ComfortGuard Surgical Gown, i600, Film Reinforced
Device Facts
| Record ID | K163191 |
|---|---|
| Device Name | ComfortGuard Surgical Gown, i600, Film Reinforced |
| Applicant | Gri Medical & Electrical Technology Co., Ltd. |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Feb 27, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The ComfortGuard Surgical Gown, i600, Film Reinforced is a single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The ComfortGuard Surgical Gown, i600, Film Reinforced has been tested and is classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
Device Story
Single-use surgical gown; protects patients and OR personnel from microorganisms, body fluids, and particulates. Multi-layer construction (SMS and film lamination) in critical zones; single-layer SMS (polyolefin nonwoven) in non-critical zones and back panels. Features include neck binder, hook-and-loop tabs, belt ties, removable transfer accessory, and cuffs (optional thumb-hooks). Available in various sizes, including A-frame designs for sitting procedures. Used in healthcare facilities; worn by surgical staff. Provides AAMI Level 4 liquid barrier protection in critical zones. Performance verified via bench testing for liquid barrier, flammability, and biocompatibility.
Clinical Evidence
Bench testing only. Evaluated per AAMI PB70:2012 for liquid barrier performance (ASTM F1671-13 viral penetration, AATCC 42-2013 impact penetration), flammability (16 CFR Part 1610), and biocompatibility (ISO 10993-5, ISO 10993-10). Physical properties tested per ASTM D3776 (basis weight), ASTM D5034-09 (grab tensile), ASTM D5587 (trapezoid tear), and ASTM D1683 (seam strength). Results met all predetermined specifications.
Technological Characteristics
Multi-layer SMS and film lamination (critical zones); single-layer SMS polyolefin nonwoven (non-critical/back). Ethylene oxide sterilization. AAMI Level 4 barrier classification. Physical specs: ASTM D3776, D5034, D5587, D1683. Anti-static and alcohol-repellent additives. Sizes include standard and A-frame.
Indications for Use
Indicated for use as a single-use surgical gown to protect surgical patients and operating room personnel from the 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
- Kimberly-Clark ULTRA Film-Reinforced Surgical Gown (K080795)
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
February 27. 2017
Gri Medical & Electrical Technology Co., Ltd. % Harry Shaffer President Sterilization Consulting Services, LLC 10051 Oak Leaf Way Highlands Ranch, Colorado 80129
Re: K163191
Trade/Device Name: Comfortguard Surgical Gown, i600, Film Reinforced Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: January 20, 2017 Received: February 6, 2017
Dear Harry Shaffer:
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.
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Susan Runno DDS, MA
For Tina Kiang, Ph.D. Acting 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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# Indications for Use
510(k) Number (if known) K163191
Device Name
ComfortGuard Surgical Gown, i600, Film Reinforced
Indications for Use (Describe)
The ComfortGuard Surgical Gown, i600, Film Reinforced is a single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
The ComfortGuard Surgical Gown, i600, Film Reinforced has been tested and is classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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# SECTION C Summary
# 1 510(k) Summary
This 510(k) summary information is submitted in accordance with the requirements of 21 CFR 807.92.
| Date: | January 20th, 2017 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | GRI Medical & Electronic Technology Co., Ltd. |
| Contact: | Martin Paugh, V.P. of RA/QA<br>1805 HongGao Road<br>XiuZhou Industry Zone<br>JiaXing, ZheJiang, China, 314031<br>Tel: 86-135-1135-9722<br>Email: mpaugh@gri-china.com |
| Official Correspondent: | Harry Shaffer, President<br>Sterilization Consulting Services LLC<br>10051 Oak Leaf way, Highlands Ranch, CO 80129<br>Tel: 303-929-3808<br>Email: HShaffer@Sterilizationconsulting.com |
| Device Trade Name: | ComfortGuard Surgical Gown, i600, Film Reinforced |
| Common or Usual Name: | Surgical gown |
| Classification Name: | Surgical Apparel |
| Device Classification: | Class II per 21 CFR §878.4040<br>General and plastic surgery<br>Product Code: FYA |
| Predicate Device: | Kimberly-Clark ULTRA Film-Reinforced Surgical Gown(K080795) |
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#### Description of the Device 1.1
The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-51) consists of a multi-layer in the critical zones (SMS & Film Lamination), single layer of SMS (polyolefin nonwoven) in the noncritical zones in the body and sleeve, single layer of SMS (polyolefin nonwoven) in the back panel with a lower basis weight SMS.
The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) is provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight regular sizes and two special sizes (A-frame) available for each design in both sterile and nonsterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XXL-XLONG, XXL-XLONG, Aframe L-XLONG, A-frame XL-XLONG. The two special sizes (A-frame L-XLONG, A-frame XL-XLONG) have much wider bottom that are designed for sitting procedures. And the reinforcement still covers the critical zone as in the other product codes.
The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) has been tested according to AAMI PB70:2012 and met the AAMI Level 4 liquid barrier performance requirements. It is constructed with or without thumb-hooks in cuffs, with pleats in the back panels, with a lower basis weight SMS in the back panel. The addition of thumb-hooks, back pleats, and the use of a lighter basis weight material in the back panels does not impact the performance of the gown in accordance with AAMI PB70 requirement.
#### 1.2 Indications for Use
The ComfortGuard Surgical Gown, i600, Film Reinforced is a single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
The ComfortGuard Surgical Gown, i600, Film Reinforced has been tested and is classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
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Image /page/5/Picture/0 description: The image contains the logo for GRI, which stands for Global Resources International. The logo features the letters 'gri' in a bold, sans-serif font, with the 'i' having a curved line above it, resembling a check mark or a stylized accent. Below the letters, the words 'Global Resources International' are written in a smaller font size.
Product Codes covered in this submission 1.3
Table C 1 Product List
| Product List | | |
|---------------------------------------------------|-----------------------------------|--------------------------------|
| Product Name | Model Code without<br>Thumb-hooks | Model Code with<br>Thumb-hooks |
| ComfortGuard Surgical Gown, i600, Film Reinforced | i90-82xx-S1 | i90-82xxT-S1 |
| | i90-82xx | i90-82xxT |
#### Table C 2 Key for Surgical Gown Codes
| Key for Surgical Gown Codes: | |
|------------------------------|--------------------------------------------|
| Prefix | 90= Surgical gown with Set-In sleeve |
| Suffix - 1 | First position represents base "fabric" |
| | 8 = 47gsm SMS |
| Suffix - 2 | Second position represents "reinforcement" |
| | 0 = None |
| | 2 = Film reinforcement |
| Suffix - 3(x) | Third position represents "size" |
| | 0 = Small |
| | 1 = Medium |
| | 2 = Large |
| | 3 = XL |
| | 4 = XXL |
| Suffix - 4(x) | Fourth position represents "length" |
| | 0 = Standard |
| | 2 = XLong |
| | 4 = A-frame |
| Suffix - 5 | Fifth position represents "Thumb-hooks" |
| | T = with thumb-hooks |
| Suffix - 6 | Sixth position represents "packaging" |
| | S1 = Sterile |
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Image /page/6/Picture/0 description: The image contains the logo for Global Resources International, with the acronym "gri" in a stylized font. Below the logo, the text "Global Resources International" is printed in a smaller font. The image also includes the text "Table C 3- Product Catalog Number and Description".
| Catalog # | | | | | |
|--------------------|-----------------|--------------------|-----------------|---------------------------------------------------|-------------------|
| Sterile | | Non-Sterile | | | |
| Without Thumb-hook | With Thumb-hook | Without Thumb-hook | With Thumb-hook | Model Description | Size |
| i90-8200-S1 | i90-8200T-S1 | i90-8200 | i90-8200T | ComfortGuard Surgical Gown, i600, Film Reinforced | S |
| i90-8210-S1 | i90-8210T-S1 | i90-8210 | i90-8210T | ComfortGuard Surgical Gown, i600, Film Reinforced | M |
| i90-8220-S1 | i90-8220T-S1 | i90-8220 | i90-8220T | ComfortGuard Surgical Gown, i600, Film Reinforced | L |
| i90-8230-S1 | i90-8230T-S1 | i90-8230 | i90-8230T | ComfortGuard Surgical Gown, i600, Film Reinforced | XL |
| i90-8240-S1 | i90-8240T-S1 | i90-8240 | i90-8240T | ComfortGuard Surgical Gown, i600, Film Reinforced | XXL |
| i90-8222-S1 | i90-8222T-S1 | i90-8222 | i90-8222T | ComfortGuard Surgical Gown, i600, Film Reinforced | L-XLONG |
| i90-8232-S1 | i90-8232T-S1 | i90-8232 | i90-8232T | ComfortGuard Surgical Gown, i600, Film Reinforced | XL-XLONG |
| i90-8242-S1 | i90-8242T-S1 | i90-8242 | i90-8242T | ComfortGuard Surgical Gown, i600, Film Reinforced | XXL-XLONG |
| i90-8224-S1 | i90-8224T-S1 | i90-8224 | i90-8224T | ComfortGuard Surgical Gown, i600, Film Reinforced | A-frame, L-XLONG |
| i90-8234-S1 | i90-8234T-S1 | i90-8234 | i90-8234T | ComfortGuard Surgical Gown, i600, Film Reinforced | A-frame, XL-XLONG |
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Image /page/7/Picture/0 description: The image shows the logo for Global Resources International (GRI). The logo consists of the letters 'gri' in a bold, sans-serif font, with the 'i' having a curved blue accent mark above it. Below the letters, the words 'Global Resources International' are written in a smaller, sans-serif font.
#### 1.1 Summary of technological characteristics compared to the predicate
A side by side table between both proposed devices and predicate device is provided in below table.
Table C 4 Side by Side Comparison of Proposed Devices and Predicate Device
### General Information
| Element of<br>Comparison | Device Description | ComfortGuard Surgical Gown,<br>i600, Film Reinforced<br>(i90-82xx-S1) | Predicate Kimberly-Clark ULTRA<br>Film-Reinforced Surgical Gown,<br>code 954xx, 955xx<br>(K080795) | Kimberly-Clark ULTRA Surgical<br>Gown<br>code 951xx<br>(K080795) |
|-------------------------------|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | Manufacturer | GRI | Kimberly-Clark Corp. | Kimberly-Clark Corp. |
| | Product Trade<br>Name | ComfortGuard Surgical Gown,<br>i600, Film Reinforced | ULTRA Film-Reinforced Surgical<br>Gown | ULTRA Surgical Gown |
| | Classification # | Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 | Class II, 21 CFR 878.4040 |
| | Classification Name | Surgical Apparel | Surgical Apparel | Surgical Apparel |
| | Product Code | Surgical gown FYA | Surgical gown FYA | Surgical gown FYA |
| | AAMI PB 70<br>Classification | Level 4 | Level 4 | Level 3 |
| | Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| | Predicate<br>Comparison | Subject device is substantially<br>equivalent to the predicate in<br>classification and sterilization<br>method. | Predicate- This device is a level 4<br>Film-Reinforced surgical gown per<br>K080795 submission, and is used<br>as the predicate. The subject<br>device is substantially equivalent<br>to this gown for their indications<br>for use. | This Device is a Level 3 non-<br>reinforced surgical gown per<br>K080795 submission. Subject<br>device is not substantially<br>equivalent to this gown. This<br>gown is not considered as a<br>predicate. |
| Element of<br>Comparison | Device<br>Description | ComfortGuard Surgical Gown, i600,<br>Film Reinforced<br>(i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film-<br>Reinforced Surgical Gown, code<br>954xx, 955xx<br>(K080795) | Kimberly-Clark ULTRA Surgical Gown,<br>code 951xx<br>(K080795) |
| Indications for Use | Indications for Use | The ComfortGuard Surgical Gown,<br>i600, Film Reinforced is a single use<br>surgical gown intended to protect<br>surgical patients and operating room<br>personnel from the transfer of<br>microorganisms, body fluids, and<br>particulate material.<br>The ComfortGuard Surgical Gown,<br>i600, Film Reinforced has been tested<br>and is classified as Level 4 in the<br>critical zones per AAMI Standard PB70<br>Liquid barrier performance and<br>classification of protective apparel and<br>drapes intended for use in healthcare<br>facilities. | The Kimberly-Clark ULTRA Surgical<br>Gowns and ULTRA Film-Reinforced<br>Surgical Gowns are sterile, single use<br>surgical gown intended to protect<br>both the surgical patient and the<br>operating room personnel from the<br>transfer of microorganisms, body<br>fluids and particulate material.<br>The ULTRA Surgical Gowns meet Level<br>3 of the AAMI Liquid Barrier<br>classifications, and the ULTRA Film-<br>Reinforced Surgical Gowns meet Level<br>4 of the AAMI Liquid Barrier<br>classifications. | The Kimberly-Clark ULTRA Surgical<br>Gowns and ULTRA Film-Reinforced<br>Surgical Gowns are sterile, single use<br>surgical gown intended to protect<br>both the surgical patient and the<br>operating room personnel from the<br>transfer of microorganisms, body<br>fluids and particulate material.<br>The ULTRA Surgical Gowns meet Level<br>3 of the AAMI Liquid Barrier<br>classifications, and the ULTRA Film-<br>Reinforced Surgical Gowns meet Level<br>4 of the AAMI Liquid Barrier<br>classifications. |
| | Predicate<br>Comparison | Subject device is substantially<br>equivalent to the predicate in its<br>indications for use. The subject device<br>and predicate are Level 4 surgical<br>gowns. | Predicate- This device is a level 4 Film-<br>Reinforced surgical gown per K080795<br>submission, and is used as the<br>predicate. | This Device is a Level 3 non-reinforced<br>surgical gown per K080795<br>submission. Subject device is not<br>substantially equivalent to this gown.<br>This gown is not considered as a<br>predicate. |
| Element of<br>Comparison | Device Description | ComfortGuard Surgical Gown, i600,<br>Film Reinforced<br>(i90-82xx-S1) | Predicate Kimberly-Clark ULTRA<br>Film-Reinforced Surgical Gown,<br>code 954xx, 955xx<br>(K080795) | Kimberly-Clark ULTRA<br>Surgical Gown, code 951xx<br>(K080795) |
| Technological Characteristics | Device Description | The ComfortGuard Surgical Gown,<br>i600, Film Reinforced (i90-82xx-S1)<br>consists of a multi-layer in the critical<br>zones (SMS & Film Lamination),<br>single layer of SMS (polyolefin<br>nonwoven) in the non-critical zones<br>in the body and sleeve, single layer of<br>SMS (polyolefin nonwoven) in the<br>back panel with a lower basis weight<br>SMS. | Predicate Kimberly-Clark ULTRA<br>Film-Reinforced Gown is a full-<br>length, nonwoven SMS<br>polypropylene gown. The ULTRA<br>Film-Reinforced Surgical Gown is<br>film-reinforced for higher barrier<br>protection. | Kimberly-Clark ULTRA Gown<br>is a full-length, nonwoven<br>SMS polypropylene gown. |
| | | ComfortGuard Surgical Gown, i600,<br>Film Reinforced (i90-82xx-S1) is<br>provided with neck binder, hook and<br>loop tabs, belt ties, removable<br>transfer accessory, and cuffs. | Predicate Kimberly-Clark ULTRA<br>Film-Reinforced Gown is<br>constructed with raglan sleeves,<br>hook-and-loop neck closures,<br>and tie waist closures. | Kimberly-Clark ULTRA Gown<br>is constructed with raglan<br>sleeves, hook-and-loop neck<br>closures, and tie waist<br>closures. |
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#### Indications for Use
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#### Technological Characteristics
Continue on next page.
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| Technological Characteristics (cont.) | | | | |
|---------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Element of<br>Comparison | Device Description | ComfortGuard Surgical Gown, i600,<br>Film Reinforced<br>(i90-82xx-S1) | Predicate Kimberly-Clark ULTRA<br>Film-Reinforced Surgical Gown,<br>code 954xx, 955xx<br>(K080795) | Kimberly-Clark ULTRA<br>Surgical Gown, code 951xx<br>(K080795) |
| | Design Differences | The ComfortGuard Surgical Gown,<br>i600, Film Reinforced (i90-82xx-S1) is<br>constructed with or without thumb-<br>hooks in cuffs. | Predicate Kimberly-Clark ULTRA<br>Film-Reinforced Gown does not<br>have thumb-hooks in cuffs. | Kimberly-Clark ULTRA<br>Surgical Gown does not<br>have thumb-hooks in cuffs. |
| | | The ComfortGuard Surgical Gown,<br>i600, Film Reinforced (i90-82xx-S1) is<br>constructed with pleats in the back<br>panels. | Predicate Kimberly-Clark ULTRA<br>Film-Reinforced Gown is not<br>constructed with pleats in the<br>back. | Kimberly-Clark ULTRA<br>Surgical Gown is not<br>constructed with pleats in<br>the back. |
| Predicate Comparison | | The addition of thumb-hooks, back<br>pleats, and the use of a lighter basis<br>weight material in the back panels<br>does not impact the performance of<br>the gown in accordance with AAMI<br>PB70 requirement, and therefore is<br>substantially equivalent to the<br>predicate. | The predicate Kimberly-Clark<br>ULTRA Film-Reinforced Surgical<br>Gown does not include these<br>Design features | The Kimberly-Clark ULTRA<br>Surgical Gown does not<br>include these Design<br>features |
| Element of<br>Comparison | Device Description | ComfortGuard Surgical Gown,<br>i600, Film Reinforced<br>(i90-82xx-S1) | Predicate Kimberly-Clark ULTRA<br>Film-Reinforced Surgical Gown,<br>code 954xx, 955xx<br>(K080795) | Kimberly-Clark ULTRA Surgical<br>Gown, code 951xx<br>(K080795) |
| Technological Characteristics (cont.) | Material Composition | Multi-layer in the critical zones<br>(SMS & Film Lamination), single<br>layer of SMS (polyolefin<br>nonwoven) in the non-critical<br>zones in the body and sleeve,<br>single layer of SMS (polyolefin<br>nonwoven) in the back panel<br>with a lower basis weight SMS. | Multi-layer construction (SMS &<br>Film lamination) in the entire<br>front body and sleeve, single<br>layer of SMS (polyolefin<br>nonwoven) in back panels | Single Layer of SMS (polyolefin<br>nonwoven) throughout the<br>entire gown |
| | Material Additives | Alcohol-Repellency to Front Body<br>and Sleeves materials | Alcohol-Repellency throughout<br>the entire gown. | Alcohol-Repellency throughout<br>the entire gown. |
| | | Anti-Static throughout the entire<br>gown | Anti-Static throughout the entire<br>gown | Anti-Static throughout the entire<br>gown |
| | Predicate Comparison | The material compositions are<br>same as the predicate. And the<br>difference in material additives<br>does not impact the<br>performance of AAMI PB70 and<br>ISO 10993-1 requirements, and<br>therefore is substantially<br>equivalent to the predicate. | The predicate Kimberly-Clark<br>ULTRA Film-Reinforced Surgical<br>Gown meets the performance<br>requirements of AAMI PB70 and<br>ISO 10993-1 per K080795<br>submission. | The Kimberly-Clark ULTRA<br>Surgical Gown meets the<br>performance requirements of<br>AAMI PB70 and ISO 10993-1 per<br>K080795 submission. |
| Element of<br>Comparison | Device Description | ComfortGuard Surgical Gown,<br>i600, Film Reinforced<br>(i90-82xx-S1) | Predicate Kimberly-Clark ULTRA<br>Film-Reinforced Surgical Gown,<br>code 954xx, 955xx<br>(K080795) | Kimberly-Clark ULTRA Surgical<br>Gown, code 951xx<br>(K080795) |
| Safety Properties | 16 CFR Part 1610<br>(2014) Flammability | Tested and met Class 1<br>requirement | Meets Class 1 requirement per<br>K080795 submission | N/A |
| | Biocompatibility | Testing was performed<br>according to ISO 10993-5 and<br>ISO 10993-10. Under the<br>conditions of each study, the<br>device is non-cytotoxic, non-<br>sensitizing and non-irritating. | Passed ISO 10993-1 per K080795<br>submission | N/A |
| | Predicate Comparison | The ComfortGuard Surgical<br>Gown, i600, Film Reinforced<br>(i90-82xx-S1) is substantially<br>equivalent to the predicate in<br>biocompatibility performance. | Predicate Kimberly-Clark ULTRA<br>Film-Reinforced Surgical Gown<br>meets ISO 10993-1 per K080795<br>submission. | N/A |
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#### Technological Characteristics (cont.)
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## Safety Properties
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Liquid Barrier Performance Classification Properties- Critical Zones
| Element of<br>Comparison | Device Description | ComfortGuard Surgical Gown,<br>i600, Film Reinforced<br>(i90-82xx-S1) | Predicate Kimberly-Clark<br>ULTRA Film-Reinforced<br>Surgical Gown, code 954xx,<br>955xx<br>(K080795) | Kimberly-Clark ULTRA Surgical<br>Gown, code 951xx<br>(K080795) |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Liquid Barrier Performance Classification Properties -<br>Critical Zones | AAMI PB70 ASTM F1671-13<br>Viral Penetration (Pass/Fail)<br>Test Results<br>Pass/Fail<br>(Results obtained from three<br>independent Lots) | A1: Base Material: PASS<br>A2: Tie Attachment: PASS<br>B1: Lower Sleeve Seam: PASS<br>B2: Upper Sleeve Seam: PASS | Meets ASTM F1671<br>Requirements per K080795<br>submission | N/A |
| | AAMI PB70 ASTM F1671-13<br>Viral Penetration (Pass/Fail)<br>Level 4 Requirements | A1: Base Material: Pass<br>A2: Tie Attachment: Pass<br>B1: Lower Sleeve Seam: Pass<br>B2: Upper Sleeve Seam: Pass<br>AQL=4% ( $α=.05$ )<br>RQL=20% ( $β=0.10$ )<br>n=32; Acc=3; Rej=4 | Critical zone: Pass<br>Critical zone: Pass<br>Critical zone: Pass<br>Critical zone: Pass<br>N/A<br>N/A<br>N/A | N/A |
| Element of<br>Comparison | Device Description | ComfortGuard Surgical Gown,<br>i600, Film Reinforced<br>(i90-82xx-S1) | Predicate Kimberly-Clark<br>ULTRA Film-Reinforced<br>Surgical Gown, code 954xx,<br>955xx<br>(K080795) | Kimberly-Clark ULTRA<br>Surgical Gown, code<br>951xx<br>(K080795) |
| | Liquid Barrier Performance Classification Properties- Non-Critical Zone<br>(cont.) | | | |
| | AATCC 42-2013 Impact<br>Penetration<br>(grams)<br>Test Results<br>Mean (Min, Max)<br>(Results obtained from Three<br>Lots) | C1: Base Material:<br>0.03grams (0.00, 0.08)<br>C2: Sleeve Joint Sewn Seam:<br>2.26grams (0.07, 4.42)<br>C3: Sleeve Seam:<br>0.00grams (0.00, 0.05) | N/A | N/A |
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| | AAMI PB70 AATCC 42-2013<br>Impact Penetration (grams)<br>Level 1 Requirements | C1: Base Material: ≤4.5g<br>C2: Sleeve Joint Sewn Seam:<br>≤4.5g<br>C3: Sleeve Seam: ≤4.5g<br>AQL=4% (α=.05)<br>RQL=20% (β=0.10)<br>n=32; Acc=3; Rej=4 | N/A | N/A |
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| | Predicate Comparison | The ComfortGuard Surgical Gown,<br>i600, Film Reinforced (i90-82xx-S1)<br>meets PB70 level 1 requirements at<br>Non-Critical Zones. | N/A | N/A |
| Element of<br>Comparison | Device Description | ComfortGuard Surgical Gown,<br>i600, Film Reinforced<br>(i90-82xx-S1) | Predicate Kimberly-Clark<br>ULTRA Film-Reinforced<br>Surgical Gown, code 954xx,<br>955xx<br>(K080795) | Kimberly-Clark ULTRA<br>Surgical Gown, code 951xx<br>(K080795) |
| Liquid Barrier Performance Classification Properties- Non-Critical<br>Zone (cont.) | AATCC 42-2013 Impact<br>Penetration<br>(grams)<br>Test Results<br>Mean (Min, Max)<br>(Results obtained from Three<br>Lots) | D1: Back- Base Material:<br>1.00grams (0.07, 4.31)<br>D2: Back Joint Sewn Seam:<br>2.54grams (0.21, 4.48)<br>D3: Back Tie Attachment:<br>0.89grams (0.00, 4.47) | N/A | N/A |
| | AAMI PB70 AATCC 42-2013<br>Impact Penetration (grams)<br>Level 1 Requirements<br>Predicate Comparison | D1: Base Material: ≤4.5g<br>D2: Back Joint Sewn Seam: ≤4.5g<br>D3: Back Tie Attachment: ≤4.5g<br>AQL=4% (α=.05)<br>RQL=20% (β=0.10)<br>n=32; Acc=3; Rej=4<br>The ComfortGuard Surgical<br>Gown, i600, Film Reinforced<br>(i90-82xx-S1) meets PB70 level 1<br>requirements at Non-Critical<br>Zones | N/A | N/A |
| Element of<br>Comparison | Device Description | ComfortGuard Surgical Gown,<br>i600, Film Reinforced<br>(i90-82xx-S1) | Predicate Kimberly-Clark<br>ULTRA Film-Reinforced<br>Surgical Gown, code 954xx,<br>955xx<br>(K080795) | Kimberly-Clark ULTRA<br>Surgical Gown, code 951xx<br>(K080795) |
| Physical Properties | ASTM D3776 (2009) Basis<br>Weight<br>(gsm)<br>Test Results<br>Mean (Min, Max)<br>(Results obtained from Three<br>Lots) | Critical zone - Body/Sleeve<br>Material:<br>109.5gsm (103.0, 118.0)<br>Non-Critical zone- Body/Sleeve<br>Material:<br>49.3gsm (47.0, 52.0)<br>Back Material:<br>33.9gsm (32.0, 36.0) | N/A | N/A |
| | ASTM D3776 (2009) Basis<br>Weight (gsm)<br>GRI Specifications | Critical zone - Body/Sleeve<br>Material:<br>Mean =102gsm (-10, +10)<br>Non-Critical zone- Body/Sleeve<br>Material:<br>Mean =47gsm (-5, +5)<br>Back Material:<br>Mean =33gsm (-3, +3) | N/A | N/A |
| Element of<br>Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film<br>Reinforced<br>(i90-82xx-S1) | Predicate Kimberly-Clark<br>ULTRA Film-Reinforced<br>Surgical Gown, code 954xx,<br>955xx (K080795) | Kimberly-Clark ULTRA<br>Surgical Gown, code<br>951xx<br>(K080795) |
| Physical Properties (cont.) | ASTM D5034-09 (2013)<br>Grab Tensile<br>(Newton)<br>Test Result<br>Mean (Min, Max)<br>(Results obtained from<br>Three Lots) | Critical Zone Body/Sleeve Material MD:<br>170.0N (151.6, 186.7)<br>Critical Zone Body/Sleeve Material CD:<br>141.5N (115.4, 166.8)<br>Non-Critical Zone Body/Sleeve Material MD:<br>95.9N (85.2, 107.9)<br>Non-Critical Zone Body/Sleeve Material CD:<br>61.3N (53.4, 70.9)<br>Back Material MD:<br>82.6N (62.5, 101.5)<br>Back Material CD:<br>56.7N (43.1, 67.2) | N/A | N/A |
| | ASTM D5034-09 (2013)<br>Grab Tensile (Newton)<br>GRI Specifications | Critical Zone Body/Sleeve Material MD:<br>Mean MD ≥ 100N<br>Critical Zone Body/Sleeve Material CD:<br>Mean CD ≥ 70N<br>Non-Critical Zone Body/Sleeve Material MD:<br>Mean MD ≥ 40N<br>Non-Critical Zone Body/Sleeve Material CD:<br>Mean CD ≥ 20N<br>Back Material MD:<br>Mean MD ≥ 40N<br>Back Material CD:<br>Mean CD ≥ 20N | N/A | N/A |
| Element of<br>Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film<br>Reinforced<br>(i90-82xx-S1) | Predicate Kimberly-Clark<br>ULTRA Film-Reinforced<br>Surgical Gown code 954xx,<br>955xx (K080795) | Kimberly-Clark ULTRA<br>Surgical Gown, code<br>951xx<br>(K080795) |
| Physical Properties (cont.) | ASTM D5587 (2014)<br>Trapezoid Tear<br>(Newton)<br>Test Results<br>Mean (Min, Max)<br>(Results obtained from<br>Three Lots) | Critical Zone Body/Sleeve Material MD:<br>57.3N (42.8, 73.2) | N/A | N/A |
| | | Critical Zone Body/Sleeve Material CD:<br>75.0N (62.1, 88.3) | | |
| | | Non-Critical Zone Body/Sleeve Material MD:<br>16.5N (13.2, 21.4) | | |
| | | Non-Critical Zone Body/Sleeve Material CD:<br>25.4N (20.9, 34.9)…
