgical Gown Codes: | | |
| | Prefix | 90= Surgical gown series |
| | Suffix - 1 | First position represents "fabric" |
| | | 1 = 50gsm SMS |
| | | 2 = 35gsm SMS |
| | Suffix - 2 | Second position represents "reinforcement" |
| | | 0 = None |
| | | 2 = Film reinforced |
| | | 3 = Fabric, 50gsm SMS |
| | | 4 = Fabric, 35gsm SMS |
| | Suffix - 3(x) | Third position represents "size" |
| | | 0 = Small |
| | | 1 = Medium |
| | | 2 = Large |
| | | 3 = Xlarge |
| | | 4 = XXLarge |
| | Suffix - 4(x) | Fourth position represents "length" |
| | | 0 = Standard |
| | | 1 = XLong |
| | Suffix - 5 | Fifth position represents "packaging" |
| | | S = Sterile |

## Indications for Use Product I ist· Sterile

: :

:

.

Page _4-2_ of _4-4

.

.

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## Indications for Use: Non-Sterile products

510(k) Number (if known): K102652

Device Name: Surgical Gowns

GRI's Non 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. GRI's Non Reinforced Surgical Gowns meet Level 2 of the AAMI Liquid Barrier classifications. See Page 4-4 for product list.

GRI's Film Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, process ourgiour paticulate material. GRI's Film Reinforced Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications. See Page 4-4 for product list.

GRI's Fabric Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, protoc. or group particulate material. GRI's Fabric Reinforced Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications. See Page 4-4 for product list.

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 R. Clamin-Will

Page 4-3 of 4-4

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K102652

{7}------------------------------------------------

| Product Name | Model Code | Primary Material |
|-------------------------------------|------------|---------------------------------------------------|
| GRI Non-Reinforced Surgical gown | 90-10XX | 50gsm SMS in blue, Non-reinforced |
| | 90-20XX | 35gsm SMS in blue, Non-reinforced |
| GRI Film-Reinforced Surgical gown | 90-12XX | 50gsm SMS in blue with film reinforcement |
| | 90-22XX | 35gsm SMS in blue with film reinforcement |
| GRI Fabric-Reinforced Surgical gown | 90-13XX | 50gsm SMS in blue with 50gsm SMS<br>reinforcement |
| | 90-24XX | 35gsm SMS in blue with 35gsm SMS<br>reinforcement |

## Indications for Use Product List: Non-Sterile

## Key for Surgical Gown Codes:

| Prefix | 90= Surgical gown series |
|---------------|--------------------------------------------|
| Suffix - 1 | First position represents "fabric" |
| | 1 = 50gsm SMS |
| | 2 = 35gsm SMS |
| Suffix - 2 | Second position represents "reinforcement" |
| | 0 = None |
| | 2 = Film reinforced |
| | 3 = Fabric, 50gsm SMS |
| | 4 = Fabric, 35gsm SMS |
| Suffix - 3(x) | Third position represents "size" |
| | 0 = Small |
| | 1 = Medium |
| | 2 = Large |
| | 3 = Xlarge |
| | 4 = XXLarge |
| Suffix - 4(x) | Fourth position represents "length" |
| | 0 = Standard |
| | 1 = XLong |