(434 days)
No
The 510(k) summary describes a standard surgical gown made of nonwoven material, with no mention of AI or ML technology in its intended use, device description, or performance studies.
No.
The device description indicates that surgical gowns are intended for protection against transfer of microorganisms, body fluids, and particulate material, not for treating any specific medical condition or disease.
No
Explanation: The provided text describes surgical gowns, which are protective apparel used to prevent the transfer of microorganisms and fluids. There is no information to suggest that these gowns are used to diagnose any medical condition.
No
The device is a physical surgical gown made of nonwoven material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical gowns are for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical characteristics and materials of the gown, again emphasizing its protective barrier role.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis.
- Standards: The referenced standard (ASNI/AAMI PB70:2012) relates to liquid barrier performance of protective apparel, not diagnostic testing.
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
Surgical gowns 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. This device is provided sterile.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 classification.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
Surgical gowns are intended to be worn by healthcare professionals to protect both the patient and the healthcare professional from the transfer or microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and ethylene oxide (EO) sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL.
The proposed surgical gowns are constructed of a Spunbond (SMS) nonwoven material, with cuffs made of polyester and elastic, offered in standard (non-reinforced) and reinforced surgical gowns, in blue color.
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 / health care facilities
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 test results demonstrate that the proposed device complies with the following standards by passing all applicable acceptance criteria.
Test Method: AATCC 127
Purpose: Hydrostatic pressure
Acceptance Criteria: Level 2 > 20 cm Level 3 > 50 cm
Result: Pass
Test Method: AATCC 42
Purpose: Impact penetration
Acceptance Criteria: = 115N Width Direction >= 115N
Result: Pass
Test Method: ASTM D 5587
Purpose: Tearing strength by Trapezoid Procedure
Acceptance Criteria: Length Direction > 20 N Width Direction > 20 N
Result: Pass
Test Method: ASTM D 1683
Purpose: Seam strength
Acceptance Criteria: >= 20 N
Result: Pass
Test Method: 16 CFR Part 1610
Purpose: Flammability of Textiles
Acceptance Criteria: Class 1
Result: Class 1
Test Method: ISO 10993-7
Purpose: Ethylene oxide residues
Acceptance Criteria: EO residual
§ 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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February 16, 2023
Bayteks Teknik Tekstil San. ve Tic. A.S. % Sarah Fitzgerald Senior Consultant, Quality and Regulatory Affairs Emergo by UL 2500 Bee Cave Road, Building 1 Suite 300 Austin, Texas 78746
Re: K213844
Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: February 13, 2023 Received: February 15, 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 (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 medical devices and radiation-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, MD, 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) K213844
Device Name Surgical Gown
Indications for Use (Describe)
Surgical gowns are intended to be worn by operating room personnel procedure to protect both the surgical patient and the operating room persomel from transfer of microorganisms, body fluids, and particulate material. This device is provided sterile.
Per ASNI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 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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3
510(k) Summary
SURGICAL GOWN
K213844
The following information is provided in accordance with 21 CFR 807.92 for the premarket 510(k) summary:
1. Submission Sponsor
Bayteks Teknik Tekstil San. Ve Tic. A.S. Organize Sanaji Bolgesi 19. Nolu Cad. No. 9 Merkez, Kilis 79000 Turkey Contact: Spero Hegbe, Export Sales Specialist Telephone: 90 (530) 149 34 63 Fax: 90 (348) 834 10 28 sperohegbe@baymed.com.tr
2. Submission Correspondent
Emergo Global Consulting, LLC 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, Senior Consultant, Quality and Regulatory Affairs
3. Date Prepared
February 15, 2023
4. Device Identification
| Trade/Proprietary Name: | Surgical Gown |
|---|---|
| Common/Usual Name: | Surgical Gown |
| Regulation Number: | 21 CFR 878.4040 |
| Product Code: | FYA |
| Class: | II |
| Review Panel: | General Hospital |
5. Legally Marketed Predicate and Reference Devices
Predicate Device name: Surgical Gown 510(k) number: K202706
4
Manufacturer: B.J.ZH.F. Panther Medical Equipment Co., Ltd.
Reference Device name: Medline Surgical Gown 510(k) number: K190950 Manufacturer: Medline Industries, Inc.
6. Indication for Use Statement
Surgical gowns 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. This device is provided sterile.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 classification.
7. Device Description
Surgical gowns are intended to be worn by healthcare professionals to protect both the patient and the healthcare professional from the transfer or microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and ethylene oxide (EO) sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL.
The proposed surgical gowns are constructed of a Spunbond (SMS) nonwoven material, with cuffs made of polyester and elastic, offered in standard (non-reinforced) and reinforced surgical gowns, in blue color.
8. Comparison of technological characteristics with the Predicate
The following table compares the subject device to the predicate device with respect to indications for use, principles of operation, technological characteristics, 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.
| Attribute | Subject Gown
K213844 | Predicate Gown
K202706 | Reference Device
K190950 | Comparison |
|----------------------|------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------|------------|
| Product Code | FYA | FYA | FYA | Same |
| Regulation
Number | 878.4040 | 878.4040 | 878.4040 | Same |
| Class | II | II | II | Same |
| Intended Use | To protect both patients
and healthcare
personnel from the | To protect both patients
and healthcare personnel
from the transfer of | To protect both
patients and
healthcare personnel | Same |
| Table 1 – Comparison of Technological Characteristics | ||
|---|---|---|
| ------------------------------------------------------- | -- | -- |
5
| Attribute | Subject Gown
K213844 | Predicate Gown
K202706 | Reference Device
K190950 | Comparison |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | transfer of
microorganisms, body
fluids, and particulate
material. | microorganisms, body
fluids, and particulate
material. | from the transfer of
microorganisms,
body fluids, and
particulate material. | |
| Indication for
Use | Surgical gowns 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.
This device is provided
sterile. Per ANSI/AAMI
PB70:2012 Liquid
barrier performance
and classification of
protective apparel and
drapes intended for use
in health care facilities,
the standard (non-
reinforced) surgical
gowns meet Level 2
classification and the
reinforced surgical
gowns meet Level 3
classification. | 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 meet
the requirements for
Level 3 classification. | The [multiple named
gowns] are 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 [gowns] meet the
respective level
requirements of
ANSI/AAMI PB70:2012
Liquid barrier
performance and
classification of
protective apparel and
drapes intended for use
in healthcare facilities.
The [gowns] have been
validated using an
ethylene oxide (EtO)
sterilization process. The
[gowns] are also sold as
bulk single use, non-
sterile, to
repackager/relabeler
establishments for
further packaging and
sterilization using the
validated EtO
sterilization method
according to ISO 11135-1
prior to being provided
to the end user. | Similar |
| Prescription or
OTC | OTC | OTC | OTC | Same |
| Barrier Level
(per
ANSI/AAMI
PB70) | Standard: Level 2
Reinforced: Level 3 | Level 3 | Standard: Level 2
Reinforced: Level 3 | Similar |
| Attribute | Subject Gown
K213844 | Predicate Gown
K202706 | Reference Device
K190950 | Comparison |
| Device Materials | SMS Polypropylene
nonwoven, Polyester | SMS Polypropylene
nonwoven, Polyester | SMS Polypropylene
nonwoven, Polyester | Same |
| Device Design | Standard
(nonreinforced) &
Reinforced | Standard (nonreinforced) | Standard (nonreinforced)
& Reinforced | Similar |
| Durability | Single-Use (Disposable) | Single-Use (Disposable) | Single-Use (Disposable) | Same |
| Sizes | Small (S), Medium (M),
Large (L), Extra Large
(XL), Extra Extra Large
(XXL), Extra Extra Extra
Large (XXXL) | Small (S), Medium (M),
Large (L), Extra Large
(XL), Extra Extra Large
(XXL), Extra Extra Extra
Large (XXXL) | Small (S), Medium (M),
Large (L), Extra Large
(XL), Extra Extra Large
(XXL), Extra Extra Extra
Large (XXXL) | Same |
| Color | Blue | Blue | Blue | Same |
| Flammability
16 CFR Part 1610 | Class I | Class I | Class I | Same |
| Hydrostatic
Pressure
AATCC 127 | Level 2 > 20 cm
Level 3 > 50 cm | > 50 cm | - | Similar |
| Impact
Penetration
AATCC 42 | 20 N
Width Direction > 20 N | > 20 N | - | Same |
| Tensile
Strength
ASTM F 2407
(ASTM D 5034) | Length Direction ≥ 115N
Width Direction ≥ 115N | > 20 N | - | Same |
| Seam Strength
ASTM D1683 | ≥ 20 N | > 20 N | - | Same |
| Linting
ISO 9073-10 | Log10 20 cm
Level 3 > 50 cm | Pass |
| AATCC 42 | Impact penetration | ≤1g | Pass |
| ASTM F 2407
(ASTM D 5034) | Tensile Strength | Length Direction ≥ 115N
Width Direction ≥ 115N | Pass |
| ASTM D 5587 | Tearing strength by
Trapezoid Procedure | Length Direction > 20 N
Width Direction > 20 N | Pass |
| ASTM D 1683 | Seam strength | ≥ 20 N | Pass |
| 16 CFR Part 1610 | Flammability of Textiles | Class 1 | Class 1 |
| ISO 10993-7 | Ethylene oxide residues | EO residual ≤ 4 mg/device
ECH residual ≤ 9 mg/device | Pass |
| ISO 9073-10 | Linting | Log10