Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3

K221559 · Stringking · FYA · Feb 23, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K221559
• Device Name: Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3
• Applicant: Stringking
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Feb 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The StringKing Surgical Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The StringKing Surgical Gowns meet Level 3 and Level 4 requirements of ANSVAAMI PB 70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

Device Story

Disposable surgical gown; multi-layer nonwoven SMS polyolefin and film lamination in critical zones; single-layer SMS polyolefin in non-critical zones. Designed for donning/doffing with hook and loop neck tabs, belt ties, removable transfer accessory, and polyester wrist cuffs. Provided sterile. Used by healthcare professionals in surgical settings to provide liquid barrier protection (ANSI/AAMI PB 70:2012 Level 3 and Level 4).

Clinical Evidence

Bench testing only. No clinical data included. Testing included ANSI/AAMI PB 70:2012 liquid barrier performance, ASTM D5034 tensile strength, ASTM D5587 trap tear, ASTM D1683 seam strength, 16 CFR 1610 flammability, ASTM F1671 viral penetration, and ISO 10993 biocompatibility (cytotoxicity, sensitization, irritation).

Technological Characteristics

Materials: SMS polyolefin, film lamination, polyester cuffs. Standards: ANSI/AAMI PB 70:2012 (Level 3/4), ASTM D5034, ASTM D5587, ASTM D1683, 16 CFR 1610, ISO 10993-5/10/23/7. Sterilization: Ethylene Oxide (ISO 11135). Form factor: Disposable gown with hook/loop neck closure and belt ties.

Indications for Use

Indicated for healthcare professionals in health care facilities to protect patients and workers from transfer of microorganisms, body fluids, and particulate matter during surgical procedures.

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

• Surgical Gown (K202706)

Submission Summary (Full Text)

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February 23, 2023

StringKing Thomas Frasca Senior Partner 19100 S Vermont Avenue Gardena. California 90248

Re: K221559

Trade/Device Name: Disposable Surgical Gown-Level 3 Disposable Surgical Gown-Level 4 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: January 20, 2023 Received: January 20, 2023

Dear Thomas Frasca:

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

Sincerely.

# Bifeng Qian -S

Bifeng Oian, 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

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## Indications for Use

510(k) Number (if known) K221559

Device Name Disposable Surgical Gown - Level 3 Disposable Surgical Gown - Level 4

## Indications for Use (Describe)

The StringKing Surgical Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The StringKing Surgical Gowns meet Level 3 and Level 4 requirements of ANSVAAMI PB 70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# K221559 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

#### SUBMITTER 1.

StringKing 19100 S. Vermont Avenue Gardena. CA 90248 Tel: [phone] Fax: N/A

| Contact Person: | Tom Frasca |
|-----------------|--------------------------------------|
| Date Prepared: | February 23, 2023 |
| Prepared by: | Sharon Morrow, Regulatory Consultant |

#### ll. DEVICE

| 510(k): | K221559 |
|------------------------------|------------------------------------------------------------------------|
| Name of Device: | Disposable Surgical Gown, Level 4<br>Disposable Surgical Gown, Level 3 |
| Classification Name: | Disposable Surgical Gown |
| Regulation: | 21 CFR §878.4040 |
| Regulatory Class: | Class II |
| Product Classification Code: | FYA |

#### = PREDICATE DEVICE

Predicate Manufacturer Predicate Trade Name: Predicate 510(k):

B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD. Surgical Gown K202706

No reference devices were used in this submission.

#### IV. DEVICE DESCRIPTION

The Disposable Surgical Gown consists of a multi-layer nonwoven spunbond-meltblownspunbond (SMS) polyolefin & Film Lamination in the critical zones and a single layer of lighter, more breathable nonwoven SMS polvolefin in the non-critical zones. The StringKing Disposable Surgical Gown is designed for easy donning and doffing with hook and loop neck tabs, belt ties, removable transfer accessory, and polyester wrist cuffs. The StringKing Disposable Surgical Gown is one gown design that meets both Level 4 requirements of AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The gown will be marketed as a L3 gown as well as a L4 gown. The StringKing Disposable Surgical Gowns are single use, disposable medical devices that will be provided sterile.

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#### V. INDICATIONS FOR USE

The StringKing Disposable Surgical Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The StringKing Surgical Gowns meet Level 3 and Level 4 requirements of ANSI/AAMI PB 70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE

| Device | Subject Device<br>StringKing<br>Disposable<br>Isolation Gown<br>(K221559) | Predicate: B.J.ZH.F.<br>Panther Medical<br>Equipment Co., Ltd.<br>(K202706) | Justification for<br>Differences |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Manufacturer | StringKing | B.J.ZH.F. Panther Medical<br>Equipment | N/A |
| 510K Number | K221559 | K202706 | N/A |
| Product<br>Common Name | Disposable Surgical<br>Gown | Surgical Gown | Same |
| Product Code | FYA | FYA | Same |
| Classification | Class II (21 CFR<br>878.4040) | Class II (21 CFR<br>878.4040) | Same |
| Intended Use /<br>Indications for<br>Use | The StringKing<br>Disposable Surgical<br>Gown is a sterile, single<br>use surgical apparel<br>intended to be worn by<br>healthcare<br>professionals to help<br>protect both the patient<br>and the healthcare<br>worker from the transfer<br>of microorganisms,<br>body fluids and<br>particulate matter. The<br>StringKing Surgical<br>Gowns meet Level 3<br>and Level 4<br>requirements of<br>ANSI/AAMI PB 70:2012<br>Liquid barrier<br>performance and<br>classification of<br>protective apparel and<br>drapes intended for use | Surgical gowns are intended to<br>be worn by operating room<br>personnel during surgical<br>procedure to protect both the<br>surgical patient and the<br>operating room personnel from<br>transfer of microorganisms,<br>body fluids, and particulate<br>material.<br>Per ANSI/AAMI PB70:2012<br>Liquid barrier performance and<br>classification of protective<br>apparel and drapes intended for<br>use in health care facilities, the<br>surgical gowns met the<br>requirements for Level 3<br>classification. | Intended Use is the Same.<br>Subject Device also meets<br>Level 4 requirements |
| | in health care facilities. | | |
| Gown Sizes | Small, Medium,<br>Large, X-Large, 2X-<br>Large | Small, Medium, Large, X-<br>Large, XX-Large and XXX-<br>Large. | Similar; Predicate<br>offers XXX-Large |
| Material<br>Composition | SMS Reinforced<br>SMS/PE - gown<br>material and ties | SMS polypropylene<br>nonwoven + Polyester | Similar; |
| Design Features | Neck Closure: Hook<br>& Loop Tab<br>Belt: Ties<br>Cuffs: Knit<br>Transfer Tab | Neck Closure: not included in<br>510k Summary.<br>Belt: not listed in 510k<br>Summary<br>Cuffs: Knit | Similar |
| Color | Blue | Blue | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Sterile (EO) | Sterile (EO) and Bulk, non-<br>sterile | Similar; predicates<br>available bulk, non-<br>sterile |
| Use | Single Use,<br>Disposable | Single Use, Disposable | Same |
| ANSI/AAMI PB70 | Level 3 and Level 4 | Level 3 | Same ; Subject Device<br>also meets Level 4<br>requirements |
| Liquid Barrier<br>Performance<br>Classification<br>Properties | Device was tested in<br>accordance with<br>AAMI PB70:2012<br>and meets Level 4<br>and Level 3<br>requirements for<br>a surgical gown. | 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, the proposed<br>devices meet the requirements for<br>Level 3<br>classification. | Same |
| Flammability | Meets requirements<br>of Class 1 per 16<br>CFR 1610 | Class 1 per 16 CFR 1610 | Same |
| Non-barrier<br>properties | | Not specified in 510k summary | Same |
| Tensile Strength;<br>ASTM D5034 (Machine<br>Direction) | Meets requirements<br>of ASTM D5034:<br>$\ge$ 7lbf | | |
| Tensile Strength;<br>ASTM D5034 (Cross<br>direction) | Meets requirements<br>of ASTM D5034:<br>$\ge$ 7lbf | | |
| Trap Tear; ASTM<br>D5587 (Machine<br>Direction) | Meets requirements<br>of ASTM D5587:<br>$\ge$ 2.3lbf | | |
| Trap Tear; ASTM<br>D5587 (Cross<br>Direction) | Meets requirements<br>of ASTM D5587:<br>$\ge$ 2.3lbf | | |
| Seam Strength;<br>ASTM D1683 | Meets requirements<br>of ASTM D1683:<br>$\ge$ 7lbf | | |
| Biocompatibility | Meets requirements<br>of ISO 10993-5, ISO<br>10993-10, ISO<br>10993-23 (non-<br>cytotoxic, non-<br>irritant, non-<br>sensitizer) | Meets requirements of ISO<br>10993-5, ISO 10993-10<br>(non-cytotoxic, non-irritant, non-<br>sensitizer) | Same |
| Ethylene oxide<br>residuals | Meets requirements<br>of ISO 10993-7 | Meets requirements of<br>ISO 10993-7 | Same |
| Test Standard | Acceptance<br>Criteria | Results -<br>Proposed<br>Device -<br>StringKing<br>Disposable<br>Surgical Gown<br>(K221559) | Pass/Fail |
| ANSI/AAMI PB70:2012 | | Meets ANSI/AAMI<br>PB 70:2012 Level 3<br>and Level 4 Liquid<br>Barrier requirements | |
| Water Resistance<br>Hydrostatic Pressure<br>Test - AATCC 127:2017<br>(cm) | $\ge$ 50<br>cm | All samples passed<br>at $\ge$ 50 cm | Pass |
| Flammability of<br>Clothing Textiles - 16<br>CFR Part 1610 (a) | Class 1: $\ge$ 3.5 seconds | All samples passed at<br>$\ge$ 3.5 seconds | Pass |
| Durability<br>ASTM D-5034 | $\ge$ 7lbf | All samples passed at<br>greater than 7lbf | Pass |
| Tensile Strength<br>ASTM D-5034<br>Machine Direction<br>and Cross<br>Direction | $\ge$ 7lbf | All samples passed at<br>greater than 7lbf | Pass |
| Trap Tear ASTM D5587-<br>15<br>Machine Direction and<br>Cross Direction | ≥2.3lbf | All samples passed<br>at<br>≥2.3lbf | Pass |
| Water Resistance<br>Impact Penetration<br>Test AATCC 42 | ≤1.0<br>g | All samples passed at<br>≤1.0g | Pass |
| ASTM D1683<br>Seam Strength | ≥7lbf | All samples passed at<br>≥7lbf | Pass |
| ASTM F1671<br>Viral Penetration | Level 4: Blood and<br>viral<br>penetration<br>resistance<br>No<br>penetration at 2psi | All samples showed<br>no penetration at 2psi | Pass |
| Ethylene oxide residuals<br>ISO 10993-7 | EO <4mg*<br>ECH <9mg | EO residuals were not<br>detected ("ND") | Pass |

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# VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

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*Daily dose

## Sterilization & Shelf-life Testing

Sterilization validation according to ISO 11135; Shelf-life testing was conducted according to ASTM F1980-16 as well as ASTM F2096-11(2019) and ASTM F88/F88M-15.

## Biocompatibility Testing

| Biocompatibility Testing<br>Endpoints | Acceptance Criteria | Results | Pass/Fail |
|---------------------------------------|---------------------|---------|-----------|
| Cytotoxicity – ISO 10993-5 | ≤Grade 2 (mild) | Grade 0 | Pass |

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| Skin Sensitization- ISO 10993-<br>10 | Primary Irritation Index<br>0-0.4 — Negligible<br>0.5-1.9-Slight<br>2-4.9-Moderate 5-8-<br>Severe | 0.0 | Pass |
|--------------------------------------|---------------------------------------------------------------------------------------------------|-----|------|
| Skin Irritation - ISO 10993-23 | ≤1 on Magnusson and<br>Kligman Scale | 0.0 | Pass |

Clinical testing: Clinical Studies are not required for this device and therefore are not included in this submission.

## VIII. CONCLUSIONS

The conclusions drawn from the non-clinical tests demonstrate that the subject device in 510(k) submission K221559, the StringKing Surgical Gown is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K202706), manufactured by B.J.ZH.F. Panther Medical Equipment Co., Ltd.