(268 days)
No reference devices were used in this submission.
No
The device is a disposable surgical gown, and the description focuses on material properties and barrier performance, with no mention of AI or ML.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is a surgical gown, which is protective apparel worn by healthcare professionals to prevent the transfer of microorganisms and fluids, not to provide therapy.
No
Explanation: The device is a surgical gown intended for protection, not for diagnosing any medical condition.
No
The device description clearly states it is a surgical gown made of physical materials (nonwoven spunbond-meltblownspunbond (SMS) polyolefin & Film Lamination). The performance studies also focus on physical properties and barrier performance, not software validation.
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 gown is for "protect[ing] both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical construction and materials of the gown, designed for protection and ease of use in a healthcare setting.
- No Mention of Diagnostic Testing: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies listed are related to the physical properties and barrier performance of the gown (liquid resistance, flammability, strength, viral penetration, sterilization), not diagnostic accuracy or performance.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This surgical gown does not perform any such function.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
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.
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
healthcare professionals
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)
The following performance data were provided in support of the substantial equivalence determination:
-
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:
- Cytotoxicity – ISO 10993-5: Results Grade 0; Pass (Acceptance Criteria ≤Grade 2 (mild)).
- Skin Sensitization – ISO 10993-10: Results 0.0; Pass (Acceptance Criteria Primary Irritation Index 0-0.4 — Negligible).
- Skin Irritation – ISO 10993-23: Results 0.0; Pass (Acceptance Criteria ≤1 on Magnusson and Kligman Scale).
-
Other Testing (from Comparison Table):
- ANSI/AAMI PB70:2012: Meets Level 3 and Level 4 Liquid Barrier requirements.
- Water Resistance Hydrostatic Pressure Test - AATCC 127:2017 (cm): All samples passed at ≥ 50 cm (Acceptance Criteria ≥ 50 cm).
- Flammability of Clothing Textiles - 16 CFR Part 1610 (a): All samples passed at ≥ 3.5 seconds (Acceptance Criteria Class 1: ≥ 3.5 seconds).
- Durability ASTM D-5034: All samples passed at greater than 7lbf (Acceptance Criteria ≥ 7lbf).
- Tensile Strength ASTM D-5034 Machine Direction and Cross Direction: All samples passed at greater than 7lbf (Acceptance Criteria ≥ 7lbf).
- Trap Tear ASTM D5587-15 Machine Direction and Cross Direction: All samples passed at ≥2.3lbf (Acceptance Criteria ≥2.3lbf).
- Water Resistance Impact Penetration Test AATCC 42: All samples passed at ≤1.0g (Acceptance Criteria ≤1.0g).
- ASTM D1683 Seam Strength: All samples passed at ≥7lbf (Acceptance Criteria ≥7lbf).
- ASTM F1671 Viral Penetration: All samples showed no penetration at 2psi (Acceptance Criteria Level 4: Blood and viral penetration resistance No penetration at 2psi).
- Ethylene oxide residuals ISO 10993-7: EO residuals were not detected ("ND") (Acceptance Criteria EO
§ 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.
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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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
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.
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
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
2
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 4 |
| 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.
4
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
StringKing
Disposable
Isolation Gown
(K221559) | Predicate: B.J.ZH.F.
Panther Medical
Equipment Co., Ltd.
(K202706) | Justification for
Differences |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Manufacturer | StringKing | B.J.ZH.F. Panther Medical
Equipment | N/A |
| 510K Number | K221559 | K202706 | N/A |
| Product
Common Name | Disposable Surgical
Gown | Surgical Gown | Same |
| Product Code | FYA | FYA | Same |
| Classification | Class II (21 CFR
878.4040) | Class II (21 CFR
878.4040) | Same |
| Intended Use /
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 | 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. | Intended Use is the Same.
Subject Device also meets
Level 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; Predicate
offers XXX-Large |
| Material
Composition | SMS Reinforced
SMS/PE - gown
material and ties | SMS polypropylene
nonwoven + Polyester | Similar; |
| Design Features | Neck Closure: Hook
& Loop Tab
Belt: Ties
Cuffs: Knit
Transfer Tab | Neck Closure: not included in
510k Summary.
Belt: not listed in 510k
Summary
Cuffs: Knit | Similar |
| Color | Blue | Blue | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Sterile (EO) | Sterile (EO) and Bulk, non-
sterile | Similar; predicates
available bulk, non-
sterile |
| Use | Single Use,
Disposable | Single Use, Disposable | Same |
| ANSI/AAMI PB70 | Level 3 and Level 4 | Level 3 | Same ; Subject Device
also meets Level 4
requirements |
| Liquid Barrier
Performance
Classification
Properties | Device was tested in
accordance with
AAMI PB70:2012
and meets Level 4
and Level 3
requirements 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, the proposed
devices meet the requirements for
Level 3
classification. | Same |
| Flammability | Meets requirements
of Class 1 per 16
CFR 1610 | Class 1 per 16 CFR 1610 | Same |
| Non-barrier
properties | | Not specified in 510k summary | Same |
| Tensile Strength;
ASTM D5034 (Machine
Direction) | Meets requirements
of ASTM D5034:
$\ge$ 7lbf | | |
| Tensile Strength;
ASTM D5034 (Cross
direction) | Meets requirements
of ASTM D5034:
$\ge$ 7lbf | | |
| Trap Tear; ASTM
D5587 (Machine
Direction) | Meets requirements
of ASTM D5587:
$\ge$ 2.3lbf | | |
| Trap Tear; ASTM
D5587 (Cross
Direction) | Meets requirements
of ASTM D5587:
$\ge$ 2.3lbf | | |
| Seam Strength;
ASTM D1683 | Meets requirements
of ASTM D1683:
$\ge$ 7lbf | | |
| Biocompatibility | Meets requirements
of ISO 10993-5, ISO
10993-10, ISO
10993-23 (non-
cytotoxic, non-
irritant, non-
sensitizer) | Meets requirements of ISO
10993-5, ISO 10993-10
(non-cytotoxic, non-irritant, non-
sensitizer) | Same |
| Ethylene oxide
residuals | Meets requirements
of ISO 10993-7 | Meets requirements of
ISO 10993-7 | Same |
| Test Standard | Acceptance
Criteria | Results -
Proposed
Device -
StringKing
Disposable
Surgical Gown
(K221559) | Pass/Fail |
| ANSI/AAMI PB70:2012 | | Meets ANSI/AAMI
PB 70:2012 Level 3
and Level 4 Liquid
Barrier requirements | |
| 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 | $\ge$ 7lbf | All samples passed at
greater than 7lbf | Pass |
| Tensile Strength
ASTM D-5034
Machine Direction
and Cross
Direction | $\ge$ 7lbf | All samples passed at
greater than 7lbf | Pass |
| Trap Tear ASTM D5587-
15
Machine Direction and
Cross Direction | ≥2.3lbf | All samples passed
at
≥2.3lbf | Pass |
| Water Resistance
Impact Penetration
Test AATCC 42 | ≤1.0
g | All samples passed at
≤1.0g | Pass |
| ASTM D1683
Seam Strength | ≥7lbf | All samples passed at
≥7lbf | Pass |
| ASTM F1671
Viral Penetration | Level 4: Blood and
viral
penetration
resistance
No
penetration at 2psi | All samples showed
no penetration at 2psi | Pass |
| Ethylene oxide residuals
ISO 10993-7 | EO