(443 days)
Not Found
No
The device is a surgical gown, and the description focuses on material properties, barrier performance, and physical characteristics. There is no mention of software, data processing, or any technology that would involve AI or ML.
No
The device is a surgical gown intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to provide therapy.
No
The device is a surgical gown, intended to protect from transfer of microorganisms and body fluids. It is a protective apparel, not a device used for diagnosis.
No
The device described is a physical surgical gown made of nonwoven polypropylene, not software. The description details material properties, physical tests, and intended use as protective apparel.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gown is for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical characteristics of the gown (material, size, sterilization, barrier performance) and its classification as a Class II medical device under a product code for general and plastic surgery apparel. It does not mention any components or functions related to testing samples from the human body.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical properties and barrier performance of the gown (flammability, strength, water resistance, etc.), not on diagnostic accuracy or analytical performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This surgical gown does not perform such a function.
N/A
Intended Use / Indications for Use
The Sterile Level 3 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 ANSVAAMI 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.
Product codes
FYA
Device Description
The Sterile Level 3 Surgical Gown is a Class II medical device under the FDA product code of FYA, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Sterile Level 3 Surgical Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015.
The Sterile Level 3 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. The proposed devices are single use and EtO sterilized. The Sterile Level 3 Surgical Gowns are available in six sizes, including S, M, L, XXL and XXXL. The belt ties are integrated into the body. 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. The Sterile Level 3 Surgical Gown is provided as blue color. The Sterile Level 3 Surgical Gown is made of 50 Gsm PP (SMMS nonwoven polypropylene).
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 / surgical procedure
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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed subject device complies with the following standards:
Test Method: 16 CFR 1610, Purpose: Flammability of Textiles, Acceptance Criteria: Class 1, Result: Class 1
Test Method: ASTM D5034-09(2017), Purpose: Tensile Strength, Acceptance Criteria: ≥7 lbf, Result: Warp:20,59 lbf, Weft: 30,48 lbf
Test Method: ASTM D1683/D1683M-17(2018), Purpose: Seam Strength (Garment), Acceptance Criteria: ≥7 lbf, Result: RIGHT ARMHOLE SEAM STRENGTH / SLIPPAGE: 8.1 lbf
Test Method: ASTM D1683/D1683M-17(2018), Purpose: Seam Strength (Garment), Acceptance Criteria: ≥7 lbf, Result: LEFT ARMHOLE SEAM STRENGTH / SLIPPAGE: 9.8 lbf
Test Method: ASTM D1683/D1683M-17(2018), Purpose: Seam Strength (Garment), Acceptance Criteria: ≥7 lbf, Result: RIGHT SHOULDER SEAM STRENGTH / SLIPPAGE: 14.1 lbf
Test Method: ASTM D1683/D1683M-17(2018), Purpose: Seam Strength (Garment), Acceptance Criteria: ≥7 lbf, Result: LEFT SHOULDER SEAM STRENGTH / SLIPPAGE: 14.7 lbf
Test Method: ASTM D1683/D1683M-17(2018), Purpose: Seam Strength (Garment), Acceptance Criteria: ≥7 lbf, Result: RIGHT SLEEVE SEAM STRENGTH / SLIPPAGE: 9.0 lbf
Test Method: ASTM D1683/D1683M-17(2018), Purpose: Seam Strength (Garment), Acceptance Criteria: ≥7 lbf, Result: LEFT SLEEVE SEAM STRENGTH / SLIPPAGE: 9.1 lbf
Test Method: ASTM D5587-15 (2019), Purpose: Tear Strength, Acceptance Criteria: ≥ 2.3 lbf, Result: Warp:5,817 lbf, Weft: 8,958 lbf
Test Method: ISO 9073-10, Purpose: EVALUATION OF PARTICLES RELEASE, Acceptance Criteria: log 10 ≤4, Result: It is suitable according to ≤ 4 criteria.
Test Method: AATCC 127:2017 Option 2, Purpose: Water Resistance:Impact Penetration Test, Acceptance Criteria: ≥ 50 cm, Result: 53,7 - 65,8 cm. LEVEL 3.
Test Method: AATCC 42:2007, Purpose: Impact Penetration Test, Acceptance Criteria: no more than 1.0 grams (g), Result: Max 0.08. LEVEL 3
Test Method: ISO 10993-7:, Purpose: EO Residue Test, Acceptance Criteria: 10µg/cm², Result: Not detected.
Test Method: ISO 10993-5, Purpose: Cytotoxicity, Acceptance Criteria: Not Cytotoxic, Result: Not Cytotoxic
Test Method: ISO 10993-10, Purpose: Sensitization, Acceptance Criteria: Not Sensitive, Result: Not Sensitive
Test Method: ISO 10993-10, Purpose: Irritation, Acceptance Criteria: Not Irritant, Result: Not Irritant
Test Method: ASTM F88/F88M, Purpose: Seal Strength of Flexible Barrier Materials, Acceptance Criteria: Package Seal integrity must be intact., Result: Passed
Test Method: ASTM F1929:2015, Purpose: Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration, Acceptance Criteria: No leakage observe, Result: Passed
Test Method: ASTM D3776 / D3776M - 20, Purpose: Mass Per Unit Area (Weight) of Fabric, Acceptance Criteria: -, Result: 50 GSM
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the full name written in a sans-serif font. The full name is "U.S. FOOD & DRUG ADMINISTRATION".
July 22, 2022
Barco Tekstil Sanayi ve Ticaret A.S. % Mehmet Örmeci Consultant MEDCER Uluslararasi Medikal Belgelendirme A.S. Taspinar Mah. 2800 Cad. A-2 Apt. No:6 B/49 Ankara, Golbasi 06830 Turkey
Re: K211399
Trade/Device Name: Sterile Level 3 Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: June 21, 2022 Received: June 21, 2022
Dear Mehmet Örmeci:
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 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211399
Device Name Sterile Level 3 Surgical Gown
Indications for Use (Describe)
The Sterile Level 3 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 ANSVAAMI 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.
| 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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Image /page/3/Picture/0 description: The image shows the logo for BARCO. The logo is white text on a gray background. The A in BARCO is replaced with a yellow triangle. Below the word BARCO is the text "SOLUTIONS FOR TECHNICAL SPORTS WEAR".
510(k) Summary K211399
510(k) Summary
| 510(k) Submitter | BARCO TEKSTIL SANAYI VE TICARET A.S. | |
|---|---|---|
| 510(k) Submitter | Muratbey Mahallesi Karatoprak Caddesi No. 17 | |
| Catalca Istanbul, TR 34540 | ||
| 510(k) Submitter Telephone No | Phone: +90 212 867 49 00 | |
| Fax: +90 212 494 32 34 | ||
| Primary Correspondent | ||
| Contact Information | Mehmet Fatih Ormeci (Consultant) | |
| +90-532-397-3043 | ||
| mformeci@gmail.com | ||
| Fax: +90 212 494 32 34 | ||
| Summary Preparation Date | 07/21/2022 |
| Trade Or Proprietary
| Name | Sterile Level 3 Surgical Gown |
|---|---|
| Common Name | Surgical Gown |
| Classification Name | Gown, Surgical |
| Regulation Number | 21 CFR 878.4040 |
| Product Code | FYA |
| Subject Device
Name | Subject Device
510k No | Predicate Device
510k No | Predicate Device Manufacturer |
|----------------------------------|---------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterile Level 3
Surgical Gown | K211399 | K202706 | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD.
Floor 3, Building 1, 28 Huoju Street, Changping
Science and Technology Park, Changping District,
102200 Beijing, China |
Device Description
Sterile Level 3 Surgical Gown
The Sterile Level 3 Surgical Gown is a Class II medical device under the FDA product code of FYA, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Sterile Level 3 Surgical Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015.
The Sterile Level 3 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. The proposed devices are single use and EtO sterilized. The Sterile Level 3 Surgical Gowns are available in six sizes, including S, M, L, XXL and XXXL. The belt ties are integrated into the body. Per ANSI/AAMI PB70:2012 Liquid barrier
4
Image /page/4/Picture/0 description: The image shows the logo for BARCO, a company that provides solutions for technical sportswear. The logo is displayed in white text on a gray background. The "A" in BARCO is replaced with a yellow triangle.
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. The Sterile Level 3 Surgical Gown is provided as blue color. The Sterile Level 3 Surgical Gown is made of 50 Gsm PP (SMMS nonwoven polypropylene).
| Model Name | Size | Reference No | Colour | Level | Fabric | Sterilization | FDA
Code |
|----------------------------------|------|------------------------|--------|-------|---------------------------------------|---------------|-------------|
| Sterile Level 3
Surgical Gown | S | GS101-L3U-
50S-S | Blue | 3 | 50 Gsm PP
(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3
Surgical Gown | M | GS101-L3U-
50S-M | Blue | 3 | 50 Gsm PP
(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3
Surgical Gown | L | GS101-L3U-
50S-L | Blue | 3 | 50 Gsm PP
(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3
Surgical Gown | XL | GS101-L3U-
50S-XL | Blue | 3 | 50 Gsm PP
(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3
Surgical Gown | XXL | GS101-L3U-
50S-XXL | Blue | 3 | 50 Gsm PP
(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3
Surgical Gown | XXXL | GS101-L3U-
50S-XXXL | Blue | 3 | 50 Gsm PP
(Nonwoven Polypropylene) | Sterile | FYA |
Indications For Use
Sterile Level 3 Surgical Gown
The Sterile Level 3 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 surgical gowns met the requirements for Level 3 classification.
Technological Characteristics
Shown below is the technological characteristics comparison of the subject device and the predicate device.
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Image /page/5/Picture/0 description: The image shows the logo for BARCO, a company that provides solutions for technical sportswear. The logo is set against a gray background. The word "BARCO" is written in large, white letters, with a yellow triangle taking the place of the letter "A". Below the company name, the text "SOLUTIONS FOR TECHNICAL SPORTS WEAR" is written in a smaller font.
510(k) Summary
Surgical Gown
| Item | Subject Device
Sterile Level 3 Surgical Gown K211399 | Predicate Device K202706 | Remark |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Product Code | FYA | FYA | Same |
| Regulation No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Intended
Use/Indications for
Use | The Sterile Level 3 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 surgical gowns met the
requirements for 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 met the requirements for Level 3
classification. | Same |
| Style | Non-reinforced | Non-reinforced | Same |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Weight per square (g) | 50 Gsm | 55g/m2 | Different
1.1. |
| Size | S, M, L, XL, XXL, XXXL | S, M, L, XL, XXL, XXXL | Same |
| Flammability | Class I | Class I | Same |
| Hydrostatic pressure | >50 cm | >50 cm | Same |
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Breaking strength | >20N | >20N | Same |
| Tearing strength | >20N | >20N | Same |
| Linting | Log10