(270 days)
No
The device is a surgical gown, and the description focuses on its physical properties and barrier performance, with no mention of AI or ML.
No
The device is a surgical gown, which is intended to protect against the transfer of microorganisms and fluids, not to provide therapeutic treatment.
No
This device is a surgical gown, which is a protective apparel used to prevent the transfer of microorganisms and fluids. It does not perform any diagnostic function.
No
The device description clearly states it is a surgical gown, which is a physical garment made of material, not software. The performance studies and key metrics also relate to the physical properties of the gown (flammability, water resistance, strength, biocompatibility).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gown is for protecting surgical patients and personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a protective barrier function, not a diagnostic function.
- Device Description: The description reinforces the protective barrier function and mentions its classification based on liquid barrier performance. There is no mention of analyzing samples from the human body or providing diagnostic information.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition.
- Performance Studies and Metrics: The performance studies and key metrics focus on physical properties like barrier performance, strength, flammability, and biocompatibility – all relevant to a protective garment, not a diagnostic device.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical gown does not perform any of these functions.
N/A
Intended Use / Indications for Use
GCI surgical gown is 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. 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 2 barrier classification.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
GCI Surgical Gowns are intended to be used during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate materials. The gown is available in multiple sizes. They are provided non- sterile and intended to be sterilized prior to use. They are reusable up to 75 uses.
Per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel intended for use in health care facilities, the proposed devices meet the requirements for 2, as indicated by their labeling.
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
operating room personnel / operating room
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gowns were assessed for performance using the following standards and test methods:
- Flammability (16 CFR §1610): Meets Class 1 Requirements.
- Water Resistance: Hydrostatic Pressure (AATCC 127:2017): Water Resistant ≥20 cm.
- Water Resistance: Impact Penetration (AATCC 42:2017): ≤1.0 g water.
- Breaking / Bursting Strength (ASTM D5034:2017): >20 N.
- Tearing Strength (ASTM D5587:2019): >20 N.
- Seam Strength (ASTM D1683/D1683M:2017/(R)2018): >20 N.
- Linting (ISO 9073-10:2003): Log10
§ 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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August 2, 2024
George Courey Inc % Sarah Fitzgerald Senior Consultant Emergo by UL 2500 Bee Cave Road Building 1. Suite 300 Austin, Texas 78746
Re: K233571
Trade/Device Name: GCI Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: November 3, 2023 Received: November 6, 2023
Dear Sarah Fitzgerald:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Allan Gua
For Bifeng Qian, M.D., Ph.D. Assistant Director
2
DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233571
Device Name GCI Surgical Gown
Indications for Use (Describe)
GCI surgical gown is 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. 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 2 barrier classification.
| 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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K233571 - 510(k) Summary GCI Surgical Gown
1. Submission Sponsor
George Courey, Inc. 6620, Ernest-Cormier Laval, Quebec, H7C 2T5 Canada Contact: Cort Naab Title: Director of Surgical Solutions Telephone: 850-382-9077 E-mail: cnaab@georgecourey.com
2. Submission Correspondent
Emergo by UL 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Sarah Marie Fitzgerald Title: Senior Consultant, Quality and Regulatory Affairs
3. Date Prepared
July 31, 2024
4. Device Identification
| Trade/Proprietary Name: | GCI Surgical Gown |
|---|---|
| Common/Usual Name: | Surgical Gowns |
| Classification Name: | Surgical Apparel |
| Regulation Number: | 878.4040 |
| Product Code: | FYA |
| Class: | 2 |
| Classification Panel: | General Hospital |
5. Legally Marketed Predicate and Reference Device(s)
| Predicate Device name: | Level 2 Standard Surgical Gown1 |
|---|---|
| 510(k) number: | K211422 |
| Manufacturer: | Jiangsu Medplus Non-woven Manufacturer Co., Ltd. |
| Common/Usual Name: | Surgical Gowns |
| Classification Name: | Surgical Apparel |
| Regulation Number: | 878.4040 |
| Product Code: | FYA |
| Class: | 2 |
Reference Device Name:
Innerbloc LR Surgical Gowns
¹ The predicate also includes Level 3 gowns, but only the Level 2 gowns are relevant for this submission. K233571
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| 510(k) number: | K092344 |
|---|---|
| Manufacturer: | Lac Mac, Limited |
| Common/Usual Name: | Surgical Gowns |
| Classification Name: | Surgical Apparel |
| Regulation Number: | 878.4040 |
| Product Code: | FYA |
| Class: | 2 |
6. Indication for Use Statement
GCI surgical gown is 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.
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 2 barrier classification.
7. Device Description
GCI Surgical Gowns are intended to be used during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate materials. The gown is available in multiple sizes. They are provided non- sterile and intended to be sterilized prior to use. They are reusable up to 75 uses.
Per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel intended for use in health care facilities, the proposed devices meet the requirements for 2, as indicated by their labeling.
8. Substantial Equivalence Discussion
The following table compares the subject device to the predicate devices with respect to intended use, indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence.
The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
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Table 1 – Comparison of Intended Use and Indications for Use: GCI Surgical Gown
| Attribute | SUBJECT: K233571 GCI Surgical Gown | PREDICATE: K211422 Level 2 Standard Surgical Gown | Comparison |
|---|---|---|---|
| Intended Use | To protect both patients and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. | To protect both patients and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. | Same |
| Indications for Use | GCI surgical gown is 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. | ||
| 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 2 barrier classification. | Surgical gown is 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 Level 2 standard surgical gowns met the requirements for Level 2 barrier classification, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification. | Similar | ||
| Subject Device does not have Level 3 Gown. | |||
| Meets barrier level requirements per PB70 |
Table 2 – Comparison of Characteristics: GCI Surgical Gowns
| Attribute | SUBJECT: K233571
GCI Surgical Gown | PREDICATE: K211422
Level 2 Standard Surgical Gown | REFERENCE: K092344
Innerbloc LR Surgical Gowns | Comparison |
|----------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FYA | FYA | FYA | Same |
| Regulation Number | 878.4040 | 878.4040 | 878.4040 | Same |
| Class | II | II | II | Same |
| Intended Use
Overview | To protect from the transfer of microorganisms, body fluids, and particulate material. | To protect from the transfer of microorganisms, body fluids, and particulate material. | To protect from the transfer of microorganisms, body fluids, and particulate material. | Same |
| Prescription or OTC | OTC | OTC | OTC | Same |
| Barrier Level | Level 2 | Level 2
(See Note below table) | Unknown
(See Note below table) | Same |
| Device Materials | Polyester and carbon | SMS nonwoven polyester and polyamide | Polyester and PTFE | Similar
No differences to safety or effectiveness, as confirmed by performance and |
| Attribute | SUBJECT: K233571
GCI Surgical Gown | PREDICATE: K211422
Level 2 Standard Surgical Gown | REFERENCE: K092344
Innerbloc LR Surgical Gowns | Comparison |
| Sizes | S, M, L, XL, XXL / 2XL, XXXL /
3XL, XXXXL / 4XL, XL Tall | XS, S, M, L, XL, XXL, XXXL | Multiple sizes | biocompatibility testing.
Different
Provides a range of sizes to fit a
wide range of users. No
differences to safety or
effectiveness, as confirmed by
performance testing. |
| Color | Blue | Blue | Blue | Same |
| Reinforcement | Non-reinforced | Non-reinforced
(See Note below table) | Non-reinforced | Same |
| Method of Action | Physical barrier | Physical barrier | Physical barrier | Same |
| Durability | Reusable | Single-Use (Disposable) | Reusable | Different
Same as reference device.
No differences to safety or
effectiveness, as confirmed by
performance testing. |
| Flammability | Class 1 | Class 1 | Unknown | Same |
| Water Resistance:
Hydrostatic
Pressure | Water Resistant ≥20 cm | Water Resistant ≥20 cm
(See Note below table) | Unknown | Same |
| Water Resistance:
Impact Penetration | ≤1.0 g water | ≤1.0 g water | Unknown | Same |
| Breaking / Bursting
Strength | >20 N | >20 N | Unknown | Same |
| Tearing Strength | >20 N | >20 N | Unknown | Same |
| Seam Strength | >20 N | Unknown | Unknown | Equivalent
Meets expectations per
standard for appropriate barrier
protection level. |
| Linting | Log10 ≤ 4 | Log10 ≤ 4 | Unknown | Same |
| Attribute | SUBJECT: K233571
GCI Surgical Gown | PREDICATE: K211422
Level 2 Standard Surgical Gown | REFERENCE: K092344
Innerbloc LR Surgical Gowns | Comparison |
| Sterility | Non-Sterile (for use Sterile,
SAL $10^{-6}$ ) | Sterile, SAL $10^{-6}$ | Unknown | Provided Different
Same for Use
No differences to safety or
effectiveness, as confirmed by
sterilization validation aligned
with the provided instructions. |
| - Cytotoxicity | Under the conditions of the
study, the device is non-
cytotoxic. | Under the conditions of the
study, the device is non-
cytotoxic. | Unknown | Same |
| - Irritation | Under the conditions of
study, not an irritant | Under the conditions of study,
not an irritant | Unknown | Same |
| - Sensitization | Under the conditions of
study, not a sensitizer. | Under the conditions of study,
not a sensitizer. | Unknown | Same |
7
George Courey Traditional 510(k) Premarket Submission GCI Surgical Gowns
GEMERGO
by UL
8
George Courey Traditional 510(k) Premarket Submission GCI Surgical Gowns
by UL
| Note: K211422 also includes additional gowns) and styles (including reinforced) but equivalence only claimed to these gowns.
9
9. Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gowns were assessed for performance using the following standards and test methods, as also described in Table 2, and in alignment with FDA guidance "Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings" and "Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes." All testing results passed pre-determined acceptance criteria.
| Attribute | Purpose: To ensure compliance with the
following standard | Acceptance
Criteria | Results |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------|
| Flammability | 16 CFR §1610: Standard for the Flammability of
Clothing Textile | Meets Class 1
Requirements | Meets Class 1
Requirements |
| Water Resistance:
Hydrostatic
Pressure | AATCC 127:2017 Water Resistance: Hydrostatic
Pressure Test | Water Resistant
≥20 cm | Water Resistant
≥20 cm |
| Water Resistance:
Impact Penetration | AATCC 42:2017 Water Resistance: Impact
Penetration Test | ≤1.0 g water | ≤1.0 g water |
| Breaking / Bursting
Strength | ASTM D5034:2017 Standard Test Method for
Breaking Strength and Elongation of Textile Fabrics
(Grab Test) | ≥20 N | >20 N |
| Tearing Strength | ASTM D5587:2019 Standard Test Method for
Tearing Strength of Fabrics by Trapezoid Procedure | ≥20 N | >20 N |
| Seam Strength | ASTM D1683/D1683M:2017/(R)2018 Standard
Test Method for Failure in Sewn Seams of Woven
Fabrics | ≥20 N | >20 N |
| Linting | ISO 9073-10:2003 Textiles – Test Methods for
Nonwovens - Part 10: Lint and Other Particles
Generation in the Dry State | Log10