Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and barrier protection of a surgical isolation gown, with no mention of AI or ML.

Therapeutic

No

Explanation: The device is a surgical isolation gown intended to protect healthcare personnel from the transfer of microorganisms, body fluids, and particulate material, not to treat any medical condition or disease.

Diagnostic

No

The device is a surgical isolation gown, which is a protective apparel intended to protect healthcare personnel from the transfer of microorganisms and body fluids. Its purpose is protective, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical surgical isolation gown made of materials like Polypropylene SMS non-woven and Polyethylene, with physical components like neck ties, waist belts, and elastic cuffs. It is a tangible, disposable medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the gown is for protecting healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
Device Description: The description focuses on the physical construction and materials of the gown, designed for protection.
Performance Studies: The performance studies described are related to the physical properties and barrier performance of the gown (flammability, hydrostatic pressure, tensile strength, etc.), not diagnostic accuracy or analytical performance.
Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical isolation gown does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Surgical Isolation Gown is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.

Product codes

FYC

Device Description

The Proposed device is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC and is a single use, disposable medical device provided non-sterile. The Surgical Isolation Gown is constructed of the neck tie, the waist belt, and elastic cuffs. The body fabric material is Polypropylene SMS non-woven, coated with Polyethylene. And all seams are reinforced by sealing tape of 100% Polyurethanes. The Surgical Isolation Gown is offered in blue with seven sizes ( S, M, L, XL, XXL, 3XL, 4XL).

The Surgical Isolation Gown has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3 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

Health care personnel in health care facilities. Not intended for use in the operating room.

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: Non-clinical tests including:

Biocompatibility (Cytotoxicity, Irritation, Sensitization)
Liquid Barrier Performance (Hydrostatic Pressure, Impact Penetration)
Flammability
Tensile Strength
Tearing Strength
Seam Strength
Linting
Evaporative Resistance

Sample Size: 3 non-consecutive lots, 32 samples/lot for certain tests (as indicated by '*' in comparison tables).

Key Results:

Flammability: Class I (for all 3 lots)
Liquid Barrier Performance (AATCC 127 Hydrostatic Pressure): All tested areas (Front, Back, Sleeve, Sleeve seam, Shoulder seam, Waistband seam) met Level 3 requirement (>50 cmH2O).
Liquid Barrier Performance (AATCC 42 Impact Penetration): All tested areas met Level 3 requirement (1.00 kPa.m²/W for all 3 lots.
Biocompatibility: Non-Cytotoxic, Non-Irritating, Non-Sensitizing.

The nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device identified. All test results meet the requirement of ASTM F2407-20 Standard Specification For Surgical Gowns Intended for Use in Healthcare Facilities, and meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities.

Key Metrics

Not Found (Specific numerical key metrics like AUC, MRMC, Sensitivity, Specificity, PPV, NPV are not applicable for this type of device and performance study.)

Predicate Device(s)

K190306

Reference Device(s)

K171535

Predetermined Change Control Plan (PCCP) - All Relevant Information

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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 20, 2022

Wuhan Zonsen Medical Products Co., Ltd Cynthia Ye General Manager No 8 Jinchao Road, Zhucheng Street, Xinzhou District Wuhan, Hubei 431000 China

Re: K212357

Trade/Device Name: Surgical isolation gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: November 16, 2021 Received: December 21, 2021

Dear Cynthia Ye:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

1

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K212357

Device Name Surgical Isolation Gown

Indications for Use (Describe)

The Surgical Isolation Gown is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.

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)

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3

510(K) Summary

510(k) Number: K212357 Revised date: January 17, 2022 A. Applicant: Wuhan Zonsen Medical Products Co., Ltd Address: No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan City, Hubei Contact Person: Cynthia Ye Tel: +86-27-82737771 Fax: +86- 27-82737772

Submission Correspondent: Primary contact: Cynthia Ye Tel: +86-27-82737771 Email: info@zonsenmed.com Secondary contact: Cynthia Ye Tel: +86-27-82737772 Email:Cynthia@zonsenmed.com

B. Device:

Trade Name: SURGICAL ISOLATION GOWN Common Name: ISOLATION GOWN Model(s): ZIG 1256

Regulatory Information Classification Name: Surgical Isolation Gown Classification: Class II Product code: FYC Regulation Number: 878.4040 Review Panel: Surgical Apparel

C. Predicate device:

K190306 AMD Ritmed AssureWear™ VersaGown AMD Medicom, Inc.

D. Reference device:

K171535 Surgical Isolation Gown Jingzhou Haixin Green Cross Medical Products Co., Ltd

E. Indications for use :

4

Wuhan Zonsen Medical Products Co., Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan City, Hubei

The Surgical Isolation Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.

F. Device Description:

The Proposed device is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC and is a single use, disposable medical device provided non-sterile. The Surgical Isolation Gown is constructed of the neck tie, the waist belt, and elastic cuffs. The body fabric material is Polypropylene SMS non-woven, coated with Polyethylene. And all seams are reinforced by sealing tape of 100% Polyurethanes. The Surgical Isolation Gown is offered in blue with seven sizes ( S, M, L, XL, XXL, 3XL, 4XL).

The Surgical Isolation Gown has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3 requirement.

| Comparison
Component | Proposed Device | Predicate Device | Reference Device | Comparis
on | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------------|
| Manufacturer | Wuhan Zonsen Medical
Products Co., Ltd | AMD Medicom, Inc. | Jingzhou Haixin Green
Cross Medical
Products Co., Ltd | / | |
| 510K number | K212357 | K190306 | K171535 | / | |
| Device name | Surgical isolation gown | AMD
Ritmed
AssureWear™ VersaGown | SURGICAL
ISOLATION GOWN | / | |
| Classification | Class II Device, FYC (21
CFR878.4040) | Class II Device, FYC (21
CFR878.4040) | Class II Device, FYC
(21CFR878.4040) | Same | |
| Intend use /
Indications
for use | The Surgical Isolation
Gown is intended to
protect health care patients
and health care personnel
from the transfer of
microorganisms, body
fluids and particulate
material. Not intended for
use in the operating room.
In addition, the Surgical
Isolation Gown meets the
requirements of an AAMI | AMD
Ritmed
AssureWear™ VersaGown
is intended to be worn by
healthcare personnel to
protect health care patients
and health care personnel
from the transfer of
microorganisms, body
fluids and particulate
material. AMD Ritmed
AssureWear™ VersaGown
is a single use, disposable | The Surgical Isolation
Gown is intended to
protect health care
patients and health care
personnel from the
transfer of
microorganisms, body
fluids and particulate
material. Not intended
for use in the operating
room. In addition, the
Surgical Isolation Gown | Same | |
| | | | | | |
| | Level 3 barrier protection
for an isolation gown per
ANSI/AAMI PB70:2012
Liquid Barrier
Performance
and
Classification of Protective
Apparel Drapes Intended
for Use in Health Care
Facilities. The Surgical
Isolation Gown is a single
use, disposable medical
device provided
non-sterile. | medical device provided
non-sterile
and
non-intended for use in
operating rooms. | meets the requirements
of an AAMI Level 3
barrier protection for an
isolation gown per
ANSI/AAMI PB70:2012
Liquid Barrier
Performance and
Classification of
Protective Apparel
Drapes Intended for Use
in Health Care Facilities
(ANSI/AAMI PB70).
The Surgical Isolation
Gown is a single use,
disposable medical
device provided
non-sterile. | | |
| Level
of
barrier
protection
AAMI PB70 | Level 3 | Level 3 | Level 3 | Same | |
| Material
composition | Polypropylene
non-woven + PE | SMS | PP SMS non-woven + PE | Polypropylene SMS non
woven | Same as
K190306 |
| Design | Elastic cuffs
Tie (neck)
Blue waist belt
Reinforced seams | Thumb loop
Elastic cuffs
Extended cuff
(Thumb loop)
Flexneck™
Tie (neck)
Straight sleeve
Inclined sleeve
Blue belt tie
Reinforced seams | Medical Tape Neck
Closure
White Belt Tie
Snap fastener | Similar to
K190306 | |
| Color | Blue | Blue | Yellow | Same as
K190306 | |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same | |
| Use | Single use; disposable | Single use; disposable | Single use; disposable | Same | |

G. Comparison with predicate device

Table1

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Wuhan Zonsen Medical Products Co., Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan City, Hubei

Table 2

Non-clinical Performance
Comparison Component	Proposed Device (K212357)	Predicate Device (K190306)	Reference Device (K171535)	Comparison
Basic weight ASTM D3776	$40\pm2$ g/m²	$39.97\pm1.61$ g/m²	Testing not	Similar
Non-clinical Performance
Comparison Component	Proposed Device
(K212357)	Predicate Device
(K190306)
(1.17 oz/yd² ± 0.05)	Reference Device
(K171535)
performed	Comparison
to
K190306
Liquid barrier
performance	AATCC 127
Hydrostatic
Pressure
( cmH2O )	Average:
Front: 160.29*
Back: 152.09*
Sleeve: 152.03*
Sleeve seam:
138.06*
Shoulder seam:
146.50*
Waistband seam:
72.19*	Chest:
109.34 ± 0.34
Sleeve seams:
110.67± 3.84
Belt attachments:
104 ± 5.19
Body/sleeve/belt
mean: 108 ±3.1	CHEST/BACK/S
LEEVE:
Mean = 69
Ind Min = 54
Ind Max = 84	Similar
to
K190306
	AATCC 42
Impact
Penetration
( g )	Front: 0.3 :
2.07; >0.5 : 1.97
Index for Particulate
Matter (IPM): 1.50
Inside:
Total linting >0.3 :
2.16; >0.5 : 2.00
Index for Particulate
Matter (IPM): 1.35	SIDE A:
OUTSIDE
TOTAL >0.3
1024
TOTAL >0.5
658
SIDE B: INSIDE
TOTAL >0.3
1066
TOTAL >0.5
697	Better
than
K171535
ASTM F1868-17 Evaporative
Resistance		>1.00 kPa.m²/W	Testing not
performed	Testing not
performed	/
Biocompatibility	Irritation ISO
10993-10	Under the condition
of the study, non
irritating	Under the condition
of the study, not an
irritant	The test was done
against
ISO10993-5 and
ISO10993-10. The	Same
	Sensitization
ISO 10993-10	Under the condition
of the study, non
sensitizing	Under the condition
of the study, not a
sensitizer	result indicates the
gown is	Same
	Cytotoxicity
ISO 10993-5	Under the condition
of the study, non-
cytotoxic	Under the condition
of the study, non-
cytotoxic	noncytotoxic,
non-irritating, and
non-sensitizing per
ISO 10993-1	Same

6

7

Note: * means the average results of 3 non-consecutive lots,32 samples/ lot.

H. Summary of Non-Clinical Test

The Surgical Isolation gowns were tested following below standards:

ISO10993-5 Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity; A
A ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities;
AATCC 42 Water Penetration Resistance: Impact Penetration Test; A
AATCC 127 Water Resistance: Hydrostatic Pressure Test; >
ASTM D5034-09 (Reapproved 2017) Test Method for Breaking Strength and Elongation of A Textile Fabrics (Grab Test) ;

8

Wuhan Zonsen Medical Products Co., Ltd No 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan City, Hubei

A ASTM D5733-99 Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure;
A ASTM D1683/ D 1683M-17(2018) Test methods for Failure in Sewn Seams of Woven Apparel Fabrics;
16 CFR 1610-2008 Standard for the Flammability of clothing textiles;
A ISO9073-10:2003 Textiles-Test methods for nonwovens-Part 10: Lint and other particles generation in the dry state;
A ASTM F1868-17 Test methods for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate.

Test Item	Requirement	Test results (Average, 32 samples/ lot)
Flammability 16 CFR Part
1610-2008	Class I	Lot1: Class I
Lot2: Class I
Lot2: Class I
AATCC 127 Hydrostatic Pressure
(cmH2O)	Level 3: >50	Lot1 Lot2 Lot3 Front 151.6 165.4 163.7 Back 142.8 158.4 154.4 Sleeve 148.5 153.4 153.9 Sleeve seam 149.8 133.5 130.7 Shoulder seam 155.3 141.2 143.2 Waistband d seam 99.5 59.1 58.3
		AATCC 42 Impact Penetration
(g)	Level 3:1.0 kPa·m2 /W
Lot2: >1.0 kPa·m2 /W
Lot3: >1.0 kPa·m2 /W

Table 4 -Biological Specifications:

Performance	Requirement	Results
Cytotoxicity
EN ISO10993-5	Non-Cytotoxic	PASS
Per the Biocompatibility Evaluation, the proposed device
is non-Cytotoxic.
Irritation
EN ISO 10993-10	Non-Irritating	PASS
Per the Biocompatibility Evaluation, the proposed device
is non-Irritating.
Sensitization
EN ISO 10993-10	Non-Sensitizing	PASS
Per the Biocompatibility Evaluation, the proposed device
is non-Sensitizing.

All the test results meet the requirement of ASTM F2407-20 Standard Specification For Surgical Gowns Intended for Use in Healthcare Facilities, and meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and

10

Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities.

I. Clinical Performance

Not applicable.

J. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device identified.