Disposable Surgical Gown
Device Facts
| Record ID | K210510 |
|---|---|
| Device Name | Disposable Surgical Gown |
| Applicant | Shandong Zhushi Pharmaceutical Group Co., Ltd. |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Aug 12, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The Disposable Surgical Gown is 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 material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Surgical Gowns are single use, disposable medical devices, provided sterile.
Device Story
Disposable surgical gown; worn by operating room personnel during surgical procedures; provides AAMI Level 3 barrier protection against microorganisms, body fluids, and particulate material. Constructed from polyolefin (polypropylene) SMS nonwoven fabric; features collar, body, sleeves with polyester elastic cuffs, and ties. Back is full opening; neck and waist are laced; assembly via heat sealing and sewing. Provided sterile; single-use. Protects both patient and personnel by preventing transfer of contaminants. Performance verified via bench testing against AAMI PB70:2012 standards.
Clinical Evidence
No clinical data. Bench testing only. Device performance validated against AAMI PB70:2012, ASTM F2407-06, AATCC 42, AATCC 127, ASTM D5034, ASTM D5587, ASTM D1683, ASTM F1868, ISO 9073-10, 16 CFR 1610, USP <85>, and ISO 11737-2. Biocompatibility testing confirmed no cytotoxicity, irritation, or sensitization.
Technological Characteristics
Material: Polyolefin (polypropylene) SMS nonwoven. Barrier: AAMI Level 3 per ANSI/AAMI PB70:2012. Sterilization: Ethylene Oxide (EO). Standards: ASTM F2407-06, AATCC 42, AATCC 127, ASTM D5034, ASTM D5587, ASTM D1683, ASTM F1868, ISO 9073-10, 16 CFR 1610, USP <85>, ISO 11737-2. Form factor: Disposable gown with elastic cuffs, laced neck/waist, full back opening.
Indications for Use
Indicated for operating room personnel during surgical procedures to provide AAMI Level 3 barrier protection against microorganisms, body fluids, and particulate material.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Cardinal Health™ Non-Reinforced Surgical Gown (K170762)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.
August 12, 2021
Shandong Zhushi Pharmaceutical Group Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K210510
Trade/Device Name: Disposable Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: May 12, 2021 Received: May 12, 2021
#### Dear Boyle Wang:
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 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
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) K210510
Device Name Disposable Surgical Gown
#### Indications for Use (Describe)
The Disposable Surgical Gown is 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 material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Surgical Gowns are single use, disposable medical devices, provided 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)
#### 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."
{3}------------------------------------------------
# 510(k) Summary
# K210510
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
### 1.0 Submitter's information
Name: Shandong Zhushi Pharmaceutical Group Co., Ltd Address: No.6 Shande Road, Shan County, Heze City, Shandong, China Contact: Mr. Junhui Zhu Phone Number: 86-530-7150111 Fax number: 86-530-7150111 Date of Preparation: Aug.01, 2021
## Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
#### 2.0 Device information
Trade name: Disposable Surgical Gown Common name: Surqical qown Classification name: Gown, Surgical Model(s): XS, S, M, L, XL, XXL, XXXL, XXXXL
# 3.0 Classification
Production code: FYA Regulation number: 21CFR 878.4040 Classification: Class II Surgical apparel Panel:
#### 4.0 Predicate device information
Manufacturer: Cardinal Health 200, LLC Device: Cardinal Health™ Non-Reinforced Surgical Gown 510(k) number: K170762
#### 5.0 Intended Use/Indication for Use Statement
{4}------------------------------------------------
The Disposable Surgical Gown is 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 material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Surgical Gowns are single use, disposable medical devices, provided sterile.
### 6.0 Device description
The Disposable Surgical Gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of polyester elastic closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown
| Table 3 - General Comparison | | | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Item | Proposed device | Predicated device | Remark |
| Product Code | FYA | FYA | Identical |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Identical |
| Class | II | II | Identical |
| Product name | Disposable Surgical Gown | Cardinal Health™ Non-Reinforced Surgical Gown | Similar |
| 510(k) No. | K210510 | K170762 | Different |
| Models | XS, S, M, L, XL, XXL, XXXL, XXXXL | M-S, M, L, XL, XXL | Similar |
| Intended<br>Use/Indications for<br>Use | The Disposable Surgical Gown is<br>intended to be worn by operating<br>room personnel during surgical<br>procedures to protect the surgical<br>patient and operating room<br>personnel from the transfer of<br>microorganisms, body fluids and<br>particulate material. In addition, this<br>surgical gown meets the<br>requirements of AAMI Level 3<br>barrier protection for a surgical gown<br>per ANSI/AAMI PB70:2012 Liquid<br>barrier performance and<br>classification of protective apparel<br>and drapes intended for use in<br>health care facilities (AAMI PB70).<br>The Disposable Surgical Gowns are<br>single use, disposable medical<br>devices, provided sterile. | Cardinal Health™<br>Non-Reinforced Surgical Gown<br>is intended to be worn by<br>operating room personnel<br>during surgical procedures to<br>protect the surgical patient and<br>operating room personnel from<br>the transfer of microorganisms,<br>body fluids and particulate<br>material. In addition, this<br>surgical gown meets the<br>requirements of AAMI Level 3<br>barrier protection for a surgical<br>gown per ANSI/AAMI<br>PB70:2012 Liquid barrier<br>performance and classification<br>of protective apparel and drapes<br>intended for use in health care | Similar |
#### 7.0Technological Characteristic Comparison Table
{5}------------------------------------------------
| | | facilities (AAMI PB70). The | |
|--------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------|-----------|
| | | Cardinal Health™ Non- | |
| | | Reinforced Surgical Gowns are | |
| | | single use, disposable medical | |
| | | devices; provided sterile and | |
| | | non-sterile. | |
| Composite | Neck Closure: Hook and Loop<br>Belt Ties Knit Cuffs<br>Transfer Tab | Neck Closure: Hook and Loop<br>Belt Ties Knit Cuffs<br>Transfer Tab | Identical |
| Material | Polyolefin (Polypropylene) SMS<br>nonwoven | Polyolefin (Polypropylene) SMS<br>nonwoven | Identical |
| Color | Blue | Blue | Identical |
| Sterility | Sterile | Non-Sterile and sterile | * Gap 1 |
| Sterilization method | EO | EO | Identical |
| Shelf life | 2 years | No identified | * Gap 2 |
| Single Use | Yes | Yes | Identical |
| Impact Penetration | <0.1g | 0.0-0.10 g | Similar |
| Hydrostatic<br>Resistance | >70 cm for critical zone | 65-92 cm | * Gap 3 |
| Tensile strength | Machine direction mean: 21.95 lbf;<br>Cross direction mean: 14.41 lbf. | MD mean: 21.57 lbf; CD mean:<br>13.6 lbs | * Gap 4 |
| Tear resistance | Fabric direction A mean: 5.09 lbf;<br>Fabric direction B mean: 3.10 lbf; | MD mean: 3.47 lbf; CD mean:<br>5.63 lbs | * Gap 5 |
| Flame spread | Class 1, Non Flammable | Class 1, Non Flammable | Identical |
| Resistance to blood<br>and liquid<br>penetration | Level 3 per PB70 | Level 3 per PB70 | Identical |
| Cytotoxicity | Under the condition of the test, no<br>potential cytotoxicity | Under the condition of the test,<br>no potential cytotoxicity | Identical |
| Irritation<br>Sensitization | Under the condition of the test, no<br>irritation and sensitization | Under the condition of the test,<br>no irritation and sensitization | Identical |
#### * Gap analysis:
Gap 1: the proposed device is provided sterile, the predicate device has two types sterile and non sterile, this difference does not create additional risks to the device. Gap 2, the predicate device was not claimed clear shelf life, while the proposed device defined 2 years, the proposed device performed its shelf life study and verified its 2 years shelf life, the difference does not raise additional risk for safety and effectiveness. Gap 3-5, the two devices have some little deviation in product performance, but the difference in the performance test result does not raise additional questions for safety and effectiveness.
#### 8.0 Non-Clinical Test Conclusion
The proposed device was tested and conformed to the related recognized standards and the requirements stated in the "Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes" dated on August, 1993.
{6}------------------------------------------------
Based on the 6-180 ASTM F2407-06 (Reapproved 2013), the subject device has been conducted the test as following:
AATCC 42-2013 Water Resistance: Impact Penetration Test
AATCC 127-2014 Water Resistance: Hydrostatic Pressure Test
ASTM D5034-09(2017) Standard Test Method for Breaking Strength and Elongation of Texile Fabrics (Grab Test)
ASTM D5587-15(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
ASTM D1683-17(2018) Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
ASTM F1868-17(2017) Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
ISO 9073-10:2003 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state
16 CFR Part 1610(a) Standard for The Flammability of Clothing Textiles
USP42-NF37 <85> Bacterial Endotoxins Test
ISO 11737-2:2019 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
| Test<br>Methodology | Purpose | Acceptance Criteria | Results |
|---------------------|---------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| AATCC 42 | Impact<br>Penetration | Level 3, ≤1.0g | <0.1g |
| AATCC 127 | Hydrostatic<br>Resistance | Level 3, ≥50cm | >70 cm for critical zone |
| ASTM D5034 | Tensile strength | Machine direction mean:<br>≥18 lbf;<br>Cross direction mean:<br>≥12 lbf. | Machine direction mean:<br>21.95 lbf;<br>Cross direction mean: 14.41<br>lbf. |
| ASTM D5587 | Tear resistance | Farbic direction A mean:<br>≥4.0 lbf;<br>Farbic direction B mean:<br>≥2.5 lbf; | Farbic direction A mean:<br>5.09 lbf;<br>Farbic direction B mean:<br>3.10 lbf; |
| ASTM D1683 | Seam strength | Shoulder: ≥8.5 lbf;<br>Arm opening: ≥5.5 lbf;<br>Sleeve: ≥8.5 lbf; | Shoulder: 10.8 lbf;<br>Arm opening: 6.4 lbf;<br>Sleeve: 10.2 lbf; |
| ISO 9073-10 | Side A (outside) | Index for Particulate<br>Matter (IPM): ≤2.5 | Index for Particulate Matter<br>(IPM): 2.25 |
| | Side B (inside) | Index for Particulate<br>Matter (IPM): ≤3.0 | Index for Particulate Matter<br>(IPM): 2.85 |
| | Side A&B | Index for Particulate<br>Matter (IPM): ≤3.0 | Index for Particulate Matter<br>(IPM): 2.64 |
| ASTM 2407 | Evaporative<br>resistance | Critical zone: ≥850<br>g/m²/24hrs<br>Non-critical zone: ≥850<br>g/m²/24hrs | Critical zone: 953.8<br>g/m²/24hrs<br>Non-critical zone: 930.2<br>g/m²/24hrs |
| 16 CFR Pat | Flame spread | Class 1, Non Flammable | Class 1, Non Flammable |
{7}------------------------------------------------
| 1610 | | | |
|----------------------|------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|
| USP42-NF37<br><85> | Bacterial<br>Endotoxins | < 20EU | < 20EU |
| ISO 11737-<br>2:2019 | SAL | $10^{-6}$ | $10^{-6}$ |
| Cytotoxicity | Biocompatibility-<br>cytotoxicity | Under the condition of<br>the test, no potential<br>cytotoxicity | Under the condition of the<br>test, no potential<br>cytotoxicity |
| Irritation | Biocompatibility-<br>irritation | Under the condition of<br>the test, no irritation | Under the condition of the<br>test, no irritation |
| Sensitization | Biocompatibility-<br>sensitization | Under the condition of the<br>test, no sensitization | Under the condition of the<br>test, no sensitization |
### 9.0 Clinical Test Conclusion
No clinical study implemented for the Disposable Surgical Gown.
#### 10.0 Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210510, the Disposable Surgical Gown is as safe, as effective, and performs as well as or better than the legally marketed predicate device K170762.
