(97 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical barrier properties and material characteristics of a disposable isolation gown, with no mention of AI or ML.
No.
This device is an isolation gown intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
The device description and intended use clearly state that it is an isolation gown designed to protect against the transfer of microorganisms and fluids, not to diagnose any medical condition.
No
The device description clearly states it is a disposable, single-use isolation gown made of blue polyethylene, which is a physical material, not software. The performance studies also focus on physical properties and barrier performance.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a disposable isolation gown made of polyethylene. This is a physical barrier, not a reagent, instrument, or system intended for the examination of specimens.
- No mention of diagnostic procedures: The text does not describe any process involving the analysis of biological samples (blood, urine, tissue, etc.) to diagnose a condition or provide information about a physiological state.
- Performance Studies: The performance studies focus on barrier properties (water resistance, tear strength, flammability) and biocompatibility, which are relevant to a protective garment, not a diagnostic device.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This isolation gown does not fit that description.
N/A
Intended Use / Indications for Use
The StringKing Disposable Isolation Gown is intended to protect health care personnel and health care patients from the transfer of microorganisms, body fluids and particulate material. These gowns are not intended for use in the operating room. The StringKing Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The String King Disposable Isolation Gown is a single use, disposable medical device and is provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FYC
Device Description
Disposable, single-use isolation gown. The StringKing Disposable Isolation Gown is made of blue polyethylene and serves as a barrier to the transfer of microorganisms, body fluids and particulate material. The gowns feature hook and loop neck closure with a strap for fastening the back of the gown. The gown sleeves have thumb-loops to keep sleeves from sliding when donning the gown. The gowns are available in Large sizes. The gowns are non-sterile, single-use devices.
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
health care personnel and health care patients
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:
- ANSI/AAMI PB70:2012 (Level 3 for both subject and predicate device, Result: Same)
- Water Resistance HydrostaticPressure Test - AATCC 127:2017 (Both the subject and predicate device passed at ≥ 50cm)
- Water Resistance Impact Penetration Test AATCC 42 (Both the subject and predicate device passed at ≤ 1.0g)
- Flammability of Clothing Textiles - 16 CFR Part 1610 (a) (Both the subject and predicate device passed with an average of ≥ 3.5 seconds.)
- Tear Resistance - ASTM D1004 (Subject device not tested as this method is not required by ANSI/AAMI PB70:2012 or ASTM F2407-20)
- General Tensile Testing - ASTMD882 (Subject device not tested as this method is not required by ANSI/AAMI PB70:2012 or ASTM F2407-20)
- Trap Tear ASTM D5587-15 (Both the subject and predicate device passed at ≥2.3lbf)
- Grab Tensile CD ASTM D5034 (Both the subject and predicate device passed at ≥7lbf)
- ASTM D1683 Seam Strength (The subject device passed at ≥7lbf; test data not provided in 510k summary for predicate device)
- Liquid Barrier Performance Classification Properties (Both device was tested in accordance with AAMI PB70:2012 and meets Level 3 requirements for a surgical gown, Result: Same)
Biocompatibility Testing:
- Cytotoxicity: ISO 10993-5:2009 (Passed for both, Result: Same)
- Skin Irritation: ISO 10993-10:2010(R)2014 (Passed for both, Result: Same)
- Skin Sensitization: ISO 10993-10:2010(R)2014 (Passed for both, Result: Same)
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.
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.
No reference devices were used in this submission.
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
§ 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.
0
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 24, 2021
String King Lacrosse, LLC % Sharon Morrow Regulatory Affairs Consultant Medical Device Academy Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738
Re: K212633
Trade/Device Name: Disposable Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: August 3, 2021 Received: August 19, 2021
Dear Sharon Morrow:
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.
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
1
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,
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) K212633
Device Name Disposable Isolation Gown
Indications for Use (Describe)
The StringKing Disposable Isolation Gown is intended to protect health care personnel and health care patients from the transfer of microorganisms, body fluids and particulate material. These gowns are not intended for use in the operating room. The StringKing Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The String King Disposable Isolation Gown is a single use, disposable medical device and is provided non-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)
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3
K212633
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
l. SUBMITTER
String Kina Lacrosse, LLC 19100 S Vermont Ave. Gardena, CA, 90248 USA Tel: +1.508.654.1988 Fax: N/A
Contact Person: Thomas Frasca Date Prepared: November 23, 2021
DEVICE 11.
| Name of Device: | Disposable Isolation Gown |
|---|---|
| Classification Name: | Surgical Isolation Gown |
| Regulation: | 21 CFR § 878.4040 |
| Regulatory Class: | Class II |
| Product Classification Code: | FYC |
= PREDICATE DEVICE
| Predicate Manufacturer: | Wildcat PPE, LLC |
|---|---|
| Predicate Trade Name: | Wildcat PE Surgical Isolation Gown Full Back |
| Predicate 510(k): | K202310 |
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
Disposable, single-use isolation gown. The StringKing Disposable Isolation Gown is made of blue polyethylene and serves as a barrier to the transfer of microorganisms, body fluids and particulate material. The gowns feature hook and loop neck closure with a strap for fastening the back of the gown. The gown sleeves have thumb-loops to keep sleeves from sliding when donning the gown. The gowns are available in Large sizes. The gowns are non-sterile, single-use devices.
V. INDICATIONS FOR USE
The StringKing Disposable Isolation Gown is intended to protect health care personnel and health care patients from the transfer of microorganisms, body fluids and particulate material. These gownsare not intended for use in the operating room. The StringKing Disposable Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The String King Disposable Isolation Gown is a single use, disposable medical device and is provided nonsterile.
4
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE
The following characteristics were compared between the subject device and the predicate device to demonstrate substantial equivalence in Table 1 below.
| Device | Proposed Device -
Disposable Isolation
Gown | Predicate Device -
Wildcat PE Surgical
Isolation Gown Full
Back | Result |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Manufacturer | StringKing | Wildcat PPE, LLC | N/A |
| 510K Number | K212633 | K202310 | N/A |
| Product Common
Name | Disposable Isolation Gown | Surgical Isolation Gown | N/A |
| Product Code | FYC | FYC | Same |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same |
| Intended
Use/Indications for
Use | The StringKing Disposable
Isolation Gown is intended to
protect health care personnel and
health care patients from the
transfer of microorganisms, body
fluids and particulate material.
These gownsare not intended for
use in the operating room. The
StringKing Disposable Isolation
Gown meets the requirements of
an AAMI Level 3 barrier protection
for an isolation gown per
ANSI/AAMI PB70:2012 Liquid
Barrier Performance Classification
of Protective Apparel Drapes
Intended for Use in Health Care
Facilities (ANSI/AAMI PB70). The
String King Disposable Isolation
Gown is a single use, disposable
medical device and is provided
non-sterile. | Wildcat PE Surgical Isolation Gown
Full Back is intended to protect
health care patients and health care
personnel from the transfer of
microorganisms, body fluids and
particulate material. Not intended for
use in the operating room. In
addition, The Wildcat PE Surgical
Isolation Gown Full Back meets the
requirements of an AAMI Level 3
barrier protection for an isolation
gown per ANSI/AAMI PB70:2012
Liquid Barrier and Performance
Classification of Protective Apparel
and Surgical Drapes Intended for
Use in Health Care Facilities
(ANSI/AAMI PB70). The Wildcat PE
Surgical Isolation Gown Full Back is
a single use, disposable medical
device provided non-sterile. | Same |
| Material
Composition | Polyethylene LDPE
CAS # 9002-88-4 | Linear Low-Density Polyethylene
(LLDPE) | Same |
| Design Features | Hook and Loop Neck Closure
Closed back - tie at waist
Thumb Loops | Tabs Tie in the Middle of Back
Thumbhole at Cuff | Similar; predicate
device has ties at
neck while
subject device
has hook and
loop |
| Color | Blue
CAS # 147-14-8 | Blue (CAS unknown) | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
Table 1 – Comparison of Technological Characteristics
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VII. NON-CLINICAL PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
| Device | Proposed Device -
Disposable
Isolation Gown | Predicate Device -
Wildcat PE Surgical
Isolation Gown (K202310) | Result |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| ANSI/AAMI
PB70:2012 | Level 3 | Level 3 | Same |
| Water Resistance
HydrostaticPressure
Test - AATCC
127:2017 (cm) | Fabric (body)
Mean 170.33
Min 128.87
Max 196.87
Sleeve
Mean 126.60
Min 54.83
Max 189.40
Armhole
Each lot tested had less
than 4 failures in the
armhole region; thus
meeting the
requirement of AQL 4.0. | Chest:
Mean = $>151$
Min = 155
Max = $>155$
Sleeve Seam: Mean = $>165$
Min = 171
Max = $>173$ | Both the subject and predicate
device passed at $\ge$ 50cm |
| Water Resistance
Impact Penetration
Test AATCC 42 | Fabric (body)
Mean 0.01
Min 0.00
Max 0.11
Sleeve
Mean 0.03
Min 0.01
Max 0.38
Armhole
Mean 0.02
Min 0.00
Max 0.16 | Chest:
Mean = $ 3.5
seconds. Both the subject and
predicate device passed with
an average of $\ge$ 3.5 seconds. |
| Tear Resistance -
ASTM D1004* | N/A | Max Load (lbf): Mean = 1.04
Min = .95
Max = 1.17
Max Extension (in):
Mean = 1.01
Min = .91
Max = 1.10 | Subject device not tested as
this method is not required
by ANSI/AAMI PB70:2012
or ASTM F2407-20 |
| General Tensile
Testing - ASTMD882* | N/A | Breaking Factor (lbf/in):
Mean = 6.66
Min = 4.87
Max = 9.20
Tensile (Max) (MPa):
Mean = 24.8
Min = 19.7
Max = 33.4
Tensile (Break) (MPa):
Mean = 21.5
Min = 15.9
Max = 33.4
Elongation (%): Mean = 1061
Min = 945
Max = 1327
Modulus (MPa): Mean = 91.1
Min = 2.58
Max = 117 | Subject device not tested as
this method is not required
by ANSI/AAMI PB70:2012
or ASTM F2407-20 |
| Trap Tear ASTM
D5587-15 | Length
Mean 3.80
Min 3.18
Max 4.46
Width
Mean 6.88
Min 6.26
Max 7.58 | Mean = 5.10
Ind Min = 3.2
Ind Max = 7.0 | Both the subject and
predicate device passed at
≥2.3lbf |
| Grab Tensile CD
ASTM D5034 | Length
Mean 23.75
Min 20.54
Max 25.91
Width
Mean 19.63
Min 17.10
Max 21.59 | Mean = 21.95
Ind Min = 20.60
Ind Max = 23.30 | Both the subject and
predicate device passed at
≥7lbf |
| | | | |
| ASTM D1683
Seam Strength | Sleeve
Mean 11.95
Min 6.48
Max 18.18
Armhole
Mean 12.30
Min 6.95
Max 17.41 | Not included in 510k summary | The subject device passed at
≥7lbf; test data not provided
in 510k summary for
predicate device |
| Liquid Barrier
Performance
Classification
Properties | Device was tested in
accordance with
AAMI PB70:2012
and meets Level 3
requirements for a
surgical gown. | Device was tested in
accordance with AAMI
PB70:2012 and meets Level 3
requirements for a surgical
gown. | Same |
| Biocompatibility | | | |
| Cytotoxicity: ISO
10993-5:2009 [FR
Recognition #2-245]
Study # JN2010831 | Pass
Test Articles:
Grade 0 (non-cytotoxic) | Details not included in 510k
summary; Summary states "Pass:
ISO 10993-1" | Same |
| Skin Irritation: ISO
10993-
10:2010(R)2014 [FR
Recognition 2-174]
Study #: JN2010832 | Negligible (pass)
Specimen:0.0 non-irritating | Details not included in 510k
summary; Summary states "Pass:
ISO 10993-1" | Same |
| Skin Sensitization:
ISO 10993-
10:2010(R)2014 [FR
Recognition 2-174]
Study #: JN2010833 | No sensitization noted
(pass)
Specimen:0.0
non- sensitizing | Details not included in 510k
summary; Summary states "Pass:
ISO 10993-1" | Same |
| Sterilization Modality | None (Non-Sterile) | None (Non-Sterile) | Same |
6
7
*These tests are specifically for tear and tensile properties of thin plastic sheeting.
The following standards were utilized in performance and biocompatibility testing of the StringKing Disposable Isolation Gown.
Table 2 – Use of Standards
| | Standards
Organization | Standards Title |
|----------|---------------------------|---------------------------------------------------------------------------------------------|
| PB70 | AAMI | AAMI PB70 Liquid Barrier Performance Classification of Protective
Apparel |
| TM 127 | AATCO | Water Resistance: Hydrostatic Pressure Test |
| TM 42 | AATCO | Water Resistance: Impact Penetration Test |
| F2407-20 | ASTM | Standard Specification for Surgical Gowns Intended for Use
in Healthcare Facilities |
| D5034 | ASTM | Standard Test Method for Breaking Strength and Elongation
of Textile Fabrics (Grab Test) |
8
| D5587 | ASTM | Standard Test Method for Tearing Strength of Fabrics by
Trapezoid Procedure |
|-----------|------|--------------------------------------------------------------------------------------------------------------|
| D1683 | ASTM | Standard Test Method for Failure in Sewn Seams of Woven Fabrics |
| Part 1610 | CPSC | Standard for the Flammability of Clothing Textiles |
| 10993-1 | ISO | ISO 10993-1 Biological Evaluation of Medical Devices- Part 1:
Evaluation and |
| 10993-5 | ISO | Biological Evaluation of Medical Devices- Part 5: Tests for
In-Vitro Cytotoxicity |
| 10993-10 | ISO | Biological Evaluation of Medical Devices- Part 10: Tests for
irritation and delayed-type hypersensitivity |
Sterilization & Shelf-life Testing
Not Applicable (This is a non-sterile device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.)
Biocompatibility Testing
Biocompatibility testing was performed in accordance with ISO 10993-1:2018. Specifically, the following testing endpoints were evaluated.
Table 3 - Biocompatibility Testing
| Biocompatibility Testing Endpoints | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity - ISO 10993-5 | Non-Cytotoxic | Pass |
| Skin Sensitization - ISO 10993-10 | Non- Sensitizing | Pass |
| Skin Irritation - ISO 10993-10 | Non-Irritating | Pass |
Software Verification and Validation Testing
Not Applicable (Passive Device)
Electrical safety and electromagnetic compatibility (EMC)
Not Applicable (Passive Device)
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Human Clinical Performance Testing
Clinical testing was not required to demonstrate the safety and effectiveness of the device.
VIII. CONCLUSIONS
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K202310), manufactured by Wildcat PPE LLC.