Who is the manufacturer of ComfortGuard Surgical Gown, i600, Film Reinforced?

Gri Medical & Electrical Technology Co., Ltd. filed the 510(k) submission for ComfortGuard Surgical Gown, i600, Film Reinforced (K163191).

What is the FDA product code for ComfortGuard Surgical Gown, i600, Film Reinforced?

FYA. It is classified under 21 CFR 878.4040 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ComfortGuard Surgical Gown, i600, Film Reinforced?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ComfortGuard Surgical Gown, i600, Film Reinforced?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ComfortGuard Surgical Gown, i600, Film Reinforced

K163191 · Gri Medical & Electrical Technology Co., Ltd. · FYA · Feb 27, 2017 · General, Plastic Surgery

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

Intended 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)

Related Devices

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K162930 — Aero Chrome* Select Breathable Performance Surgical Gowns · Halyard Health, Inc. · Apr 21, 2017
K182172 — Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) · Medline Industries, Inc. · Apr 24, 2019
K150151 — SmartGownTM surgical gown · Cardinal Health 200, Inc. · May 21, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of three curved lines that form the head, body, and tail of the figure. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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. #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Global Resources International (GRI). The logo features the letters "gri" in a bold, sans-serif font, with a curved line above the "i" that resembles a check mark. Below the letters, the words "Global Resources International" are written in a smaller, lighter font. # 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 1805 HongGao Road XiuZhou Industry Zone JiaXing, ZheJiang, China, 314031 Tel: 86-135-1135-9722 Email: mpaugh@gri-china.com | | Official Correspondent: | Harry Shaffer, President Sterilization Consulting Services LLC 10051 Oak Leaf way, Highlands Ranch, CO 80129 Tel: 303-929-3808 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 General and plastic surgery Product Code: FYA | | Predicate Device: | Kimberly-Clark ULTRA Film-Reinforced Surgical Gown(K080795) | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Global Resources International (gri). The logo features the letters 'gri' in a stylized, lowercase font, with the 'g' and 'r' connected. Above the 'i' is a blue curved line, resembling a swoosh or an arc. Below the letters is the full name of the company, 'Global Resources International', in a smaller, sans-serif font. #### 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. {5}------------------------------------------------ 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 Thumb-hooks | Model Code with 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 | {6}------------------------------------------------ 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 | {7}------------------------------------------------ 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 Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown, code 954xx, 955xx (K080795) | Kimberly-Clark ULTRA Surgical Gown code 951xx (K080795) | |-------------------------------|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General | Manufacturer | GRI | Kimberly-Clark Corp. | Kimberly-Clark Corp. | | | Product Trade Name | ComfortGuard Surgical Gown, i600, Film Reinforced | ULTRA Film-Reinforced Surgical 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 Classification | Level 4 | Level 4 | Level 3 | | | Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | | | Predicate Comparison | Subject device is substantially equivalent to the predicate in classification and sterilization method. | Predicate- This device is a level 4 Film-Reinforced surgical gown per K080795 submission, and is used as the predicate. The subject device is substantially equivalent to this gown for their indications for use. | This Device is a Level 3 non- reinforced surgical gown per K080795 submission. Subject device is not substantially equivalent to this gown. This gown is not considered as a predicate. | | Element of Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film- Reinforced Surgical Gown, code 954xx, 955xx (K080795) | Kimberly-Clark ULTRA Surgical Gown, code 951xx (K080795) | | Indications for Use | 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. | The Kimberly-Clark ULTRA Surgical Gowns and ULTRA Film-Reinforced Surgical Gowns are sterile, single use surgical gown intended to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The ULTRA Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications, and the ULTRA Film- Reinforced Surgical Gowns meet Level 4 of the AAMI Liquid Barrier classifications. | The Kimberly-Clark ULTRA Surgical Gowns and ULTRA Film-Reinforced Surgical Gowns are sterile, single use surgical gown intended to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The ULTRA Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications, and the ULTRA Film- Reinforced Surgical Gowns meet Level 4 of the AAMI Liquid Barrier classifications. | | | Predicate Comparison | Subject device is substantially equivalent to the predicate in its indications for use. The subject device and predicate are Level 4 surgical gowns. | Predicate- This device is a level 4 Film- Reinforced surgical gown per K080795 submission, and is used as the predicate. | This Device is a Level 3 non-reinforced surgical gown per K080795 submission. Subject device is not substantially equivalent to this gown. This gown is not considered as a predicate. | | Element of Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown, code 954xx, 955xx (K080795) | Kimberly-Clark ULTRA Surgical Gown, code 951xx (K080795) | | Technological Characteristics | Device Description | The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) consists of a multi-layer in the critical zones (SMS & Film Lamination), single layer of SMS (polyolefin nonwoven) in the non-critical zones in the body and sleeve, single layer of SMS (polyolefin nonwoven) in the back panel with a lower basis weight SMS. | Predicate Kimberly-Clark ULTRA Film-Reinforced Gown is a full- length, nonwoven SMS polypropylene gown. The ULTRA Film-Reinforced Surgical Gown is film-reinforced for higher barrier protection. | Kimberly-Clark ULTRA Gown is a full-length, nonwoven SMS polypropylene gown. | | | | 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. | Predicate Kimberly-Clark ULTRA Film-Reinforced Gown is constructed with raglan sleeves, hook-and-loop neck closures, and tie waist closures. | Kimberly-Clark ULTRA Gown is constructed with raglan sleeves, hook-and-loop neck closures, and tie waist closures. | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Global Resources International (GRI). The logo features the letters "gri" in a bold, sans-serif font, with the "i" having a curved extension above it. Below the letters, the words "Global Resources International" are written in a smaller, sans-serif font. #### Indications for Use {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Global Resources International (GRI). The logo features the letters 'gri' in a lowercase, sans-serif font, with a blue curved line above the 'i'. Below the letters, the words 'Global Resources International' are written in a smaller, sans-serif font. #### Technological Characteristics Continue on next page. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Global Resources International (GRI). The logo features the letters 'gri' in a stylized, italicized font, with the 'i' having a curved line above it, resembling a check mark or a swoosh. Below the letters, the words 'Global Resources International' are written in a smaller, sans-serif font. | Technological Characteristics (cont.) | | | | | |---------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Element of Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown, code 954xx, 955xx (K080795) | Kimberly-Clark ULTRA Surgical Gown, code 951xx (K080795) | | | Design Differences | The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) is constructed with or without thumb- hooks in cuffs. | Predicate Kimberly-Clark ULTRA Film-Reinforced Gown does not have thumb-hooks in cuffs. | Kimberly-Clark ULTRA Surgical Gown does not have thumb-hooks in cuffs. | | | | The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) is constructed with pleats in the back panels. | Predicate Kimberly-Clark ULTRA Film-Reinforced Gown is not constructed with pleats in the back. | Kimberly-Clark ULTRA Surgical Gown is not constructed with pleats in the back. | | Predicate Comparison | | 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, and therefore is substantially equivalent to the predicate. | The predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown does not include these Design features | The Kimberly-Clark ULTRA Surgical Gown does not include these Design features | | Element of Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown, code 954xx, 955xx (K080795) | Kimberly-Clark ULTRA Surgical Gown, code 951xx (K080795) | | Technological Characteristics (cont.) | Material Composition | Multi-layer in the critical zones (SMS & Film Lamination), single layer of SMS (polyolefin nonwoven) in the non-critical zones in the body and sleeve, single layer of SMS (polyolefin nonwoven) in the back panel with a lower basis weight SMS. | Multi-layer construction (SMS & Film lamination) in the entire front body and sleeve, single layer of SMS (polyolefin nonwoven) in back panels | Single Layer of SMS (polyolefin nonwoven) throughout the entire gown | | | Material Additives | Alcohol-Repellency to Front Body and Sleeves materials | Alcohol-Repellency throughout the entire gown. | Alcohol-Repellency throughout the entire gown. | | | | Anti-Static throughout the entire gown | Anti-Static throughout the entire gown | Anti-Static throughout the entire gown | | | Predicate Comparison | The material compositions are same as the predicate. And the difference in material additives does not impact the performance of AAMI PB70 and ISO 10993-1 requirements, and therefore is substantially equivalent to the predicate. | The predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown meets the performance requirements of AAMI PB70 and ISO 10993-1 per K080795 submission. | The Kimberly-Clark ULTRA Surgical Gown meets the performance requirements of AAMI PB70 and ISO 10993-1 per K080795 submission. | | Element of Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown, code 954xx, 955xx (K080795) | Kimberly-Clark ULTRA Surgical Gown, code 951xx (K080795) | | Safety Properties | 16 CFR Part 1610 (2014) Flammability | Tested and met Class 1 requirement | Meets Class 1 requirement per K080795 submission | N/A | | | Biocompatibility | Testing was performed according to ISO 10993-5 and ISO 10993-10. Under the conditions of each study, the device is non-cytotoxic, non- sensitizing and non-irritating. | Passed ISO 10993-1 per K080795 submission | N/A | | | Predicate Comparison | The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) is substantially equivalent to the predicate in biocompatibility performance. | Predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown meets ISO 10993-1 per K080795 submission. | N/A | Page 65 of 93 Continue on next page. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Global Resources International (GRI). The logo features the letters "gri" in a stylized 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. #### Technological Characteristics (cont.) {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for Global Resources International. The logo consists of the letters "gri" in a stylized font, with a blue arc above the "i". Below the letters, the words "Global Resources International" are written in a smaller font. The logo is simple and modern, and the use of blue suggests a connection to the environment or technology. ## Safety Properties {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for Global Resources International. The logo consists of the letters "gri" in a stylized font, with a blue arc above the "i". Below the letters, the words "Global Resources International" are written in a smaller font. Liquid Barrier Performance Classification Properties- Critical Zones | Element of Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown, code 954xx, 955xx (K080795) | Kimberly-Clark ULTRA Surgical Gown, code 951xx (K080795) | |------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | Liquid Barrier Performance Classification Properties - Critical Zones | AAMI PB70 ASTM F1671-13 Viral Penetration (Pass/Fail) Test Results Pass/Fail (Results obtained from three independent Lots) | A1: Base Material: PASS A2: Tie Attachment: PASS B1: Lower Sleeve Seam: PASS B2: Upper Sleeve Seam: PASS | Meets ASTM F1671 Requirements per K080795 submission | N/A | | | AAMI PB70 ASTM F1671-13 Viral Penetration (Pass/Fail) Level 4 Requirements | A1: Base Material: Pass A2: Tie Attachment: Pass B1: Lower Sleeve Seam: Pass B2: Upper Sleeve Seam: Pass AQL=4% ( $α=.05$ ) RQL=20% ( $β=0.10$ ) n=32; Acc=3; Rej=4 | Critical zone: Pass Critical zone: Pass Critical zone: Pass Critical zone: Pass N/A N/A N/A | N/A | | Element of Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown, code 954xx, 955xx (K080795) | Kimberly-Clark ULTRA Surgical Gown, code 951xx (K080795) | | | Liquid Barrier Performance Classification Properties- Non-Critical Zone (cont.) | | | | | | AATCC 42-2013 Impact Penetration (grams) Test Results Mean (Min, Max) (Results obtained from Three Lots) | C1: Base Material: 0.03grams (0.00, 0.08) C2: Sleeve Joint Sewn Seam: 2.26grams (0.07, 4.42) C3: Sleeve Seam: 0.00grams (0.00, 0.05) | N/A | N/A | | | | | | | | | | | | | | | | | | | | | AAMI PB70 AATCC 42-2013 Impact Penetration (grams) Level 1 Requirements | C1: Base Material: ≤4.5g C2: Sleeve Joint Sewn Seam: ≤4.5g C3: Sleeve Seam: ≤4.5g AQL=4% (α=.05) RQL=20% (β=0.10) n=32; Acc=3; Rej=4 | N/A | N/A | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Predicate Comparison | The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) meets PB70 level 1 requirements at Non-Critical Zones. | N/A | N/A | | Element of Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown, code 954xx, 955xx (K080795) | Kimberly-Clark ULTRA Surgical Gown, code 951xx (K080795) | | Liquid Barrier Performance Classification Properties- Non-Critical Zone (cont.) | AATCC 42-2013 Impact Penetration (grams) Test Results Mean (Min, Max) (Results obtained from Three Lots) | D1: Back- Base Material: 1.00grams (0.07, 4.31) D2: Back Joint Sewn Seam: 2.54grams (0.21, 4.48) D3: Back Tie Attachment: 0.89grams (0.00, 4.47) | N/A | N/A | | | AAMI PB70 AATCC 42-2013 Impact Penetration (grams) Level 1 Requirements Predicate Comparison | D1: Base Material: ≤4.5g D2: Back Joint Sewn Seam: ≤4.5g D3: Back Tie Attachment: ≤4.5g AQL=4% (α=.05) RQL=20% (β=0.10) n=32; Acc=3; Rej=4 The ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) meets PB70 level 1 requirements at Non-Critical Zones | N/A | N/A | | Element of Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown, code 954xx, 955xx (K080795) | Kimberly-Clark ULTRA Surgical Gown, code 951xx (K080795) | | Physical Properties | ASTM D3776 (2009) Basis Weight (gsm) Test Results Mean (Min, Max) (Results obtained from Three Lots) | Critical zone - Body/Sleeve Material: 109.5gsm (103.0, 118.0) Non-Critical zone- Body/Sleeve Material: 49.3gsm (47.0, 52.0) Back Material: 33.9gsm (32.0, 36.0) | N/A | N/A | | | ASTM D3776 (2009) Basis Weight (gsm) GRI Specifications | Critical zone - Body/Sleeve Material: Mean =102gsm (-10, +10) Non-Critical zone- Body/Sleeve Material: Mean =47gsm (-5, +5) Back Material: Mean =33gsm (-3, +3) | N/A | N/A | | Element of Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown, code 954xx, 955xx (K080795) | Kimberly-Clark ULTRA Surgical Gown, code 951xx (K080795) | | Physical Properties (cont.) | ASTM D5034-09 (2013) Grab Tensile (Newton) Test Result Mean (Min, Max) (Results obtained from Three Lots) | Critical Zone Body/Sleeve Material MD: 170.0N (151.6, 186.7) Critical Zone Body/Sleeve Material CD: 141.5N (115.4, 166.8) Non-Critical Zone Body/Sleeve Material MD: 95.9N (85.2, 107.9) Non-Critical Zone Body/Sleeve Material CD: 61.3N (53.4, 70.9) Back Material MD: 82.6N (62.5, 101.5) Back Material CD: 56.7N (43.1, 67.2) | N/A | N/A | | | ASTM D5034-09 (2013) Grab Tensile (Newton) GRI Specifications | Critical Zone Body/Sleeve Material MD: Mean MD ≥ 100N Critical Zone Body/Sleeve Material CD: Mean CD ≥ 70N Non-Critical Zone Body/Sleeve Material MD: Mean MD ≥ 40N Non-Critical Zone Body/Sleeve Material CD: Mean CD ≥ 20N Back Material MD: Mean MD ≥ 40N Back Material CD: Mean CD ≥ 20N | N/A | N/A | | Element of Comparison | Device Description | ComfortGuard Surgical Gown, i600, Film Reinforced (i90-82xx-S1) | Predicate Kimberly-Clark ULTRA Film-Reinforced Surgical Gown code 954xx, 955xx (K080795) | Kimberly-Clark ULTRA Surgical Gown, code 951xx (K080795) | | Physical Properties (cont.) | ASTM D5587 (2014) Trapezoid Tear (Newton) Test Results Mean (Min, Max) (Results obtained from Three Lots) | Critical Zone Body/Sleeve Material MD: 57.3N (42.8, 73.2) | N/A | N/A | | | | Critical Zone Body/Sleeve Material CD: 75.0N (62.1, 88.3) | | | | | | Non-Critical Zone Body/Sleeve Material MD: 16.5N (13.2, 21.4) | | | | | | Non-Critical Zone Body/Sleeve Material CD: 25.4N (20.9, 34.9)…