K Number

Device Name

Disposable Surgical Gown UM-148

Manufacturer

Unimax Medical Products Co., Ltd.

Date Cleared

2022-09-20

(99 days)

Product Code

FYA

Regulation Number

878.4040

Intended Use

The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.

Device Description

The proposed device Disposable Surgical Gown is model UM-148, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of polyester. The proposed device is available in sizes: S(120×135cm), M(125×140cm), L(130×145cm) and XL(135×150cm). This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and a blue color.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K212591

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on material properties and barrier performance, with no mention of AI or ML.

Therapeutic

No
The device is a surgical gown, which is a barrier to protect against microorganisms and body fluids, not a device used for therapy.

Diagnostic

This device, a disposable surgical gown, is described as protection against the transfer of microorganisms, body fluids, and particulate matter during surgical procedures, not for diagnostic purposes.

SaMD (Software as a Medical Device)

The device description clearly states the device is a physical surgical gown made of SMMS non-woven material and polyester, with specific dimensions and material properties. It is a tangible, disposable medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
Device Description and Intended Use: The description clearly states the device is a "Disposable Surgical Gown" intended to be worn by operating room personnel to protect against the transfer of microorganisms, body fluids, and particulate matter during surgical procedures. This is a barrier device used on the body, not a device used to test samples from the body.
Lack of IVD Characteristics: The description does not mention any testing of biological samples, reagents, analytical methods, or any other components typically associated with IVD devices.

The information provided describes a medical device used for personal protection and barrier function in a surgical setting, which falls under a different category of medical devices than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

FYA

Device Description

The proposed device Disposable Surgical Gown is model UM-148, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of polyester. The proposed device is available in sizes: S(120x135cm), M(125x140cm), L(130x145cm) and XL(135x150cm). This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.

The proposed devices are disposable medical devices and provided in sterile and a blue color.

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 / 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, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gown was assessed for performance using the following Standards and Test Methods: AAMI/ANSI PB70:2012, ASTM D5587-15, ASTM D5034-09 (2017), ASTM D1683M-17, AATCC 42-2013, ASTM F1868-17, AATCC 127-2014, CPSC 16 CFR Part 1610-2008, ISO 9073- 10:2003(E), ISO 10993-10: 2010, ISO 10993-5: 2009. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints.

Key Results:

AAMI/ANSI PB70:2012: Level 3
ASTM D5587-15 (Tearing Strength): MD: 45.5N, CD: 28.2N (Average result from 10 samples) - PASS (Acceptance Criteria: ≥10 N)
ASTM D5034-09 (2017) (Breaking Strength): MD: 145.4N, CD: 91.4N (Average result from 10 samples) - PASS (Acceptance Criteria: ≥30N)
ASTM D1683M-17 (Seam Strength): 52.6N (Average result from 10 samples) - PASS (Acceptance Criteria: ≥30N)
AATCC 42-2013 (Water Penetration Resistance): 0 g (Average result from 3 nonconsecutive batches) - PASS (Acceptance Criteria: ≤1.0 g)
Evaporative Resistance ASTM F1868-17: 2.36 Pa.m²/W. (Average result from 13 samples) - PASS (Acceptance Criteria: 50 cm)
CPSC 16 CFR Part 1610-2008 (Flammability): Class I (Average result from 5 samples) - PASS (Acceptance Criteria: Meets Class I requirements)
ISO 9073- 10:2003(E) (Lint and Other Particles Generation): 2.0 (Average result from 13 samples) - PASS (Acceptance Criteria: Log10(particle count)

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

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 logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 20, 2022

Unimax Medical Products Co., Ltd. % Jarvis Wu Consultant Shanghai SUNGO Management Consulting Company Limited. 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K221717

Trade/Device Name: Disposable Surgical Gown UM-148 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: August 12, 2022 Received: August 12, 2022

Dear Jarvis Wu:

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.

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 mediation-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.

Bifeng Qian M.D. 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

Indications for Use

Submission Number (if known)

K221717

Device Name

Disposable Surgical Gown (UM-148)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Unimax Medical Products Co., Ltd. No.1 Liansai Road, Changshangkou Town, Xiantao City, Hubei Province, P.R. China.

510(K) Summary K221717

Document prepared date: 2022/9/15

A. Applicant:

Name: Unimax Medical Products Co., Ltd. Address: No.1 Liansai Road, Changshangkou Town, Xiantao City, Hubei Province, P.R. China. Contact Person: Ning Haibo Tel: +86-027 82213162 Mail: sales@unimaxmedical.com

Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050

Email: fda.sungo@gmail.com

B. Device:

Trade Name: Disposable Surgical Gown Common Name: Surgical Gown Model(s): UM-148

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

C. Predicate device:

K212591

Disposable Surgical Gown

Suzhou JaneE Medical Technology Co., Ltd.

D. Intended use /Indications for Use:

Unimax Medical Products Co., Ltd. No.1 Liansai Road, Changshangkou Town, Xiantao City, Hubei Province, P.R. China.

E. Device Description:

The proposed devices are disposable medical devices and provided in sterile and a blue color.

F. Comparison with predicate device

Device	Predicate Device	Proposed Device	Comparison
Manufacturer	Suzhou JaneE Medical
Technology Co., Ltd.	Unimax Medical Products Co.,
Ltd.	-
510K number	K212591	K221717	-
Product Name	Disposable Surgical Gown	Disposable Surgical Gown	Same
Classification	Class II Device, FYA (21
CFR878.4040)	Class II Device, FYA (21
CFR878.4040)	Same
Intend use
/Indications for Use	The Disposable Surgical
Gowns are intended to be
worn by operating room
personnel during surgical
procedures to protect the
surgical patient and operating
room personnel from the
transfer of microorganisms,
body fluids and particulate
matter. This is a single use,
disposable device, provided
sterile.	The Disposable Surgical
Gowns are intended to be
worn by operating room
personnel during surgical
procedures to protect the
surgical patient and operating
room personnel from the
transfer of microorganisms,
body fluids and particulate
matter. This is a single use,
disposable device, provided
sterile.	Same
Material
Composition	Polyolefin (Polypropylene)
SMS nonwoven	Polyester
SMMS non-woven	Similar. No
effect on
safety or
efficacy.
Both passed
biocompatibility tests.
Sterility	Sterile	Sterile	Same
Use	Single Use; Disposable	Single Use; Disposable	Same
Color	Blue	Blue	Same
Size	M,L,XL,TL	S,M,L,XL	Similar. No
effect on
safety or
efficacy
Weight per
square(g)	Critical Area: 87.8g/m2
Non-Critical Area: 45.12g/m2	45g/m2	Similar. No
effect on
safety or
efficacy.
Both passed
performance
tests.
Tensile
(Breaking strength)	MD: 16.18 lbs (72N)
CD: 13.26 lbs (59N)	MD: 145.4N
CD: 91.4N	Similar. No
effect on
safety or
efficacy.
Both passed
performance
tests.
Tearing Strength	MD:22.25 lbs (99 N)
CD:18.20 lbs (81N)	MD: 45.5N
CD: 28.2N	Similar. No
effect on
safety or
efficacy.
Both passed
performance
tests.
Seam Strength	Sleeve Seam:68.3N
Side Seam:69.7N
Belt Seam:71N	52.6N	Similar. No
effect on
safety or
efficacy.
Both passed
performance
tests.
Hydrostatic
Pressure(cm)
AATCC-127	>50 cm	>50 cm	Same
Water Impact (g)
AATCC-42	≤1.0 g	≤1.0 g	Same
Liquid barrier
performance	Level 3 AAMI PB70	Level 3 AAMI PB70	Same
Flammability	Class I	Class I	Same
Linting	Log10(particle count) 50 cm	PASS
65~72 cm
(Average result from 3
nonconsecutive batches)
CPSC 16 CFR Part
1610-2008, Standard
for the Flammability of
clothing textiles	The test was performed
in accordance with 16
CFR Part 1610
Standard for the
Flammability of
Clothing Textiles to
evaluate the
flammability of the test
sample.	Meets Class I
requirements	PASS
Class I
(Average result from 5
samples)
ISO 9073- 10:2003(E)
Lint and Other Particles
Generation	The test was performed
in accordance with ISO
9073-10: 2003 Textiles-
Test Methods for
Nonwovens-Part 10:
Lint and Other Particles
Generation in the Dry
State to evaluate the
linting of the test
sample.	Log10(particle count)