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.

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.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Test Standard	Acceptance Criteria	Reported Device Performance	Pass/Fail
ANSI/AAMI PB70:2012 (Overall classification)	Meets Level 3 and Level 4 Liquid Barrier Requirements	Meets ANSI/AAMI PB 70:2012 Level 3 and Level 4 Liquid Barrier requirements	Pass
Water Resistance Hydrostatic Pressure Test - AATCC 127:2017 (cm)	$\ge$ 50 cm	All samples passed at $\ge$ 50 cm	Pass
Flammability of Clothing Textiles - 16 CFR Part 1610 (a)	Class 1: $\ge$ 3.5 seconds	All samples passed at $\ge$ 3.5 seconds	Pass
Durability ASTM D-5034	$\ge$ 7 lbf	All samples passed at greater than 7 lbf	Pass
Tensile Strength ASTM D-5034 Machine Direction and Cross Direction	$\ge$ 7 lbf	All samples passed at greater than 7 lbf	Pass
Trap Tear ASTM D5587-15 Machine Direction and Cross Direction	$\ge$ 2.3 lbf	All samples passed at $\ge$ 2.3 lbf	Pass
Water Resistance Impact Penetration Test AATCC 42	$\le$ 1.0 g	All samples passed at $\le$ 1.0 g	Pass
ASTM D1683 Seam Strength	$\ge$ 7 lbf	All samples passed at $\ge$ 7 lbf	Pass
ASTM F1671 Viral Penetration	Level 4: No penetration at 2 psi	All samples showed no penetration at 2 psi	Pass
Ethylene oxide residuals ISO 10993-7	EO <4mg, ECH <9mg	EO residuals were not detected ("ND")	Pass
Cytotoxicity – ISO 10993-5	$\le$ Grade 2 (mild)	Grade 0	Pass
Skin Sensitization- ISO 10993-10	Primary Irritation Index 0-0.4 (Negligible)	0.0	Pass
Skin Irritation - ISO 10993-23	$\le$ 1 on Magnusson and Kligman Scale	0.0	Pass

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific sample sizes for each individual test. It generally uses phrases like "All samples passed," indicating that a sufficient number of samples were tested to meet the requirements of the respective standards.

The data provenance is from non-clinical testing conducted according to recognized international and national standards (e.g., ANSI/AAMI PB70:2012, AATCC, ASTM, ISO, CFR). The testing was for the StringKing Disposable Surgical Gown. The document does not specify the country of origin of the testing facilities, but the standards are international. This is retrospective in the sense that the studies were performed and results collected before this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the device is a physical product (surgical gown) and the "ground truth" for its performance is established through objective, standardized laboratory testing (e.g., measuring forces, penetration, chemical residues) against predefined thresholds, not through expert human interpretation or consensus of observational data.

4. Adjudication method for the test set

This is not applicable for the same reasons as above. Performance is determined by meeting objective criteria in standardized tests, not by human adjudication of qualitative or ambiguous data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a surgical gown, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical product and does not involve any algorithms or AI for its function or evaluation.

7. The type of ground truth used

The ground truth for the performance of the surgical gown is established by objective measurements and adherence to predefined thresholds specified in international and national standards (e.g., ANSI/AAMI PB70:2012, ASTM D5034, AATCC 127, ISO 10993, etc.). These standards define what constitutes a "pass" or "fail" for various performance characteristics like liquid barrier, flammability, tensile strength, tear strength, seam strength, viral penetration, and biocompatibility.

8. The sample size for the training set

This is not applicable. The device is a physical medical device and does not involve any machine learning algorithms that require a "training set."

9. How the ground truth for the training set was established

This is not applicable as there is no training set for this type of device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
Prescription Use (Part 21 CFR 801 Subpart D)	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: +1.508.654.1988 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 4Disposable 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

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V. INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE

Device	Subject DeviceStringKingDisposableIsolation Gown(K221559)	Predicate: B.J.ZH.F.Panther MedicalEquipment Co., Ltd.(K202706)	Justification forDifferences
Manufacturer	StringKing	B.J.ZH.F. Panther MedicalEquipment	N/A
510K Number	K221559	K202706	N/A
ProductCommon Name	Disposable SurgicalGown	Surgical Gown	Same
Product Code	FYA	FYA	Same
Classification	Class II (21 CFR878.4040)	Class II (21 CFR878.4040)	Same
Intended Use /Indications forUse	The StringKingDisposable SurgicalGown is a sterile, singleuse surgical apparelintended to be worn byhealthcareprofessionals to helpprotect both the patientand the healthcareworker from the transferof microorganisms,body fluids andparticulate matter. TheStringKing SurgicalGowns meet Level 3and Level 4requirements ofANSI/AAMI PB 70:2012Liquid barrierperformance andclassification ofprotective apparel anddrapes intended for use	Surgical gowns are intended tobe worn by operating roompersonnel during surgicalprocedure to protect both thesurgical patient and theoperating room personnel fromtransfer of microorganisms,body fluids, and particulatematerial.Per ANSI/AAMI PB70:2012Liquid barrier performance andclassification of protectiveapparel and drapes intended foruse in health care facilities, thesurgical gowns met therequirements for Level 3classification.	Intended Use is the Same.Subject Device also meetsLevel 4 requirements
	in health care facilities.
Gown Sizes	Small, Medium,Large, X-Large, 2X-Large	Small, Medium, Large, X-Large, XX-Large and XXX-Large.	Similar; Predicateoffers XXX-Large
MaterialComposition	SMS ReinforcedSMS/PE - gownmaterial and ties	SMS polypropylenenonwoven + Polyester	Similar;
Design Features	Neck Closure: Hook& Loop TabBelt: TiesCuffs: KnitTransfer Tab	Neck Closure: not included in510k Summary.Belt: not listed in 510kSummaryCuffs: Knit	Similar
Color	Blue	Blue	Same
OTC Use	Yes	Yes	Same
Sterility	Sterile (EO)	Sterile (EO) and Bulk, non-sterile	Similar; predicatesavailable bulk, non-sterile
Use	Single Use,Disposable	Single Use, Disposable	Same
ANSI/AAMI PB70	Level 3 and Level 4	Level 3	Same ; Subject Devicealso meets Level 4requirements
Liquid BarrierPerformanceClassificationProperties	Device was tested inaccordance withAAMI PB70:2012and meets Level 4and Level 3requirements fora surgical gown.	Per ANSI/AAMI PB70:2012 Liquidbarrier performance andclassification of protective appareland drapes intended for use inhealth care facilities, the proposeddevices meet the requirements forLevel 3classification.	Same
Flammability	Meets requirementsof Class 1 per 16CFR 1610	Class 1 per 16 CFR 1610	Same
Non-barrierproperties		Not specified in 510k summary	Same
Tensile Strength;ASTM D5034 (MachineDirection)	Meets requirementsof ASTM D5034:$\ge$ 7lbf
Tensile Strength;ASTM D5034 (Crossdirection)	Meets requirementsof ASTM D5034:$\ge$ 7lbf
Trap Tear; ASTMD5587 (MachineDirection)	Meets requirementsof ASTM D5587:$\ge$ 2.3lbf
Trap Tear; ASTMD5587 (CrossDirection)	Meets requirementsof ASTM D5587:$\ge$ 2.3lbf
Seam Strength;ASTM D1683	Meets requirementsof ASTM D1683:$\ge$ 7lbf
Biocompatibility	Meets requirementsof ISO 10993-5, ISO10993-10, ISO10993-23 (non-cytotoxic, non-irritant, non-sensitizer)	Meets requirements of ISO10993-5, ISO 10993-10(non-cytotoxic, non-irritant, non-sensitizer)	Same
Ethylene oxideresiduals	Meets requirementsof ISO 10993-7	Meets requirements ofISO 10993-7	Same
Test Standard	AcceptanceCriteria	Results -ProposedDevice -StringKingDisposableSurgical Gown(K221559)	Pass/Fail
ANSI/AAMI PB70:2012		Meets ANSI/AAMIPB 70:2012 Level 3and Level 4 LiquidBarrier requirements
Water ResistanceHydrostatic PressureTest - AATCC 127:2017(cm)	$\ge$ 50cm	All samples passedat $\ge$ 50 cm	Pass
Flammability ofClothing Textiles - 16CFR Part 1610 (a)	Class 1: $\ge$ 3.5 seconds	All samples passed at$\ge$ 3.5 seconds	Pass
DurabilityASTM D-5034	$\ge$ 7lbf	All samples passed atgreater than 7lbf	Pass
Tensile StrengthASTM D-5034Machine Directionand CrossDirection	$\ge$ 7lbf	All samples passed atgreater than 7lbf	Pass
Trap Tear ASTM D5587-15Machine Direction andCross Direction	≥2.3lbf	All samples passedat≥2.3lbf	Pass
Water ResistanceImpact PenetrationTest AATCC 42	≤1.0g	All samples passed at≤1.0g	Pass
ASTM D1683Seam Strength	≥7lbf	All samples passed at≥7lbf	Pass
ASTM F1671Viral Penetration	Level 4: Blood andviralpenetrationresistanceNopenetration at 2psi	All samples showedno penetration at 2psi	Pass
Ethylene oxide residualsISO 10993-7	EO <4mg*ECH <9mg	EO residuals were notdetected ("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 TestingEndpoints	Acceptance Criteria	Results	Pass/Fail
Cytotoxicity – ISO 10993-5	≤Grade 2 (mild)	Grade 0	Pass

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Skin Sensitization- ISO 10993-10	Primary Irritation Index0-0.4 — Negligible0.5-1.9-Slight2-4.9-Moderate 5-8-Severe	0.0	Pass
Skin Irritation - ISO 10993-23	≤1 on Magnusson andKligman 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.

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.