Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a physical surgical gown and its material properties and performance testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.

Therapeutic

No

Explanation: The device is a surgical gown intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to treat or cure a medical condition.

Diagnostic

No
The device is a surgical gown, which is a protective apparel. Its intended use is to protect patients and personnel from the transfer of microorganisms, body fluids, and particulate material, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device is a surgical gown, which is a physical product made of materials like SMS and film lamination, not software. The description details its physical construction, materials, and performance testing related to barrier properties and physical strength.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
Device Description: The description details the physical construction and materials of a surgical gown.
Lack of Diagnostic Elements: There is no mention of any components, reagents, or processes that would be used to perform a diagnostic test on a sample from the human body.
Performance Studies: The performance studies focus on physical properties, barrier performance, biocompatibility, and flammability – all relevant to a protective garment, not a diagnostic device.

IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical gown does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended 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.

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

FYA

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 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.

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

surgical patients and operating room personnel

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)

Study Type: Biocompatibility Testing
Sample Size: Not specified (refers to "the device")
Key Results: Tested 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.

Study Type: Flammability Test
Sample Size: Not specified
Key Results: Tested and met Class 1 requirement per 16 CFR Part 1610 (2014) Flammability.

Study Type: Liquid Barrier Performance Classification Properties - Critical Zones (ASTM F1671-13 Viral Penetration)
Sample Size: Results obtained from three independent Lots
Key Results:
A1: Base Material: PASS
A2: Tie Attachment: PASS
B1: Lower Sleeve Seam: PASS
B2: Upper Sleeve Seam: PASS
AQL=4% (alpha=.05)
RQL=20% (beta=0.10)
n=32; Acc=3; Rej=4

Study Type: Liquid Barrier Performance Classification Properties - Non-Critical Zone (AATCC 42-2013 Impact Penetration)
Sample Size: Results obtained from Three Lots
Key Results:
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)
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)
Meets PB70 level 1 requirements at Non-Critical Zones.

Study Type: Physical Properties - Basis Weight (ASTM D3776 (2009))
Sample Size: Results obtained from Three Lots
Key Results:
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)
Meets 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)

Study Type: Physical Properties - Grab Tensile (ASTM D5034-09 (2013))
Sample Size: Results obtained from Three Lots
Key Results:
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)
Meets 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

Study Type: Physical Properties - Trapezoid Tear (ASTM D5587 (2014))
Sample Size: Results obtained from Three Lots
Key Results:
Critical Zone Body/Sleeve Material MD: 57.3N (42.8, 73.2)
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)
Back Material MD: 20.7N (14.4, 28.4)
Back Material CD: 33.3N (24.9, 46.1)
Meets GRI Specifications: Critical Zone Body/Sleeve Material MD: Mean MD >= 20N; Critical Zone Body/Sleeve Material CD: Mean CD >= 40N; Non-Critical Zone Body/Sleeve Material MD: Mean MD >= 10N; Non-Critical Zone Body/Sleeve Material CD: Mean CD >= 20N; Back Material MD: Mean MD >= 10N; Back Material CD: Mean CD >= 20N

Study Type: Physical Properties - Seam Strength (ASTM D1683 (2007))
Sample Size: Results obtained from Three Lots
Key Results:
Outer Sleeve Seam: 47.4N (21.0, 60.2)
Inner Sleeve Seam: 90.4N (75.2, 106.0)
Meets GRI Specifications: Outer Sleeve seam: Min >=20N; Inner Sleeve seam: Min >=50N

Overall Conclusion: Based on the results of the biocompatibility and physical performance testing, the GRI ComfortGuard Surgical Gown, i600, Film Reinforced is as safe and as effective, and as the predicate device for its indications for use. The ComfortGuard Surgical Gown, i600, Film Reinforced is 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.

Kimberly-Clark ULTRA Film-Reinforced Surgical Gown(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

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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."

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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)

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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.

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Image /page/5/Picture/0 description: The image contains the logo for GRI, which stands for Global Resources International. The logo features the letters 'gri' in a bold, sans-serif font, with the 'i' having a curved line above it, resembling a check mark or a stylized accent. Below the letters, the words 'Global Resources International' are written in a smaller font size.

Product Codes covered in this submission 1.3

Table C 1 Product List

Product List
Product Name	Model Code without
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

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Catalog #
Sterile		Non-Sterile
Without Thumb-hook	With Thumb-hook	Without Thumb-hook	With Thumb-hook	Model Description	Size
i90-8200-S1	i90-8200T-S1	i90-8200	i90-8200T	ComfortGuard Surgical Gown, i600, Film Reinforced	S
i90-8210-S1	i90-8210T-S1	i90-8210	i90-8210T	ComfortGuard Surgical Gown, i600, Film Reinforced	M
i90-8220-S1	i90-8220T-S1	i90-8220	i90-8220T	ComfortGuard Surgical Gown, i600, Film Reinforced	L
i90-8230-S1	i90-8230T-S1	i90-8230	i90-8230T	ComfortGuard Surgical Gown, i600, Film Reinforced	XL
i90-8240-S1	i90-8240T-S1	i90-8240	i90-8240T	ComfortGuard Surgical Gown, i600, Film Reinforced	XXL
i90-8222-S1	i90-8222T-S1	i90-8222	i90-8222T	ComfortGuard Surgical Gown, i600, Film Reinforced	L-XLONG
i90-8232-S1	i90-8232T-S1	i90-8232	i90-8232T	ComfortGuard Surgical Gown, i600, Film Reinforced	XL-XLONG
i90-8242-S1	i90-8242T-S1	i90-8242	i90-8242T	ComfortGuard Surgical Gown, i600, Film Reinforced	XXL-XLONG
i90-8224-S1	i90-8224T-S1	i90-8224	i90-8224T	ComfortGuard Surgical Gown, i600, Film Reinforced	A-frame, L-XLONG
i90-8234-S1	i90-8234T-S1	i90-8234	i90-8234T	ComfortGuard Surgical Gown, i600, Film Reinforced	A-frame, XL-XLONG

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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

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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

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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) | | |
| | | Back Material MD:
20.7N (14.4, 28.4) | | |
| | | Back Material CD:
33.3N (24.9, 46.1) | | |
| | ASTM D5587 (2014)
Trapezoid Tear (Newton)
GRI Specifications | Critical Zone Body/Sleeve Material MD:
Mean MD ≥ 20N | N/A | N/A |
| | | Critical Zone Body/Sleeve Material CD:
Mean CD ≥ 40N | | |
| | | Non-Critical Zone Body/Sleeve Material MD:
Mean MD ≥ 10N | | |
| | | Non-Critical Zone Body/Sleeve Material CD:
Mean CD ≥ 20N | | |
| | | Back Material MD:
Mean MD ≥ 10N | | |
| | | Back Material CD:
Mean CD ≥ 20N | | |
| | | | | |
| 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 D1683 (2007)
Seam Strength
(Newton)
Test Results
Mean (Min, Max)
(Results obtained from
Three Lots) | Outer Sleeve Seam:
$47.4N$ (21.0, 60.2)

Inner Sleeve seam: Min ≥50 $N$ | N/A | N/A |
| | Predicate Comparison | The ComfortGuard Surgical Gown, i600, Film
Reinforced (i90-82xx-S1) meet the
predetermined specifications. | N/A | N/A |

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14

Image /page/14/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 swoosh above the "i". Below the letters is the text "Global Resources International" in a smaller font. The logo is simple and modern, and the use of blue and black gives it a professional look.

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

15

Image /page/15/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 swoosh above the "i". Below the letters, the words "Global Resources International" are written in a smaller font. The logo is simple and modern, and it conveys a sense of global reach and expertise.

Liquid Barrier Performance Classification Properties- Back (cont.)

16

Image /page/16/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 blue crescent shape above it. Below the letters, the words "Global Resources International" are written in a smaller, sans-serif font.

Physical Properties

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17

Image /page/17/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 in blue. Below the letters, the words "Global Resources International" are written in a smaller, sans-serif font.

Physical Properties (cont.)

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18

Image /page/18/Picture/0 description: The image shows the logo for Global Resources International (GRI). The logo consists of the letters "gri" in a stylized, italicized font, with a blue arc above the "i". Below the letters, the words "Global Resources international" are written in a smaller font.

Physical Properties (cont.)

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19

Image /page/19/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 "i" having a curved extension above it. Below the letters, the words "Global Resources International" are written in a smaller, sans-serif font.

Physical Properties (cont.)

1.2 Conclusion of the tests

Based on the results of the biocompatibility and physical performance testing, the GRI ComfortGuard Surgical Gown, i600, Film Reinforced is as safe and as effective, and as the predicate device for its indications for use. The ComfortGuard Surgical Gown, i600, Film Reinforced is substantially equivalent to the predicate device.