ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

• K Number: K162442
• Device Name: ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
• Manufacturer: GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD.
• Date Cleared: 2016-12-12 ( 103 days)
• Product Code: FYA
• Regulation Number: 878.4040

Intended Use

ComfortGuard Plus Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. ComfortGuard Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. ComfortGuard Surgical Gown, i500 have been tested and are classified as Level 3 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 Description

The ComfortGuard Plus Surgical Gown, i500 (i90-70xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement. The ComfortGuard Surgical Gown, i500 (i90-80xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement. Both groups of surgical gowns are provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight sizes available for each design in both sterile and non-sterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XL-XLONG, and XXL-XLONG, see Intended use/Indication for use. Both groups of surgical gowns have been tested according to AAMI PB70:2012 and met the AAMI Level 3 liquid barrier performance requirements. They are constructed with or without thumbhooks 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.

Predicate Devices

Unknown

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical surgical gown and its material properties and performance testing, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

No
The device is a surgical gown intended to protect patients and personnel from transfer of microorganisms, body fluids, and particulate material, not to treat or prevent a disease or condition.

Diagnostic

No

This device is a surgical gown, intended to provide a barrier against microorganisms and fluids. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly indicates that the device is a physical surgical gown made of polyolefin nonwoven SMS fabric, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

The provided text describes surgical gowns intended to protect patients and personnel from the transfer of microorganisms, body fluids, and particulate material. This is a description of a barrier device used in a surgical setting.

An In Vitro Diagnostic (IVD) device is defined as a medical device that is intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of donations of blood and tissue with potential recipients, or to monitor therapeutic measures.

The ComfortGuard Plus and ComfortGuard Surgical Gowns do not fit this definition. They are not used for the examination of specimens from the human body to provide diagnostic information. Their function is purely protective.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ComfortGuard Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

ComfortGuard Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

ComfortGuard Plus Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

Product codes (comma separated list FDA assigned to the subject device)

FYA

Device Description

The ComfortGuard Plus Surgical Gown, i500 (i90-70xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.

The ComfortGuard Surgical Gown, i500 (i90-80xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.

Both groups of surgical gowns are provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight sizes available for each design in both sterile and non-sterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XL-XLONG, and XXL-XLONG, see Intended use/Indication for use.

Both groups of surgical gowns have been tested according to AAMI PB70:2012 and met the AAMI Level 3 liquid barrier performance requirements. They are constructed with or without thumbhooks 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Operating room personnel / healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Biocompatibility Studies: 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.

Liquid Barrier Performance Classification Properties – Critical Zones:
Tested according to AATCC 127-2014 Hydrostatic Pressure (mmH2O) and AATCC 42-2013 Impact Penetration (grams).
ComfortGuard Plus Surgical Gown, i500:

• A1: Base Material: 657mmH2O (548, 796); 0.04g (0.01, 0.06)
• A2: Tie Attachment: 668mmH2O (572, 756); 0.02g (0.00, 0.10)
• B1: Sleeve Seam: 760mmH2O (635, 864); 0.04g (0.02, 0.09)
• All met AAMI PB70 AATCC 127-2014 requirements (≥500mmH2O) and AAMI PB70 AATCC 42-2013 requirements (≤1.0g).
• AQL=4% (α=.05), RQL=20% (β=0.10), n=32; Acc=3; Rej=4.

ComfortGuard Surgical Gown, i500:

• A1: Base Material: 749mmH2O (625, 825); 0.07g (0.03, 0.16)
• A2: Tie Attachment: 637mmH2O (560, 706); 0.01g (0.00, 0.07)
• B1: Sleeve Seam: 689mmH2O (576, 805); 0.06g (0.03, 0.09)
• All met AAMI PB70 AATCC 127-2014 requirements (≥500mmH2O) and AAMI PB70 AATCC 42-2013 requirements (≤1.0g).
• AQL=4% (α=.05), RQL=20% (β=0.10), n=32; Acc=3; Rej=4.

Liquid Barrier Performance Classification Properties – Non-Critical Zone (AATCC 42-2013 Impact Penetration (grams)):
ComfortGuard Plus Surgical Gown, i500:

• C1: Base Material: 0.02g (0.00, 0.11)
• C2: Sleeve Joint Sewn Seam: 0.25g (0.00,1.71)
• C3: Sleeve Seam: 0.06g (0.00, 0.48)
• D1: Back- Base Material: 0.17g (0.04, 0.33)
• D2: Back Joint Sewn Seam: 1.56g (0.03, 4.03)
• D3: Back Tie Attachment: 0.86g (0.04, 3.99)
• All met AAMI PB70 AATCC 42-2013 requirements (≤4.5g).
• AQL=4% (α=.05), RQL=20% (β=0.10), n=32; Acc=3; Rej=4.

ComfortGuard Surgical Gown, i500:

• C1: Base Material: 0.03g (0.00, 0.08)
• C2: Sleeve Joint Sewn Seam: 0.29g (0.00, 2.68)
• C3: Sleeve Seam: 0.03g (0.00, 0.09)
• D1: Back- Base Material: 0.27g (0.07, 0.72)
• D2: Back Joint Sewn Seam: 1.93g (0.30, 4.16)
• D3: Back Tie Attachment: 0.65g (0.06, 3.84)
• All met AAMI PB70 AATCC 42-2013 requirements (≤4.5g).
• AQL=4% (α=.05), RQL=20% (β=0.10), n=32; Acc=3; Rej=4.

Physical Properties (ASTM D3776 (2009) Basis Weight (gsm) Test Results):
ComfortGuard Plus Surgical Gown, i500:

• Body/Sleeve Material: 46gsm (44, 47)
• Back Material: 34gsm (31, 35)
• Met GRI Specifications: Mean MD ≥50N, Mean CD ≥30N, Mean MD ≥40N, Mean CD ≥20N.

ComfortGuard Surgical Gown, i500:

• Body/Sleeve Material: 50gsm (47, 52)
• Back Material: 33gsm (32, 35)
• Met GRI Specifications: Mean MD ≥50N, Mean CD ≥30N, Mean MD ≥40N, Mean CD ≥20N.

Physical Properties (ASTM D5034-09 (2013) Grab Tensile (Newton) Test Result):
ComfortGuard Plus Surgical Gown, i500:

• Body/Sleeve Material MD: 82.84N (70.28, 92.31)
• Body/Sleeve Material CD: 58.54N (49.24, 64.48)
• Back Material MD: 89.52N (75.43, 103.93)
• Back Material CD: 56.32N (47.31, 65.63)
• Met GRI Specifications: Body/Sleeve Material: Mean MD ≥50N, Mean CD ≥30N; Back Material: Mean MD ≥40N, Mean CD ≥20N.

ComfortGuard Surgical Gown, i500:

• Body/Sleeve Material MD: 98.93N (88.17, 108.44)
• Body/Sleeve Material CD: 61.34N (54.26, 69.80)
• Back Material MD: 83.87N (68.05, 96.05)
• Back Material CD: 56.16N (45.65, 66.43)
• Met GRI Specifications: Body/Sleeve Material: Mean MD ≥50N, Mean CD ≥30N; Back Material: Mean MD ≥40N, Mean CD ≥20N.

Physical Properties (ASTM D5587 (2014) Trapezoid Tear (Newton) Test Results):
ComfortGuard Plus Surgical Gown, i500:

• Body/Sleeve Material: 19.01N (15.46,22.85)
• Body/Sleeve Material CD: 28.14N (24.33, 32.39)
• Back Material MD: 21.19N (16.94, 28.26)
• Back Material CD: 37.00N (30.30, 47.08)
• Met GRI Specifications: Body/Sleeve Material: Mean MD ≥10N, Mean CD ≥20N; Back Material: Mean MD ≥10N, Mean CD ≥20N.

ComfortGuard Surgical Gown, i500:

• Body/Sleeve Material MD: 15.69N (13.24, 19.04)
• Body/Sleeve Material CD: 25.40N (21.47, 30.65)
• Back Material MD: 20.74N (15.34, 28.05)
• Back Material CD: 35.49N (29.12, 46.19)
• Met GRI Specifications: Body/Sleeve Material: Mean MD ≥10N, Mean CD ≥20N; Back Material: Mean MD ≥10N, Mean CD ≥20N.

Physical Properties (ASTM D1683 (2007) Seam Strength (Newton) Test Results):
ComfortGuard Plus Surgical Gown, i500:

• Sleeve Seam: 38.80N (27.88, 48.77)
• Met GRI Specifications: Sleeve seam: Mean ≥15N.

ComfortGuard Surgical Gown, i500:

• Sleeve Seam: 49.01N (28.10, 63.29)
• Met GRI Specifications: Sleeve seam: Mean ≥15N.

Key Results: Based on the results of the biocompatibility and physical performance testing, the GRI Surgical Gowns are as safe and as performs as well as the predicate device for their intended use. The GRI Surgical Gowns are substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K080795

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
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.(b)
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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

December 12, 2016

GRI Medical & Electrical Technology Co., Ltd. % Harry Shaffer President Sterilization Consulting Services, LLC 10051 Oak Leaf Way Highlands Ranch, Colorado 80129

Re: K162442

Trade/Device Name: ComfortGuard Plus Surgical Gown, i500 ComfortGuard Surgical Gown, i500 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: November 4, 2016 Received: November 7, 2016

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 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

1

the quality systems (OS) 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Ryan -S

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

Image /page/2/Picture/0 description: The image shows the logo for GRI, which appears to stand for Global Reporting Initiative. The logo is in black and features the letters 'gri' in a stylized, lowercase font. Above the 'i' is a curved blue line, resembling a check mark or a swoosh. The overall design is simple and modern.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162442

Device Name

ComfortGuard Surgical Gown, i500

Indications for Use (Describe)

ComfortGuard Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

ComfortGuard Surgical Gown, i500 have been tested and are classified as Level 3 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."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services [phone] EF

Confidential

3

Image /page/3/Picture/0 description: The image shows the logo for GRI, which is a company that provides sustainability reporting standards. The logo is black and white, with the letters "gri" in a stylized font. There is a blue curved line above the letters. The logo is simple and modern.

Global Resources International

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration

Indications for Use

510(k) Number (if known) K162442

Device Name

ComfortGuard Plus Surgical Gown, i500

Indications for Use (Describe)

ComfortGuard Plus Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 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."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services [phone] EF

4

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:	December 7th, 2016
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: [phone]
Email: [e-mail]
Official Correspondent:	Harry Shaffer, President
Sterilization Consulting Services LLC
10051 Oak Leaf way, Highlands Ranch, CO 80129
Tel: [phone]
Email: [e-mail]
Device Trade Name:	ComfortGuard Plus Surgical Gown, i500
ComfortGuard Surgical Gown, i500
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 Surgical Gown (K080795)

5

Description of the Device 1.1

The ComfortGuard Plus Surgical Gown, i500 (i90-70xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.

The ComfortGuard Surgical Gown, i500 (i90-80xx-S1) is comprised of a single layer of polyolefin nonwoven SMS fabric throughout the entire gown, with no additional reinforcement.

Both groups of surgical gowns are provided with neck binder, hook and loop tabs, belt ties, removable transfer accessory, and cuffs. There are eight sizes available for each design in both sterile and non-sterile packaging configurations, including: S, M, L, XL, XXL, L-XLONG, XL-XLONG, and XXL-XLONG, see Intended use/Indication for use.

Both groups of surgical gowns have been tested according to AAMI PB70:2012 and met the AAMI Level 3 liquid barrier performance requirements. They are constructed with or without thumbhooks 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

ComfortGuard Plus Surgical Gown, i500

ComfortGuard Plus Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

ComfortGuard Plus Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

ComfortGuard Surgical Gown, i500

ComfortGuard Surgical Gown, i500 are single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

ComfortGuard Surgical Gown, i500 have been tested and are classified as Level 3 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

6

Table C-1 Product List

Product List
Product Name	Model Code without
Thumb-hooks	Model Code with
Thumb-hooks
ComfortGuard Plus Surgical Gown, i500	i90-70xx-S1	i90-70xxT-S1
	i90-70xx	i90-70xxT
ComfortGuard Surgical Gown, i500	i90-80xx-S1	i90-80xxT-S1
	i90-80xx	i90-80xxT

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 front "fabric"
7 = Soft SMS
8 = 47gsm SMS
Suffix - 2	Second position represents "reinforcement"
0 = None
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
Suffix - 5	Fifth position represents "Thumb-hooks"
T = with thumb-hooks
Suffix - 6	Sixth position represents "packaging"
S1 = Sterile

7

1.3 Product Codes covered in this submission

Table C-3- Product Catalog Number and Description

Catalog #				Model Description	Size
Sterile	Non-Sterile
Without Thumb-hook	With Thumb-hook	Without Thumb-hook	With Thumb-hook
i90-7000-
S1	i90-7000T-
S1	i90-7000	i90-7000T	ComfortGuard Plus Surgical Gown, i500	S
i90-7010-
S1	i90-7010T-
S1	i90-7010	i90-7010T	ComfortGuard Plus Surgical Gown, i500	M
i90-7020-
S1	i90-7020T-
S1	i90-7020	i90-7020T	ComfortGuard Plus Surgical Gown, i500	L
i90-7030-
S1	i90-7030T-
S1	i90-7030	i90-7030T	ComfortGuard Plus Surgical Gown, i500	XL
i90-7040-
S1	i90-7040T-
S1	i90-7040	i90-7040T	ComfortGuard Plus Surgical Gown, i500	XXL
i90-7022-
S1	i90-7022T-
S1	i90-7022	i90-7022T	ComfortGuard Plus Surgical Gown, i500	L-XLONG
i90-7032-
S1	i90-7032T-
S1	i90-7032	i90-7032T	ComfortGuard Plus Surgical Gown, i500	XL-XLONG
i90-7042-
S1	i90-7042T-
S1	i90-7042	i90-7042T	ComfortGuard Plus Surgical Gown, i500	XXL-XLONG
i90-8000-
S1	i90-8000T-
S1	i90-8000	i90-8000T	ComfortGuard Surgical Gown, i500	S
i90-8010-
S1	i90-8010T-
S1	i90-8010	i90-8010T	ComfortGuard Surgical Gown, i500	M
i90-8020-
S1	i90-8020T-
S1	i90-8020	i90-8020T	ComfortGuard Surgical Gown, i500	L
i90-8030-
S1	i90-8030T-
S1	i90-8030	i90-8030T	ComfortGuard Surgical Gown, i500	XL
i90-8040-
S1	i90-8040T-
S1	i90-8040	i90-8040T	ComfortGuard Surgical Gown, i500	XXL
i90-8022-
S1	i90-8022T-
S1	i90-8022	i90-8022T	ComfortGuard Surgical Gown, i500	L-XLONG
i90-8032-
S1	i90-8032T-
S1	i90-8032	i90-8032T	ComfortGuard Surgical Gown, i500	XL-XLONG
i90-8042-
S1	i90-8042T-
S1	i90-8042	i90-8042T	ComfortGuard Surgical Gown, i500	XXL-XLONG

8

1.4 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 Plus
Surgical Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-Clark
ULTRA Surgical Gown ,
code 951xx
(K080795) | Kimberly-Clark ULTRA
Film-Reinforced Surgical
Gown, code 954xx, 955xx
(K080795) |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | Manufacturer | GRI | GRI | Kimberly-Clark Corp. | Kimberly-Clark Corp. |
| | Product Trade
Name | ComfortGuard Plus
Surgical Gown, i500 | ComfortGuard Surgical
Gown, i500 | ULTRA Surgical Gown | ULTRA Film-Reinforced
Surgical Gown |
| | Classification # | Class II, 21 CFR 878.4040 | 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 | Surgical Apparel |
| | Product Code | Surgical gown FYA | Surgical gown FYA | Surgical gown FYA | Surgical gown FYA |
| | AAMI PB 70
Classification | Level 3 | Level 3 | Level 3 | Level 4 |
| | Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| | Predicate
Comparison | Subject device is
substantially equivalent to
the predicate in
classification and
sterilization method. | Subject device is
substantially equivalent to
the predicate in
classification and
sterilization method. | Predicate- This Device is a
Level 3 non-reinforced
surgical gown per K080795
submission, and is used as
the predicate. The subject
devices are substantially
equivalent to this gown for
their intended use. | This device is a level 4
Film-Reinforced surgical
gown per K080795
submission. Subject
devices are not
substantially equivalent to
this gown. This gown is not
considered as a predicate. |
| Element of
Comparison | Device
Description | ComfortGuard Plus Surgical
Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-Clark
ULTRA Surgical Gown, code
951xx
(K080795) | Kimberly-Clark ULTRA Film-
Reinforced Surgical Gown,
code 954xx, 955xx
(K080795) |
| Indications for Use | Indications for Use | ComfortGuard Plus Surgical
Gown, i500 are single use
surgical gowns intended to
protect surgical patients
and operating room
personnel from the transfer
of microorganisms, body
fluids, and particulate
material.
ComfortGuard Plus Surgical
Gown, i500 have been tested
and are classified as Level 3
in the critical zones per AAMI
Standard PB70 Liquid barrier
performance and
classification of protective
apparel and drapes intended
for use in healthcare
facilities. | ComfortGuard Surgical
Gown, i500 are single use
surgical gowns intended to
protect surgical patients
and operating room
personnel from the transfer
of microorganisms, body
fluids, and particulate
material.
ComfortGuard Surgical
Gown, i500 have been tested
and are classified as Level 3
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 3 surgical gowns. | Subject device is substantially
equivalent to the predicate in
its indications for use. The
subject device and predicate
are Level 3 surgical gowns. | Predicate- This Device is a
Level 3 non-reinforced
surgical gown per K080795
submission, and is used as
the predicate. | This device is a level 4 Film-
Reinforced surgical gown per
K080795 submission. Subject
devices are not substantially
equivalent to this gown. This
gown is not considered as a
predicate | |
| Element of
Comparison | Device
Description | ComfortGuard Plus
Surgical Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-Clark
ULTRA Surgical Gown ,
code 951xx
(K080795) | Kimberly-Clark ULTRA
Film-Reinforced Surgical
Gown, code 954xx, 955xx
(K080795) |
| Technological Characteristics | Device
Description | The ComfortGuard Plus
Surgical Gown, i500 (i90-
70xx-S1) is comprised of a
single layer of polyolefin
nonwoven SMS fabric
throughout the entire
gown, with no additional
reinforcement. | The ComfortGuard
Surgical Gown, i500 (i90-
80xx-S1) is comprised of a
single layer of polyolefin
nonwoven SMS fabric
throughout the entire
gown, with no additional
reinforcement. | Predicate Kimberly-Clark
ULTRA Gown is a full-
length, nonwoven SMS
polypropylene gown. | 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. |
| | | The ComfortGuard Plus
Surgical Gown, i500 (i90-
70xx-S1) is provided with
neck binder, hook and
loop tabs, belt ties,
removable transfer
accessory, and cuffs. | The ComfortGuard
Surgical Gown, i500 (i90-
80xx-S1) is provided with
neck binder with hook
and loop tabs, belt ties,
removable transfer
accessory, and cuffs. | Predicate Kimberly-Clark
ULTRA Gown is
constructed with raglan
sleeves, hook-and-loop
neck closures, and tie
waist closures. | Kimberly-Clark ULTRA
Film-Reinforced Gown is
constructed with raglan
sleeves, hook-and-loop
neck closures, and tie
waist closures. |
| Element
of | Device
Description | ComfortGuard Plus Surgical
Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-Clark
ULTRA Surgical Gown,
code 951xx
(K080795) | Kimberly-Clark ULTRA
Film-Reinforced Surgical
Gown, code 954xx, 955xx
(K080795) |
| Technological Characteristics (cont.) | | The ComfortGuard Plus
Surgical Gown, i500 (i90-
70xx-S1) is constructed with
or without thumb-hooks in
cuffs. | The ComfortGuard Surgical
Gown, i500 (i90-80xx-S1)
constructed with or without
thumb-hooks in cuffs. | The predicate does not
have thumb-hooks in
cuffs. | Kimberly-Clark ULTRA
Film-Reinforced Gown
does not have thumb-
hooks in cuffs. |
| | Design
Differences | The ComfortGuard Plus
Surgical Gown, i500 (i90-
70xx-S1) is constructed with
pleats in the back panels. | The ComfortGuard Surgical
Gown, i500 (i90-80xx-S1)
constructed with pleats in
the back panels. | The predicate is not
constructed with pleats in
the back. | Kimberly-Clark ULTRA
Film-Reinforced Gown is
not constructed with
pleats in the back. |
| | | The ComfortGuard Plus
Surgical Gown, i500 (i90-
70xx-S1) is constructed with
a lower basis weight SMS in
the back panels. | The ComfortGuard Surgical
Gown, i500 (i90-80xx-S1) is
constructed with a lower
basis weight SMS in the back
panels. | The predicate utilizes the
same basis weight SMS
throughout the entire
gown. | Kimberly-Clark ULTRA
Film-Reinforced Gown is
comprised of multiple
materials and is not
considered as a predicate. |
| | 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 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 Surgical Gown
does not include these
Design features | The predicate Kimberly-
Clark Ultra Film-
Reinforced Surgical Gown
does not include these
Design features |
| Element of
Comparison | Device
Description | ComfortGuard Plus
Surgical Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-Clark
ULTRA Surgical Gown ,
code 951xx
(K080795) | Kimberly-Clark ULTRA
Film-Reinforced Surgical
Gown, code 954xx, 955xx
(K080795) |
| Technological Characteristics (cont.) | Material
Composition | Single layer of Soft SMS
(polyolefin nonwoven) in
the front and sleeve,
single layer of SMS
(Polyolefin nonwoven) in
the back panels with a
lower basis weight SMS | Single layer of SMS
(polyolefin nonwoven) in
the front and sleeve,
single layer of SMS
(Polyolefin nonwoven) in
the back panels with a
lower basis weight SMS | Single Layer of SMS
(polyolefin nonwoven)
throughout the entire
gown | Multi-layer construction
(SMS & Film lamination)
in the entire front body
and sleeve, single layer of
SMS (polyolefin
nonwoven) in back panels |
| | Material
Additives | Alcohol-Repellency to
Front Body and Sleeves
material
Anti-Static throughout | Alcohol-Repellency to
Front Body and Sleeves
material
Anti-Static throughout | Alcohol-Repellency
throughout the entire
gown.
Anti-Static throughout | Alcohol-Repellency
throughout the entire
gown.
Anti-Static throughout |
| | | the entire gown
Softness treatment to
Body and Sleeves
material | the entire gown
No softness treatment | the entire gown
N/A | the entire gown
N/A |
| | Predicate
Comparison | The material additives do
not impact the
performance of the gown
in accordance with AAMI
PB70 and ISO 10993-1
requirements, and
therefore is substantially
equivalent to the
predicate. | The material additives do
not impact the
performance of the gown
in accordance with AAMI
PB70 and ISO 10993-1
requirements, and
therefore is substantially
equivalent to the
predicate. | The predicate Kimberly-
Clark Ultra Surgical Gown
meets the performance
requirements of AAMI
PB70 and ISO 10993-1 per
K080795 submission. | The Kimberly-Clark Ultra
Film-Reinforced Surgical
Gown meets the
performance
requirements of AAMI
PB70 and ISO 10993-1 per
K080795 submission. |
| Element of
Comparison | Device
Description | ComfortGuard Plus
Surgical Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-Clark
ULTRA Surgical Gown ,
code 951xx
(K080795) | Kimberly-Clark ULTRA
Film-Reinforced Surgical
Gown, code 954xx, 955xx
(K080795) |
| Safety Properties | 16 CFR Part 1610
(2014)
Flammability | Tested and met Class 1
requirement | 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. | 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 | ComfortGuard Plus
Surgical Gown, i500
(i90-70xx-S1) is
substantially equivalent
to the predicate in
biocompatibility
performance. | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) is
substantially equivalent
to the predicate in
biocompatibility
performance. | Kimberly-Clark ULTRA
Surgical Gown meets ISO
10993-1 per K080795
submission. | N/A |
| Element of
Comparison | Device Description | ComfortGuard Plus
Surgical Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-Clark
ULTRA Surgical Gown ,
code 951xx
(K080795) | Kimberly-Clark ULTRA
Film-Reinforced Surgical
Gown, code 954xx, 955xx
(K080795) |
| Liquid Barrier Performance Classification Properties – Critical
Zones | AATCC 127-2014
Hydrostatic Pressure
(mmH2O)
Test Results
Mean (Min, Max)
(Results obtained
from Three Lots) | A1: Base Material:
657mmH2O (548, 796)
A2: Tie Attachment:
668mmH2O (572, 756)
B1: Sleeve Seam:
760mmH2O (635, 864) | A1: Base Material:
749mmH2O (625, 825)
A2: Tie Attachment:
637mmH2O (560, 706)
B1: Sleeve Seam:
689mmH2O (576, 805) | Meets AATCC 127
Requirements per
K080795 submission | N/A |
| | AAMI PB70 AATCC
127-2014 Hydrostatic
Pressure (mmH2O)
Requirements | A1: Base Material:
≥500mmH2O
A2: Tie Attachment:
≥500mmH2O
B1: Sleeve Seam:
≥500mmH2O | A1: Base Material:
≥500mmH2O
A2: Tie Attachment:
≥500mmH2O
B1: Sleeve Seam:
≥500mmH2O | | Front Body: ≥500mmH2O
Front Body: ≥500mmH2O
Sleeve Seam:
≥500mmH2O |
| | | AQL=4% (α=.05)
RQL=20% (β=0.10)
n=32; Acc=3; Rej=4 | AQL=4% (α=.05)
RQL=20% (β=0.10)
n=32; Acc=3; Rej=4 | | N/A
N/A
N/A |
| Element of Comparison | Device Description | ComfortGuard Plus
Surgical Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-
Clark ULTRA Surgical
Gown , code 951xx
(K080795) | Kimberly-Clark ULTRA
Film-Reinforced
Surgical Gown, code
954xx, 955xx
(K080795) |
| Liquid Barrier Performance Classification Properties – Critical Zones (cont.) | AATCC 42-2013
Impact Penetration
(grams)
Test Results
Mean (Min, Max)
(Results obtained
from Three Lots) | A1: Base Material:
0.04g (0.01, 0.06)

A2: Tie Attachment:
0.02g (0.00, 0.10)

B1: Sleeve Seam:
0.04g (0.02, 0.09) | A1: Base Material:
0.07g (0.03, 0.16)

A2: Tie Attachment:
0.01g (0.00, 0.07)

B1: Sleeve Seam:
0.06g (0.03, 0.09) | Meets AATCC 42
Requirements per
K080795 submission | N/A |
| | AAMI PB70 AATCC
42-2013 Impact
Penetration (grams)
Requirements | A1: Base Material: ≤1.0g

A2: Tie Attachment: ≤1.0g

B1: Sleeve Seam: ≤1.0g | A1: Base Material: ≤1.0g

A2: Tie Attachment ≤1.0g

B1: Sleeve Seam: ≤1.0g | Front Body: ≤1.0g

Front Body: ≤1.0g

Sleeve Seam: ≤1.0g | |
| | | AQL=4% (α=.05) | AQL=4% (α=.05) | N/A | |
| | | RQL=20% (β=0.10) | RQL=20% (β=0.10) | N/A | |
| | | n=32; Acc=3; Rej=4 | n=32; Acc=3; Rej=4 | N/A | |
| | Predicate
Comparison | The GRI ComfortGuard Plus
Surgical Gown, i500 (i90-
70xx-S1) meets PB70 level
3 requirements at Critical
Zones and therefore is
substantially equivalent to
the predicate. | The GRI ComfortGuard
Surgical Gown, i500 (i90-
80xx-S1) meets PB70 level
3 requirements at Critical
Zones and therefore is
substantially equivalent to
the predicate. | The Predicate Device
Kimberly-Clark Ultra
Surgical Gown meets
PB70 level 3
requirements per
K080795 submission. | |
| Element of
Comparison | Device Description | ComfortGuard Plus
Surgical Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-
Clark ULTRA Surgical
Gown, code 951xx
(K080795) | Kimberly-Clark ULTRA
Film-Reinforced
Surgical Gown, code
954xx, 955xx
(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:
0.02g (0.00, 0.11)
C2: Sleeve Joint Sewn
Seam:
0.25g (0.00,1.71)
C3: Sleeve Seam:
0.06g (0.00, 0.48) | C1: Base Material:
0.03g (0.00, 0.08)
C2: Sleeve Joint Sewn
Seam:
0.29g (0.00, 2.68)
C3: Sleeve Seam:
0.03g (0.00, 0.09) | N/A |
| AAMI PB70 AATCC 42-
2013 Impact
Penetration (grams)
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 | 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 GRI ComfortGuard
Plus Surgical Gown,
i500 (i90-70xx-S1)
meets PB70 level 1
requirements at Non-
Critical Zones. | The GRI ComfortGuard
Surgical Gown, i500
(i90-80xx-S1) meets
PB70 level 1
requirements at Non-
Critical Zones. | N/A | N/A |
| Element of
Comparison | Device Description | ComfortGuard Plus
Surgical Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-
Clark ULTRA Surgical
Gown, code 951xx
(K080795) | Kimberly-Clark ULTRA
Film-Reinforced
Surgical Gown, code
954xx, 955xx
(K080795) |
| Liquid Barrier Performance Classification Properties- Non-Critical Zone
(cont.) | AATCC 42-2013
Impact Penetration
(grams) | D1: Back- Base Material:
0.17g (0.04, 0.33) | D1: Back- Base Material:
0.27g (0.07, 0.72) | N/A | N/A |
| | Test Results
Mean (Min, Max) | D2: Back Joint Sewn Seam:
1.56g (0.03, 4.03) | D2: Back Joint Sewn Seam:
1.93g (0.30, 4.16) | | |
| | (Results obtained
from Three Lots) | D3: Back Tie Attachment:
0.86g (0.04, 3.99) | D3: Back Tie Attachment:
0.65g (0.06, 3.84) | | |
| AAMI PB70 AATCC
42-2013 Impact
Penetration (grams)
Requirements | D1: Base Material: ≤4.5g | D1: Base Material: ≤4.5g | | | |
| | D2: Back Joint Sewn Seam: ≤4.5g | D2: Back Joint Sewn Seam: ≤4.5g | | | |
| | D3: Back Tie Attachment: ≤4.5g | D3: Back Tie Attachment: ≤4.5g | | | |
| | AQL=4% (α=.05)
RQL=20% (β=0.10)
n=32; Acc=3; Rej=4 | AQL=4% (α=.05)
RQL=20% (β=0.10)
n=32; Acc=3; Rej=4 | | | |
| Predicate
Comparison | The GRI ComfortGuard
Plus Surgical Gown, i500
(i90-70xx-S1) meets PB70
level 1 requirements at
Non-Critical Zones | The GRI ComfortGuard
Surgical Gown, i500 (i90-
80xx-S1) meets PB70 level
1 requirements at Non-
Critical Zones | | | |
| Element of
Comparison | Device Description | ComfortGuard Plus
Surgical Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-
Clark ULTRA Surgical
Gown, code 951xx
(K080795) | Kimberly-Clark ULTRA
Film-Reinforced
Surgical Gown, code
954xx, 955xx
(K080795) |
| Physical Properties | ASTM D3776 (2009)
Basis Weight
(gsm)
Test Results
Mean (Min, Max)
(Results obtained from
Three Lots) | Body/Sleeve Material:
46gsm (44, 47) | Body/Sleeve Material:
50gsm (47, 52) | N/A | N/A |
| | | Back Material:
34gsm (31, 35) | Back Material:
33gsm (32, 35) | | |
| | | | | | |
| | ASTM D3776 (2009)
Basis Weight (gsm)
GRI Specifications | Body/Sleeve Material:
Mean=43gsm (-2, +6) | Body/Sleeve Material:
Mean=47gsm (-2, +6) | N/A | N/A |
| | | Back Material:
Mean=33gsm (-2, +6) | Back Material:
Mean=33gsm (-2, +6) | | |

9

Indications for Use

10

Technological Characteristics

11

Technological Characteristics (cont.)

12

Technological Characteristics (cont.)

13

Safety Properties

14

Liquid Barrier Performance Classification Properties- Critical Zones

15

Liquid Barrier Performance Classification Properties- Critical Zones (cont.)

16

Liquid Barrier Performance Classification Properties- Non-Critical Zone Front and Sleeve (cont.)

17

Liquid Barrier Performance Classification Properties- Non-Critical Zone Back (cont.)

18

Physical Properties

19

Physical Properties (cont.)

| Element of
Comparison | Device Description | ComfortGuard Plus
Surgical Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-
Clark ULTRA Surgical
Gown , code 951xx
(K080795) | Kimberly-Clark ULTRA
Film-Reinforced
Surgical Gown, code
954xx, 955xx
(K080795) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Physical Properties (cont.) | ASTM D5034-09 (2013)
Grab Tensile
(Newton)
Test Result
Mean (Min, Max)
(Results obtained from
Three Lots) | Body/Sleeve Material
MD:
82.84N (70.28, 92.31)
Body/Sleeve Material
CD:
58.54N (49.24, 64.48)
Back Material MD:
89.52N (75.43, 103.93)
Back Material CD:
56.32N (47.31, 65.63) | Body/Sleeve Material
MD:
98.93N (88.17, 108.44)
Body/Sleeve Material
CD:
61.34N (54.26, 69.80)
Back Material MD:
83.87N (68.05, 96.05)
Back Material CD:
56.16N (45.65, 66.43) | N/A | N/A |
| | ASTM D5034-09 (2013)
Grab Tensile (Newton)
GRI Specifications | Body/Sleeve Material:
Mean MD ≥50N
Body/Sleeve Material:
Mean CD ≥30N
Back Material:
Mean MD ≥40N
Back Material:
Mean CD ≥20N
PASS/FAIL | Body/Sleeve Material:
Mean MD ≥50N
Body/Sleeve Material:
Mean CD ≥30N
Back Material:
Mean MD ≥40N
Back Material:
Mean CD ≥20N
PASS/FAIL | N/A | N/A |

20

Physical Properties (cont.)

| Element of
Comparison | Device
Description | ComfortGuard Plus
Surgical Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-Clark
ULTRA Surgical Gown ,
code 951xx
(K080795) | Kimberly-Clark ULTRA
Film-Reinforced Surgical
Gown, code 954xx, 955xx
(K080795) |
|-----------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Physical Properties (cont.) | ASTM D5587
(2014) Trapezoid
Tear | Body/Sleeve Material:
19.01N (15.46,22.85) | Body/Sleeve Material
MD:
15.69N (13.24, 19.04) | | |
| | (Newton)
Test Results | Body/Sleeve Material CD:
28.14N (24.33, 32.39) | Body/Sleeve Material CD:
25.40N (21.47, 30.65) | N/A | N/A |
| | Mean (Min, Max)
(Results obtained
from Three Lots) | Back Material MD:
21.19N (16.94, 28.26) | Back Material MD:
20.74N (15.34, 28.05) | | |
| | | Back Material CD:
37.00N (30.30, 47.08) | Back Material CD:
35.49N (29.12, 46.19) | | |
| | ASTM D5587
(2014) Trapezoid
Tear (Newton)
GRI Specifications | Body/Sleeve Material:
Mean MD ≥10N | Body/Sleeve Material:
Mean MD ≥10N | N/A | N/A |
| | | Body/Sleeve Material:
Mean CD ≥20N | Body/Sleeve Material:
Mean CD ≥20N | | |
| | | Back Material:
Mean MD ≥10N | Back Material:
Mean MD ≥10N | | |
| | | Back Material:
Mean CD ≥20N | Back Material:
Mean CD ≥20N | N/A | N/A |
| | | | PASS/FAIL | PASS/FAIL | N/A |

21

Physical Properties (cont.)

| Element of
Comparison | Device Description | ComfortGuard Plus
Surgical Gown, i500
(i90-70xx-S1) | ComfortGuard Surgical
Gown, i500
(i90-80xx-S1) | Predicate Kimberly-Clark
ULTRA Surgical Gown ,
code 951xx
(K080795) | Kimberly-Clark ULTRA
Film-Reinforced Surgical
Gown, code 954xx, 955xx
(K080795) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Physical Properties (cont.) | ASTM D1683 (2007)
Seam Strength
(Newton)
Test Results
Mean (Min, Max)
(Results obtained
from Three Lots) | Sleeve Seam:
38.80N (27.88, 48.77) | Sleeve Seam:
49.01N (28.10, 63.29) | N/A | N/A |
| | ASTM D1683 (2007)
Seam Strength
(Newton)
GRI Specifications | Sleeve seam: Mean
≥15N
PASS/FAIL | Sleeve seam: Mean ≥15N
PASS/FAIL | N/A | N/A |
| | Predicate
Comparison | The ComfortGuard Plus
Surgical Gown, i500
(i90-70xx-S1) meet the
predetermined
specifications. | The ComfortGuard
Surgical Gown, i500 (i90-
80xx-S1) meet the
predetermined
specifications. | N/A | N/A |

1:5 Conclusion of the tests

Based on the results of the biocompatibility and physical performance testing, the GRI Surgical Gowns are as safe and as performs as well as the predicate device for their intended use. The GRI Surgical Gowns are substantially equivalent to the predicate device.