Sterile Level 3 Surgical Gown
Device Facts
| Record ID | K211399 |
|---|---|
| Device Name | Sterile Level 3 Surgical Gown |
| Applicant | Barco Tekstil Sanayi VE Ticaret A.S. |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Jul 22, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
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.
Device Story
Sterile Level 3 Surgical Gown; single-use protective apparel; worn by operating room personnel during surgical procedures. Device acts as physical barrier to prevent transfer of microorganisms, body fluids, and particulate material between patient and personnel. Constructed from 50 Gsm SMMS nonwoven polypropylene; EtO sterilized. Available in six sizes (S-XXXL) with integrated belt ties. Provides Level 3 liquid barrier performance per ANSI/AAMI PB70:2012. Used in clinical/surgical settings to enhance infection control and patient/staff safety.
Clinical Evidence
No clinical data. Bench testing only. Compliance verified via standards: 16 CFR 1610 (flammability), ASTM D5034 (tensile strength), ASTM D1683 (seam strength), ASTM D5587 (tear strength), ISO 9073-10 (particle release), AATCC 127/42 (water resistance/impact penetration), and ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, EO residue).
Technological Characteristics
Material: 50 Gsm SMMS nonwoven polypropylene. Barrier: Level 3 per ANSI/AAMI PB70:2012. Sterilization: EtO. Form factor: Disposable surgical gown, six sizes. Connectivity: None. Standards: ASTM D5034, ASTM D1683, ASTM D5587, AATCC 127, AATCC 42, ISO 10993.
Indications for Use
Indicated for operating room personnel during surgical procedures to provide a barrier against microorganisms, body fluids, and particulate material. No specific age or gender restrictions.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD. (K202706)
Submission Summary (Full Text)
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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.
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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
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# 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<br>Catalca Istanbul, TR 34540 | |
| 510(k) Submitter Telephone No | Phone: +90 212 867 49 00<br>Fax: +90 212 494 32 34 | |
| Primary Correspondent<br>Contact Information | Mehmet Fatih Ormeci (Consultant)<br>+90-532-397-3043<br>mformeci@gmail.com<br>Fax: +90 212 494 32 34 | |
| Summary Preparation Date | 07/21/2022 | |
| Trade Or Proprietary<br>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<br>Name | Subject Device<br>510k No | Predicate Device<br>510k No | Predicate Device Manufacturer |
|----------------------------------|---------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterile Level 3<br>Surgical Gown | K211399 | K202706 | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD.<br>Floor 3, Building 1, 28 Huoju Street, Changping<br>Science and Technology Park, Changping District,<br>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
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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<br>Code |
|----------------------------------|------|------------------------|--------|-------|---------------------------------------|---------------|-------------|
| Sterile Level 3<br>Surgical Gown | S | GS101-L3U-<br>50S-S | Blue | 3 | 50 Gsm PP<br>(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3<br>Surgical Gown | M | GS101-L3U-<br>50S-M | Blue | 3 | 50 Gsm PP<br>(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3<br>Surgical Gown | L | GS101-L3U-<br>50S-L | Blue | 3 | 50 Gsm PP<br>(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3<br>Surgical Gown | XL | GS101-L3U-<br>50S-XL | Blue | 3 | 50 Gsm PP<br>(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3<br>Surgical Gown | XXL | GS101-L3U-<br>50S-XXL | Blue | 3 | 50 Gsm PP<br>(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3<br>Surgical Gown | XXXL | GS101-L3U-<br>50S-XXXL | Blue | 3 | 50 Gsm PP<br>(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<br>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<br>Use/Indications for<br>Use | The Sterile Level 3 Surgical Gown is<br>intended to be worn by operating room<br>personnel during surgical procedure to<br>protect both the surgical patient and the<br>operating room personnel from transfer of<br>microorganisms, body fluids, and<br>particulate material. Per ANSI/AAMI<br>PB70:2012 Liquid barrier performance and<br>classification of protective apparel and<br>drapes intended for use in health care<br>facilities, the surgical gowns met the<br>requirements for Level 3 classification. | Surgical gowns are intended to be worn by<br>operating room personnel during surgical<br>procedure to protect both the surgical<br>patient and the operating room personnel<br>from transfer of microorganisms, body<br>fluids, and particulate material. Per<br>ANSI/AAMI PB70:2012 Liquid barrier<br>performance and classification of<br>protective apparel and drapes intended for<br>use in health care facilities, the surgical<br>gowns met the requirements for Level 3<br>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<br>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<4 | Log10<4 | Same |
| Material | SMMS nonwoven polypropylene | SMS polypropylene nonwoven + PE | Different<br>1.2 |
| Level | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | Same |
| Biocompatibility | | | |
| Cytotoxicity | According to ISO 10993-5: 2009, the test<br>material demonstrated no cytotoxic effect<br>under the condition of this study. | No Cytotoxicity | Same |
| Irritation | The test result showed that the irritant<br>response of the test article extract was<br>categorized as negligible under the test<br>condition. Complies with ISO 10993-<br>10:2010. | No Irritation | Same |
| Sensitization | Under the conditions of this study, the test<br>article extract showed no significant<br>evidence of causing skin sensitization in the<br>guinea pig. Complies with ISO 10993-<br>10:2010. | No Sensitization | Same |
| Sterile | Sterile | Sterile/Non-sterile | Same |
### Discussion
Sterile Level 3 Surgical Gown
The indications for use statement for the subject device is identical to the predicate device. There are no technological differences between the predicate and subject devices except for the following:
- . Different 1.1: The subject device is 50 gsm and the predicate device is 55 gsm. These slight differences have no adverse effect on clinical safety and performance. All of the subject device are tested in accordance with related standards given in Non-Clinical Testing Section of this summary. The requirements of the standards are met.
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Image /page/6/Picture/0 description: The image shows the logo for BARCO, a company that provides solutions for technical sportswear. The logo is displayed in a sans-serif font, with the "A" in BARCO replaced by a yellow triangle. Below the company name is the text "SOLUTIONS FOR TECHNICAL SPORTS WEAR" in a smaller font.
- Different 1.2: Subject device is made from SMS nonwoven polypropylene and the predicate device is made from SMS nonwoven polypropylene + PE. The subject device biocompatibility results and performance results demonstrate product safety. These slight differences have no adverse effect on clinical safety and performance. All of the subject device are tested in accordance with related standards given in Non-Clinical Testing Section of this summary. The requirements of the standards are met.
The intended use, principle of operation, materilization information for the subject device are the
same as the predicate device. The differences between the subject device do not raise any
new or different questions of safety or effectiveness.
### Non-Clinical Performance Testing
### Sterile Level 3 Surgical Gown
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 | Purpose | Acceptance<br>Criteria | Result |
|--------------------------------|----------------------------------------------|-------------------------------|---------------------------------------------------------|
| 16 CFR 1610 | Flammability of Textiles | Class 1 | Class 1 |
| ASTM D5034-09(2017) | Tensile Strength | ≥7 lbf | Warp:20,59 lbf, Weft: 30,48<br>lbf |
| ASTM D1683/<br>D1683M-17(2018) | Seam Strength<br>(Garment) | ≥7 lbf | RIGHT ARMHOLE SEAM<br>STRENGTH / SLIPPAGE: 8.1 lbf |
| ASTM D1683/<br>D1683M-17(2018) | Seam Strength<br>(Garment) | ≥7 lbf | LEFT ARMHOLE SEAM<br>STRENGTH / SLIPPAGE: 9.8 lbf |
| ASTM D1683/<br>D1683M-17(2018) | Seam Strength<br>(Garment) | ≥7 lbf | RIGHT SHOULDER SEAM<br>STRENGTH / SLIPPAGE: 14.1<br>lbf |
| ASTM D1683/<br>D1683M-17(2018) | Seam Strength<br>(Garment) | ≥7 lbf | LEFT SHOULDER SEAM<br>STRENGTH / SLIPPAGE: 14.7<br>lbf |
| ASTM D1683/<br>D1683M-17(2018) | Seam Strength<br>(Garment) | ≥7 lbf | RIGHT SLEEVE SEAM<br>STRENGTH / SLIPPAGE: 9.0 lbf |
| ASTM D1683/<br>D1683M-17(2018) | Seam Strength<br>(Garment) | ≥7 lbf | LEFT SLEEVE SEAM STRENGTH<br>/ SLIPPAGE: 9.1 lbf |
| ASTM D5587-15 (2019) | Tear Strength | ≥ 2.3 lbf | Warp:5,817 lbf, Weft: 8,958<br>lbf |
| ISO 9073-10 | EVALUATION OF<br>PARTICLES RELEASE | log 10 ≤4 | It is suitable according to ≤ 4<br>criteria. |
| AATCC 127:2017<br>Option 2 | Water Resistance:<br>Impact Penetration Test | ≥ 50 cm | 53,7 - 65,8 cm. LEVEL 3. |
| AATCC 42:2007 | Impact Penetration Test | no more than 1.0<br>grams (g) | Max 0.08. LEVEL 3 |
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| | | 510(k) Summary<br>Surgical Gown | | 07/21/202<br>Page 5 / 5 |
|--------------------------|------------------------------------------------------------------------------|-------------------------------------------------|---------------|-------------------------|
| ISO 10993-7: | EO Residue Test | 10µg/cm² | Not detected. | |
| ISO 10993-5 | Cytotoxicity | Not Cytotoxic | Not Cytotoxic | |
| ISO 10993-10 | Sensitization | Not Sensitive | Not Sensitive | |
| ISO 10993-10 | Irritation | Not Irritant | Not Irritant | |
| ASTM F88/F88M | Seal Strength of Flexible<br>Barrier Materials | Package Seal<br>integrity<br>must be<br>intact. | Passed | |
| ASTM F1929:2015 | Detecting Seal Leaks in<br>Porous Medical<br>Packaging by Dye<br>Penetration | No leakage<br>observe | Passed | |
| ASTM D3776 / D3776M - 20 | Mass Per Unit Area<br>(Weight) of Fabric | - | 50 GSM | |
# Clinical Performance Testing
The clinical performance testing is not applicable to the subject device.
# Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device.
