Surgical Gown (Sterile), Surgical Gown (Non-sterile)

• K Number: K202706
• Device Name: Surgical Gown (Sterile), Surgical Gown (Non-sterile)
• Manufacturer: B.J.ZH.F.Panther Medical Equipment CO., LTD.
• Date Cleared: 2020-12-31 ( 106 days)
• Product Code: FYA
• Regulation Number: 878.4040

Intended Use

Surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.

Device Description

The proposed devices 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. The proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile two types. Both the sterile and non-sterile surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification.

Predicate Devices

K192290

Reference Devices

K172987

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/ML or related concepts.

Therapeutic

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

Diagnostic

No
The device is a surgical gown, which is designed to protect against the transfer of microorganisms, body fluids, and particulate material, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states the device is a physical, disposable surgical gown, not software.

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 surgical gowns are for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
• Device Description: The description reinforces the barrier function and mentions the material and classification based on liquid barrier performance. There is no mention of analyzing samples from the human body.
• Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances in samples
  • Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.

The device is a protective medical device used in a surgical setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.

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

FYA

Device Description

The proposed devices 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. The proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile two types. Both the sterile and non-sterile surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification.

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:

• 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
• AATCC 127:2017 Water Resistance: Hydrostatic Pressure Test
• AATCC 42:2017 Water Resistance: Impact Penetration Test
• ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State
• ASTM D1683/D1683M:2017/(R)2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics
• ASTM D5587:2019 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
• ASTM D5034:2017 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
• ASTM D737:2018 Standard Test Method for Air Permeability of Textile Fabrics
• ASTM F88/F88M:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials
• ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
• ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
• ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity
• ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization

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.

K192290

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.

K172987

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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

December 31, 2020

B.J.ZH.F.Panther Medical Equipment CO., LTD. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai. 200120 China

Re: K202706

Trade/Device Name: Surgical Gown (Sterile), Surgical Gown (Non-sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: November 23, 2020 Received: December 3, 2020

Dear Diana Hong:

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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For: Elizabeth F. Claverie-Williams, MS Acting 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202706

Device Name

Surgical Gown (Sterile), Surgical Gown (Non-sterile)

Indications for Use (Describe)

Surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.

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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510(k) Summary K202706

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K202706

• 1. Date of Preparation: 12/30/2020
• 2. Sponsor Identification

B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD.

Floor 3, Building 1, 28 Huoju Street, Changping Science and Technology Park, Changping District, 102200 Beijing, China

Establishment Registration Number: 3008388437

Contact Person: Wenyue Han Position: International Regulatory Affair Tel: [phone] Fax: [phone] Email: [e-mail]

• 3. Designated Submission Correspondent
     Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
• 4. Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
     Tel: [phone], Fax: [phone] Email: [e-mail]

• ર. Identification of Proposed Device
  Trade Name: Surgical Gown (Sterile), Surgical Gown (Non-sterile) Common Name: Surgical Gown

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510(k) Summary

Regulatory Information

Classification Name: Gown, Surgical Classification: II; Product Code: FYA; Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital;

Indication for use:

Surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.

Device Description:

The proposed devices 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. The proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile two types. Both the sterile and non-sterile surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification.

Identification of Predicate Device 6.

510K Number: K192290 Product Name: 50g SMS Standard Surgical Gown; 45g SMS Surgical Gown with Reinforcement; 68g BVB Surgical Gown;

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68g BVB Splicing Surgical Gown

7. Identification of Reference Device

510(k) Number: K172987 Product Name: Surgical Gown

8. Technological Characteristic Comparison Tables.

Item	Subject Device K202706	Predicate Device K192290	Reference Device K172987	Remark
Product Code	FYA	FYA	FYA	Same
Regulation
No.	21CFR 878.4040	21CFR 878.4040	21CFR 878.4040	Same
Class	II	II	II	Same
Indication for
Use	Surgical gowns are intended
to be worn by operating
room personnel during
surgical procedure to protect
both the surgical patient and
the operating room
personnel from transfer of
microorganisms, body
fluids, and particulate
material.
Per ANSI/AAMI PB70:2012
Liquid barrier performance
and classification of
protective apparel and
drapes intended for use in
health care facilities, the
surgical gowns met the
requirements for Level 3
classification.	Surgical gown is intended to
be worn by operating room
personnel during surgical
procedure to protect both the
surgical patient and the
operating room personnel
from transfer of
microorganisms, body
fluids, and particulate
material. Per ANSI/AAMI
PB70:2012 Liquid barrier
performance and
classification of protective
apparel and drapes intended
for use in health care
facilities, SMS Standard
Surgical Gown and SMS
Surgical Gown with
Reinforcement met the
requirements for Level 3
classification; BVB Surgical
Gown and BVB Splicing
Surgical Gown met the
requirements for Level 4
classification.	Surgical gown is intended to
be worn by operating room
personnel during surgical
procedure to protect both the
surgical patient and the
operating room personnel
from transfer of
microorganisms, body fluids,
and particulate material.
Per ANSI/AAMI PB70:2012
Liquid barrier performance
and classification of
protective apparel and drapes
intended for use in health
care facilities, the AG series
surgical gowns met the
requirements for Level 3
classification.	Similar
Style	Non-reinforced	Non-reinforced/Reinforced	Non-reinforced/Reinforced	Similar
Durability	Disposable	Disposable	Disposable	Same

Table 1 Technological Characteristic Comparison

Page 3 of 5

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Color	Blue	Blue	Blue	Same
Labeling	Conform with 21CFR Part
801	Conform with 21CFR Part
801	Conform with 21CFR Part
801	Same

Item	Subject Device K202706	Predicate Device K192290	Reference Device K172987	Remark
Weight
per
square (g)	55g/m²	50g/m², 45g/m², 68g/m²	44g/m²	Similar
Size	S, M, L, XL, XXL, XXXL	M, L, XL, XXL, XXXL,
XXXL-XLONG	XL	Similar
Flammability	Class I	Class I	Class I	Same
Hydrostatic
pressure	>50 cm	>50 cm	>50 cm	Same
Water impact	≤1.0 g	≤1.0 g	≤1.0 g	Same
Breaking
strength	>20N	>20N	>20N	Same
Tearing
strength	>20N	>20N	>30N	Similar
Linting	Log1030 ft³/min/ft²	>15cm³/s/cm²
(29 ft³/min/ft²)	>30 ft³/min/ft²	Similar
Material	SMS polypropylene
nonwoven + Polyester	SMS nonwoven, Laminated
material, white knitted cuff, white
spun-bond, and BVB	SMS
polypropylene
nonwoven	Similar
Level	Level 3 per AAMI PB 70	Level 3, Level 4 per AAMI
PB 70	Level 3 per AAMI PB 70	Similar
Biocompatibility
Cytotoxicity	No Cytotoxicity	No Cytotoxicity	No Cytotoxicity
Irritation	No Irritation	No Irritation	No Irritation	Same
Sensitization	No Sensitization	No Sensitization	No Sensitization
Sterile	Sterile/Non-sterile	Sterile	Non-sterile	Similar

Table 2 Technological Characteristic Comparison

9. Non-Clinical Test Conclusion

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:

• 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;

• AATCC 127:2017 Water Resistance: Hydrostatic Pressure Test; >
• ア AATCC 42:2017 Water Resistance: Impact Penetration Test;

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• ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;

• ASTM D1683/D1683M:2017/(R)2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics;

• ASTM D5587:2019 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;

• ASTM D5034:2017 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);

• ASTM D737:2018 Standard Test Method for Air Permeability of Textile Fabrics;

• ASTM F88/F88M:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;

• ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;

• ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals:

• ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity;

• ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;

10. Clinical Test Conclusion

No clinical study is included in this submission.

11. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device.