K Number

Device Name

Surgical Gown

Manufacturer

Xianning Marveldas Protective Articles CO.,Ltd.

Date Cleared

2022-11-16

(439 days)

Product Code

FYA

Regulation Number

878.4040

Intended Use

Surgical gowns are sterile, disposable, and single use 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. This device is sterilized using Ethylene Oxide (EO) following the Validation and routine control under ANSI/AAMI/ISO 11135 (2014).

Device Description

The Sterile Level 4 Surgical Gown is 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. The proposed devices are single use and EO sterilized. The Sterile Level 4 Surgical Gowns are available in five models including S、 M、L、XL and XXL. The proposed surgical are constructed of a SMS nonwoven material (SMS+Film covering material+Velcro tape+Cuff material) and it is a kind of reinforced surgical gown and 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

K121152

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a surgical gown, a physical barrier, and the summary does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on material properties and barrier effectiveness.

Therapeutic

No
This device is a surgical gown, intended to protect from transfer of microorganisms and fluids, not to treat or cure a disease or condition.

Diagnostic

This device is a surgical gown, intended to protect personnel and patients from microorganisms and fluids, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical surgical gown made of SMS nonwoven material and other physical components, with performance studies focused on material properties and barrier protection. There is no mention of software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the surgical gown is for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic one.
Device Description: The description focuses on the physical construction and materials of the gown, designed for protection and sterility.
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.
Performance Studies and Metrics: The performance studies and key metrics are related to the physical properties of the gown (strength, penetration resistance, flammability, biocompatibility), not diagnostic accuracy or analytical performance.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical gown does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FYA

Device Description

The proposed surgical are constructed of a SMS nonwoven material (SMS+Film covering material+Velcro tape+Cuff material) and it is a kind of reinforced surgical gown and 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 as was similar to the predicate device. The test results demonstrated that the proposed subject device complies with the following standards:

AATCC 127: Hydrostatic pressure - Pass (>50 cm)
AATCC 42: Impact penetration - Pass (≤1g)
ASTM D 5034: Tensile Strength - Pass (Length(lbf): ≥37.6, Width(lbf): ≥24.2)
ASTM D 5733: Tearing strength - Pass (Length yarns torn(lbf):14.3, Width yarns torn(lbf):8.1)
ASTM D 1683: Seam strength - Pass (Arm Opening sleeves 23.5 lbf (FTS), 24.2lbf (FR), Shoulder 37.0 lbf (FR))
16 CFR Part 1610: Flammability of Textiles - Class 1
ASTM F1671: Bacteriophage Phi-X174 penetration - Pass (No penetration)
Biocompatibility:
- Cytotoxicity, ISO 10993-5:2009 - Pass (Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic)
- Irritation, ISO 10993-10:2002 - Pass (Under the conditions of the study, the proposed device extract was determined to be non-irritating)
- Sensitization, ISO 10993-10:2002 - Pass (Under the conditions of the study, the proposed device extract was determined to be non-sensitizing)

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

Not Found

Predicate Device(s)

K121152

Reference Device(s)

No reference devices were used in this submission.

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

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, 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.

November 16, 2022

Xianning Marveldas Protective Articles CO.,Ltd. % Salon Chen OS Engineer IMD Medical & Drug Technology Service Institutions Room 308, building 11, No. 23, Jinqu Road, Wanjiang Street Dongguan, Guangdong 523069 China

Re: K212812

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

Dear Salon Chen:

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 -S

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

Enclosure

Indications for Use

510(k) Number (if known) K212812

Device Name Surgical Gown

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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510(k) Summary (K212812)

1. Submitter Information

Company Name: Xianning Marveldas Protective Articles CO., Ltd.
Address: Guishan Road #30, Hi-New Tech Industrial, Xianning, Hubei P R C >
Phone: +86-1572066625
Contact Person (Title): Zhuxiaokang
E-mail: sale@marveldas.com
A Date of Preparation: November 10, 2022

2. Subject Device Information

Type of 510(k) submission: Traditional
Trade Name: Surgical Gown A
Common Name: Surgical Gown
Classification Name: Surgical Apparel
Model: S、M、L、XL、XXL
Classification Product Code: FYA
Requlation Number: 21 CFR 878.4040
Classification: Class II
Review Panel: General Hospital

3. Predicate Device Information:

510(k) Number: K121152
Predicate Device Name: Surgical Gown
Manufacturer: Jiangsu Guangda Medical Material Co., Ltd.
This predicate has not been subject to a design-related recall
No reference devices were used in this submission.

4. Application Correspondent

A Company Name: IMD Medical & Drug technology service institutions
Phone: +86-18613190779
Fax: +86-755-62809168
Contact Person(Title): Salon Chen (System engineer)
A E-mail: 33999439@qq.com
the address of application correspondent:308, Building 11, Zhongchuang Foreign Exchange Industrial Park, No. 23, Jinqu Road, Wanjiang Street, Dongguan, Guangdong, China

5. Device Description

use and EO sterilized. The Sterile Level 4 Surgical Gowns are available in five models including S、 M、L、XL and XXL.

The proposed surgical are constructed of a SMS nonwoven material (SMS+Film covering material+Velcro tape+Cuff material) and it is a kind of reinforced surgical gown and blue color.

6. Intended Use /Indications for Use

7. Comparison of technological characteristics with the Predicate

Elements of Comparison	Predicate Device	Subject Device	Comparison
Company Name	Jiangsu Guangda Medical
Material Co., Ltd.	Xianning Marveldas Protective
Articles CO., Ltd.	/
510(k) number	K121152	K212812	/
Device Name	Surgical Gown	Surgical Gown	/
Classification Product Code	FYA	FYA	same
Regulation	21 CFR 878.4040	21 CFR 878.4040	same
Classification Name	Surgical Apparel	Surgical Apparel	same
Class	2	2	same
Prescription or OTC	OTC	OTC	same

	Jiangsu Guangda's
Reinforced Surgical Gowns,
Model Number GD-SG-01,
are non-sterile, single use
surgical gowns intended to
protect surgical patients and
operating room personnel
from the transfer of
microorganisms, body fluids,
and particulate material.
This product may be
sterilized using Ethylene
Oxide (EO) following the
validation and routine control
under ANSI/AAMI/ISO	Surgical gowns are sterile,
disposable, and single
use devices that are intended
to be worn by operating roomprocedures to protect both the
surgical patient and the
operating room personnel from
transfer of microorganisms,
body fluids, and particulate
material. This device is
sterilized using Ethylene Oxide
(EO) following the Validation
and routine control under
ANSI/AAMI/ISO 11135 (2014).	same
Intended Use & Indications
for Use
Materials	SMS and PE+PP TWO layer
compound	SMS+Film covering
material+Velcro tape+Cuff	similar
Weight Per square(g)	45g/m²	45g/m²	same
Durability	Disposable	Disposable	same
Size	XL	S、M、L、XL、XXL	different
Color	Blue	Blue	same
Reinforced area	PE+PP two layer compound
protective reinforcement
with 100% white Terylene	double barrier non-woven fabric	same
Style	Reinforced	Reinforced	similar
Hydrostatic pressure:
AATCC 127	>20cm	>50 cm	different
Impact penetration:
AATCC 42	≤1	≤1	same
Tensile strength: ASTM
D5034	Passed	Length(lbf):37.6
Width(lbf):24.2	similar
Tearing strength: ASTM
D5733	Passed	Length yarns torn(lbf): 14.3
Width yarns torn(lbf): 8.1	similar
Seam strength: ASTM D1683	Pass	Arm Opening sleeves
23.5 lbf (FTS)
24.2lbf (FR)
Shoulder
37.0 lbf (FR)	similar
Flammability:
16CFR Part 1610	Class 1	Class 1	same
Sterilization method	Although sold non-sterile,
gown can be EO Sterilized	EO	same
Resistance to bacteriophage
penetration ASTM F1671	Level 4 per AAMI PB70	Level 4 per AAMI PB70	same
Biocompatibility	Cytotoxicity, ISO
10993-5:2009	Passed	ISO 10993-5; Under the
conditions of the study, the
proposed device extract was
determined to be non-cytotoxic
	Irritation, ISO
10993-10:2002	Passed	ISO 10993-10; Under the
conditions of the study, the
proposed device extract was
determined to be non-irritating
	Sensitization, ISO
10993-10:2002	Passed	ISO 10993-10; Under the
conditions of the study, the
proposed device extract was
determined to be non-
sensitizing
Test Method	Purpose	Acceptance
Criteria	Result
AATCC 127	Hydrostatic pressure	>50 cm	Pass
AATCC 42	Impact penetration	≤1g	Pass
ASTM D 5034	Tensile Strength	Length(lbf): ≥37.6
Width(lbf): ≥24.2	Pass
ASTM D 5733	Tearing strength	Length yarns
torn(lbf):14.3
Width yarns
torn(lbf):8.1	Pass
ASTM D 1683	Seam strength	Arm Opening
sleeves
23.5 lbf (FTS)
24.2lbf (FR)
Shoulder
37.0 lbf (FR)	Pass
16 CFR Part 1610	Flammability of Textiles	Class 1	Class 1
ASTM F1671	Bacteriophage Phi-X174
penetration	No penetration	Pass
Biocompatibility	Cytotoxicity, ISO
10993-5:2009	ISO 10993-5	ISO 10993-5; Under
the conditions of the
study, the proposed
device extract was
determined to be
non-cytotoxic
	Irritation, ISO 10993-10:2002	ISO 10993-10	ISO 10993-10;
Under the conditions
of the study, the
proposed device
extract was
determined to be
non-irritating
	Sensitization, ISO
10993-10:2002	SO 10993-10	ISO 10993-10;
Under the conditions
of the study, the
proposed device
extract was
determined to be
non-sensitizing

Analysis:

In term of key material composition, the surgical gowns are both constructed of a SMS nonwoven material. Other Secondary material is slightly different from those of the predicate device. The proposed device has been passed on the performance and biocompatibility. It is no effect on safety or efficacy.
Although the size is different from those of the predicate device. The proposed device has been passed on the performance testing. It is no effect on safety or efficacy.
In terms of general intended used, performance testing, material composition and configuration, hydrostatic pressure、tensile strength、tearing strength and seam strength are slightly different from those of the predicate device. The proposed device has been tested according to AATCC 127、ASTM D 5034、ASTM D 5733 and ASTM D 1683 respectively, and met the requirement of the standard.

8. Discussion of Non-Clinical Performance Tests Performed

Sterile Level 4 Surgical Gown

9. Summary of Clinical Test

No clinical study is included in this submission.

10.Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k), Surgical gowns is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K121152.