(500 days)
Not Found
No
The device is a surgical gown, and the description focuses on material properties, barrier performance, and standard testing, with no mention of AI or ML.
No.
The device (surgical gowns) is intended for protection from transfer of microorganisms, body fluids, and particulate material, not for therapy or treatment.
No
Explanation: The device is a surgical gown intended to protect against microorganisms and bodily fluids, not to diagnose medical conditions.
No
The device is a physical surgical gown made of nonwoven material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a protective barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the materials, construction, and physical characteristics of the gowns, all related to their barrier function.
- Performance Studies: The performance studies listed are related to the physical properties and barrier performance of the gowns (flammability, water resistance, penetration resistance, strength, etc.), not to any diagnostic capabilities.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro to provide information for diagnosis, monitoring, or screening. Surgical gowns do not perform this function.
N/A
Intended Use / Indications for Use
The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Dukal AAMI Level 3 Reinforced Surgical Gown and Sterile AAMI Level 3 Surgical Gown met the requirements for Level 3 classification; Dukal Sterile AAMI Level 4 Surgical Gown and Sterile AAMI Level 4 Splicing Surgical Gown met the requirements for Level 4 classification.
The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown are single use, disposable medical devices, and are provided sterile.
Product codes
FYA
Device Description
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. The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown are single use, disposable medical devices, and are provided sterile. Each type of Surgical Gown is available in six product sizes: M, L, XL, XXL, XXXL and XXXL-XL.
Dukal Sterile AAMI Level 3 Reinforced Surgical Gown and Sterile AAMI Level 3 Surgical Gown are made with SMS nonwoven material. The Dukal Sterile AAMI Level 4 Surgical Gown and Sterile AAMI Level 4 Splicing Surgical Gown are made with BVB material.
Only the Dukal Sterile AAMI Level 3 Reinforced Surgical Gown is reinforced with laminated material. Dukal Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, Sterile AAMI Level 4 Splicing Surgical Gown are non-reinforced.
Only the Sterile AAMI Level 4 Splicing Surgical gown has a different material for the back of the gown (SMS nonwoven fabric). The back of the gown for the Sterile AAMI Level 4 Surgical gown is made with BVB material.
All gowns are blue, with hook and loop closures, belt ties, and knitted cuff sleeves.
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 during surgical procedures in 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 Test Results:
The subject surgical gowns were tested and found conformance with the following standards:
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test
- AATCC 42:2017 Water Resistance: Impact Penetration Test
- ASTM F1671/F1671M-13 Standard Test Method for Resistance to Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage as a Test System
- ANSI AAMI PB70: 2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use in Health Care Facilities
- ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State
- ASTM D1683/D1683M-17:2017/(R)2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- ASTM D5733-99 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure
- ASTM D5034-09:2017 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- ASTM D737-18:2018 Standard Test Method for Air Permeability of Textile Fabrics
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7:Ethylene Oxide Sterilization Residuals
- ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
Summary for Non-Clinical Testing:
AAMI Level 3 Surgical Gowns showed:
- Impact penetration (AATCC 42): ≤1.0g (meets requirement)
- Hydrostatic pressure (AATCC 127): ≥50cm H2O (meets requirement)
- Tensile strength (ASTM D 5034): Latitude/Transverse: ≥30N, Longitude: ≥30N (meets requirement)
- Tear resistance (ASTM D 5733): Latitude/Transverse: ≥10N, Longitude: ≥10N (meets requirement)
- Seam strength (ASTM D 1683): ≥70N (meets requirement)
- Dye penetration (ASTM F 1929): No leakage (meets requirement)
- Sealing strength (ASTM F 88): ≥3N (180°) (meets requirement)
- Flammability (16 CFR Part 1610): Class I (meets requirement)
- Lint generation (ISO 9073-10): Size of particles counted: 3mcg-25mcg (meets requirement)
- Air permeability (ASTM D737): Test Pressure: 125Pa; Test area 38 cm² (meets requirement)
- Biocompatibility (ISO 10993-5, ISO 10993-10, ISO 10993-7): No cytotoxicity potential, negligible irritation, no significant evidence of delayed dermal contact sensitization. EO residuals within limits (meets requirement)
AAMI Level 4 Surgical Gowns showed:
- Blood-Borne Pathogens penetration (ASTM F1671): Pass (None Seen for Penetration of Phi-X174 Bacteriophage) (meets requirement)
- Impact penetration (AATCC 42): ≤1.0g (meets requirement)
- Hydrostatic pressure (AATCC 127): ≥120cm H2O (meets requirement)
- Tensile strength (ASTM D 5034): Latitude/Transverse: ≥30N, Longitude: ≥30N (meets requirement)
- Tear resistance (ASTM D 5733): Latitude/Transverse: ≥10N, Longitude: ≥10N (meets requirement)
- Seam strength (ASTM D 1683): ≥70N (meets requirement)
- Dye penetration (ASTM F 1929): No leakage (meets requirement)
- Sealing strength (ASTM F 88): ≥3N (180°) (meets requirement)
- Flammability (16 CFR Part 1610): Class I (meets requirement)
- Lint generation (ISO 9073-10): Size of particles counted: 3mcg-25mcg (meets requirement)
- Air permeability (ASTM D737): Test Pressure: 125Pa; Test area 38 cm² (meets requirement)
- Biocompatibility (ISO 10993-5, ISO 10993-10, ISO 10993-7): No cytotoxicity potential, negligible irritation, no significant evidence of delayed dermal contact sensitization. EO residuals within limits (meets requirement)
Summary for Clinical Testing: Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 7, 2022 Dukal Corporation Megan Quevedo Quality and Regulatory Affairs Engineer 2 Fleetwood Court Ronkonkoma, New York 11779
Re: K203237
Trade/Device Name: Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA
Dear Megan Quevedo:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 18, 2022. Specifically, FDA is updating this SE Letter for a correction to the 510(k) Summary as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, M.D., Ph.D., Office of Surgical and Infection Control Devices, at via phone: (301) 796-2261 or email: bifeng.qian@fda.hhs.gov.
Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Acting 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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 18, 2022
Dukal Corporation Megan Quevedo Quality and Regulatory Affairs Engineer 2 Fleetwood Court Ronkonkoma, New York 11779
Re: K203237
Trade/Device Name: Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: March 10, 2022 Received: March 16, 2022
Dear Megan Quevedo:
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.
2
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.
Clarence W. Murray III -S
Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K203237
Device Name
Dukal Sterile AAM Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
Indications for Use (Describe)
The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Dukal AAMI Level 3 Reinforced Surgical Gown and Sterile AAMI Level 3 Surgical Gown met the requirements for Level 3 classification; Dukal Sterile AAMI Level 4 Surgical Gown and Sterile AAMI Level 4 Splicing Surgical Gown met the requirements for Level 4 classification.
The Dukal Sterile AAM Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown are single use, disposable medical devices, and are provided sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) SUMMARY K203237 510(k) Premarket Notification for Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
| 1. Submitter: | Dukal, LLC
2 Fleetwood Court
Ronkonkoma NY 11779
Phone: 631-656-3800
Fax: 631-656-3810 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. FDA Registration Number: | 2435946 |
| 3. Regulatory Affairs Contact: | Megan Quevedo
Quality and Regulatory Affairs Supervisor
2 Fleetwood Court
Ronkonkoma NY 11779
Telephone Number: 631-656-3800 ext. 133
Fax Number: 631-656-3810 |
| 4. Date Summary Prepared: | April 7, 2022 |
| 5. Name of Device: | Dukal Sterile AAMI Level 3 Reinforced
Surgical Gown, Sterile AAMI Level 3 Surgical Gown,
Sterile AAMI Level 4 Surgical Gown, Sterile AAMI Level 4
Splicing Surgical Gown |
| 6. Trade Name: | Dukal Sterile AAMI Level 3 Reinforced
Surgical Gown, Sterile AAMI Level 3 Surgical Gown,
Sterile AAMI Level 4 Surgical Gown, Sterile AAMI Level 4
Splicing Surgical Gown |
| 7. Common/Classification Name: | Surgical Gowns |
| 8. Regulation Number: | 21 CFR §878.4040 |
| 9. Device Class: | Class II |
| 10. Regulation Name: | Surgical Apparel |
| 11. Product Code: | FYA |
| 12. Predicate Device: | Xuchang Zhengde Environstar Medical Products Co., Ltd |
5
SMS Standard Surgical Gown (level 3), SMS Surgical Gown with Reinforcement (level 3), BVB Surgical Gown (level 4), BVB Splicing Surgical Gown (level 4).
- 510k #K192290, cleared on 4/30/2020. .
13. Device Description:
- Packaging:
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. The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown are single use, disposable medical devices, and are provided sterile. Each type of Surgical Gown is available in six product sizes: M, L, XL, XXL, XXXL and XXXL-XL.
Dukal Sterile AAMI Level 3 Reinforced Surgical Gown and Sterile AAMI Level 3 Surgical Gown are made with SMS nonwoven material. The Dukal Sterile AAMI Level 4 Surgical Gown and Sterile AAMI Level 4 Splicing Surgical Gown are made with BVB material.
Only the Dukal Sterile AAMI Level 3 Reinforced Surgical Gown is reinforced with laminated material. Dukal Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, Sterile AAMI Level 4 Splicing Surgical Gown are non-reinforced.
Only the Sterile AAMI Level 4 Splicing Surgical gown has a different material for the back of the gown (SMS nonwoven fabric). The back of the gown for the Sterile AAMI Level 4 Surgical gown is made with BVB material.
All gowns are blue, with hook and loop closures, belt ties, and knitted cuff sleeves.
Packaging for Level 3 Gowns:
Sizes M and L: 1 gown/pouch, 28 pouches/case Sizes XL: 1 gown/pouch, 26 pouches/case Sizes XXL, XXXL and XXXL-XL: 1 gown/pouch, 24pouches/case
Packaging for Level 4 Gowns:
Sizes M: 1 gown/pouch, 28 pouches/case Sizes L and XL: 1 gown/pouch, 26 pouches/case
6
Sizes XXL, XXXL and XXXL-XL: 1 gown/pouch, 24pouches/case
- Indications for Use: The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Dukal AAMI Level 3 Reinforced Surgical Gown and Sterile AAMI Level 3 Surgical Gown met the requirements for Level 3 classification; Dukal Sterile AAMI Level 4 Surgical Gown and Sterile AAMI Level 4 Splicing Surgical Gown met the requirements for Level 4 classification. The Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown are single use, disposable medical devices, and are provided sterile.
16. Comparison of Technological Characteristics with the Predicate Device:
| Element of
Comparison | Predicate Device Xuchang
Zhengde Environstar Medical
Products Co., Ltd SMS
Standard Surgical Gown (Level
3) & SMS Surgical Gown with
Reinforcement (Level 3)
(K192290) | Subject Device Dukal
Sterile AAMI Level 3
Reinforced Surgical Gown
& Sterile AAMI Level 3
Surgical Gown | Comparison |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | 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. | 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. | Same |
| Style | Non-reinforced/Reinforced | Non-reinforced/Reinforced | Same |
| Weight per square (g/m²) | 50 g/m² for SMS Standard Surgical Gown (Level 3), 45 g/m² for SMS Surgical Gown with Reinforcement (Level 3) | 50 g/m² for Sterile AAMI Level 3 Surgical Gown, 45 g/m² for Sterile AAMI Level 3 Reinforced Surgical Gown | Same |
| Material Composition | SMS nonwoven, Laminated material (only for SMS Surgical Gown with Reinforcement (Level 3)), white knitted cuff, white spunbond | SMS nonwoven, Laminated material (only for Sterile AAMI Level 3 Reinforced Surgical Gown), white knitted cuff, white spunbond | Same |
| Regulation, Classification, Product Code | Regulation Number: 21 CFR §878.4040
Device Class: Class II
Regulation Name: Surgical Apparel
Product Code: FYA | Regulation Number: 21 CFR §878.4040
Device Class: Class II
Regulation Name: Surgical Apparel
Product Code: FYA | Same |
| Product Color | Blue | Blue | Same |
| Product Sizes | M, L, XL, XXL, XXXL and XXXL-XL | M, L, XL, XXL, XXXL and XXXL-XL | Same |
| Sterility | Sterile (EO) | Sterile (EO) | Similar |
| Level | Level 3 per AAMI PB70 | Level 3 per AAMI PB70 | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Biocompatibility | Under the conditions of each study, the Xuchang Zhengde Environstar Medical Products Co., Ltd SMS Standard Surgical Gown (Level 3) & SMS Surgical Gown with Reinforcement (Level 3) are non-cytotoxic (ISO 10993-5), are non-irritating (ISO 10993-10), and are non-sensitizing (ISO 10993-10) | Under the conditions of each study, the Dukal Sterile AAMI Level 3 Reinforced Surgical Gown & Sterile AAMI Level 3 Surgical Gown are non-cytotoxic (ISO 10993-5), are non-irritating (ISO 10993-10), and are non-sensitizing (ISO 10993-10) | Same |
AAMI Level 3 Surgical Gowns:
7
AAMI Level 4 Surgical Gown:
| Element of
Comparison | Predicate Device Xuchang
Zhengde Environstar Medical
Products Co., Ltd BVB Surgical
Gown (Level 4) & BVB Splicing
Surgical Gown (Level 4)
(K192290) | Subject Device Dukal
Sterile AAMI Level 4
Surgical Gown & Sterile
AAMI Level 4 Splicing
Surgical Gown | Comparison |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | 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. | The Dukal 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. | Same |
| Material
Composition | SMS nonwoven, white knitted
cuff, white spunbond, and BVB
Note: BVB Splicing Surgical
Gown (Level 4) has a different
material for the back of the
gown (SMS nonwoven fabric).
The back of the gown for the
BVB Surgical Gown (Level 4) is
made with BVB material. | SMS nonwoven, white
knitted cuff, white
spunbond, and BVB
Note: Sterile AAMI Level 4
Splicing Surgical gown has
a different material for
the back of the gown (SMS
nonwoven fabric). The
back of the gown for the
Sterile AAMI Level 4
Surgical gown is made
with BVB material. | Same |
| Regulation,
Classification,
Product Code | Regulation Number: 21 CFR
§878.4040
Device Class: Class II
Regulation Name: Surgical
Apparel
Product Code: FYA | Regulation Number: 21
CFR §878.4040
Device Class: Class II
Regulation Name: Surgical
Apparel
Product Code: FYA | Same |
| Product Color | Blue | Blue | Same |
| Style | Non-Reinforced | Non-Reinforced | Same |
| Weight per
square (g/m²) | For level 4 Surgical gown: 68
g/m² for gown body material
For level 4 Splicing Surgical
Gown: 68 g/m² for gown front
and sleeve material, with 40
g/m² for gown back material | For level 4 Surgical gown:
68 g/m² for gown body
material
For level 4 Splicing
Surgical Gown: 68 g/m²
for gown front and sleeve
material, with 40 g/m² for
gown back material | Same |
| Product Sizes | M, L, XL, XXL, XXXL and XXXL-XL | M, L, XL, XXL, XXXL and
XXXL-XL | Same |
| Sterility | Sterile (EO) | Sterile (EO) | Similar |
| Level | Level 4 per AAMI PB70 | Level 4 per AAMI PB70 | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Biocompatibility | | | |
| Biocompatibility | Under the conditions of each
study, the Xuchang Zhengde
Environstar Medical Products
Co., Ltd BVB Surgical Gown
(Level 4) & BVB Splicing Surgical
Gown (Level 4) are non-
cytotoxic (ISO 10993-5), are
non-irritating (ISO 10993-10),
and are non-sensitizing (ISO
10993-10). | Under the conditions of
each study, the Dukal
Sterile AAMI Level 4
Surgical Gown & Sterile
AAMI Level 4 Splicing
Surgical Gown are non-
cytotoxic (ISO 10993-5),
are non-irritating (ISO
10993-10), and are non-
sensitizing (ISO 10993-10). | Same |
8
9
Comparison Summary of Non-Clinical Testing Results
AAMI Level 3 Surgical Gowns:
| Test | Test Results of Predicate Device
Xuchang Zhengde Environstar
Medical Products Co., Ltd SMS
Standard Surgical Gown (Level 3)
& SMS Surgical Gown with
Reinforcement (Level 3)
(K192290) (Conforms to
ANSI/AAMI PB70:2012 Level 3
requirements) | Test Results of Subject Device
Dukal Sterile AAMI Level 3
Reinforced Surgical Gown &
Sterile AAMI Level 3 Surgical
Gown (Conforms to
ANSI/AAMI PB70:2012 Level
3 requirements) | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Flammability
(16 CFR 1610) | Class I | Class I | Same |
| Water
Resistance-
Hydrostatic
Pressure
(AATCC 127) | ≥50 cm H2O | ≥50 cm H2O | Same |
| Water
Resistance-
Impact
Penetration
(AATCC 42) | ≤1.0 g | ≤1.0 g | Same |
| Tensile strength
(ASTM D 5034) | Latitude/Transverse: ≥30N
Longitude: ≥30N | Latitude/Transverse: ≥30N
Longitude: ≥30N | Same |
| Tear strength
(ASTM D 5733) | Latitude/Transverse: ≥10N
Longitude: ≥10N | Latitude/Transverse: ≥10N
Longitude: ≥10N | Same |
| Seam Strength
(ASTM D 1683) | ≥70 N | ≥70 N | Same |
| Lint Generation
(ISO 9073-10) | Size of particles counted: 3mcg-25mcg | Size of particles counted: 3mcg-25mcg | Same |
| Air Permeability
(ASTM D737-18) | Test Pressure: 125Pa; Test area 38 cm² | Test Pressure: 125Pa; Test area 38 cm² | Same |
| Biocompatibility-Cytotoxicity
(ISO 10993-5),
Irritation & Sensitization
(ISO 10993-10);
EO Sterilization Residual (ISO 10993-7) | Under the conditions of the study, the device did not show cytotoxicity potential. Under the conditions of the study, the irritation response category of the device was classified as Negligible. Under the conditions of the study, the device showed no significant evidence of causing delayed dermal contact sensitization. For the sterile surgical gown: the device passed the Ethylene Oxide Sterilization Residuals testing. The residual of EO did not exceed 4mg/device and ECH did not exceed 9mg/device. The TCL of EO did not exceed 10 µg/cm² and ECH did not exceed 5000µg/cm². | Under the conditions of the study, the device did not show cytotoxicity potential. Under the conditions of the study, the irritation response category of the device was classified as Negligible. Under the conditions of the study, the device showed no significant evidence of causing delayed dermal contact sensitization. For the sterile surgical gown: the device passed the Ethylene Oxide Sterilization Residuals testing. The residual of EO did not exceed 4mg/device and ECH did not exceed 9mg/device. The TCL of EO did not exceed 10 µg/cm² and ECH did not exceed 5000µg/cm². | Same |
10
11
| AAMI Level 4 Surgical Gowns: | |||
|---|---|---|---|
| Test | Test Results of Predicate Device | ||
| Xuchang Zhengde Environstar | |||
| Medical Products Co., Ltd BVB | |||
| Surgical Gown (Level 4) & BVB | |||
| Splicing Surgical Gown (Level 4) | |||
| (K192290)(Conforms to | |||
| ANSI/AAMI PB70:2012 Level 4 | |||
| requirements) | Test Results of Subject Device | ||
| Dukal Sterile AAMI Level 4 | |||
| Surgical Gown & Sterile AAMI | |||
| Level 4 Splicing Surgical Gown | |||
| (Conforms to ANSI/AAMI | |||
| PB70:2012 Level 4 | |||
| requirements) | Comparison | ||
| Flammability | |||
| (16 CFR 1610) | Class I | ||
| Passed | Class I | ||
| Passed | Same | ||
| Resistance | |||
| Bacteriophage | |||
| Phi-X174 (ASTM | |||
| F1671/F1671M- |
-
| ≥120 cm H2O | ≥120 cm H2O | Same |
| Water
Resistance-
Hydrostatic
Pressure
(AATCC 127) | ≤1.0 g | ≤1.0 g | Same |
| Water
Resistance-
Impact
Penetration(AA
TCC 42) | ≤1.0 g | ≤1.0 g | Same |
| Tensile strength
(ASTM D 5034) | Latitude/Transverse: ≥30N
Longitude: ≥30N | Latitude/Transverse: ≥30N
Longitude: ≥30N | Same |
| Tear strength
ASTM D 5733 | Latitude/Transverse: ≥10N
Longitude: ≥10N | Latitude/Transverse: ≥10N
Longitude: ≥10N | Same |
| Seam Strength
(ASTM D 1683) | ≥70 N | ≥70 N | Same |
| Lint Generation
(ISO 9073-10) | Size of particles counted: 3mcg-
25mcg | Size of particles counted:
3mcg-25mcg | Same |
| Air Permeability
(ASTM D737-18) | Test Pressure: 125Pa; Test area
38 cm² | Test Pressure: 125Pa; Test
area 38 cm² | Same |
| Biocompatibility-Cytotoxicity
(ISO 10993-5),
Irritation &
Sensitization
(ISO 10993-10);
EO Sterilization
Residual (ISO
10993-7) | Under the
conditions of the study,
the device did not show
cytotoxicity potential. Under the
conditions of the study,
the irritation response
category of the device
was classified as
Negligible. Under the
conditions of the study,
the device showed no
significant evidence of
causing delayed dermal
contact sensitization. For the sterile
surgical gown: the device
passed the Ethylene
Oxide Sterilization
Residuals testing. The
residual of EO did not
exceed 4mg/device and
ECH did not exceed
9mg/device. The TCL of
EO did not exceed 10
µg/cm² and ECH did not
exceed 5000µg/cm². | Under the
conditions of the study,
the device did not show
cytotoxicity potential. Under the
conditions of the study,
the irritation response
category of the device
was classified as
Negligible. Under the
conditions of the study,
the device showed no
significant evidence of
causing delayed dermal
contact sensitization. For
the sterile surgical
gown: the device
passed the Ethylene
Oxide Sterilization
Residuals testing. The
residual of EO did not
exceed 4mg/device
and ECH did not
exceed 9mg/device.
The TCL of EO did not
exceed 10 µg/cm² and
ECH did not exceed
5000µg/cm². | Same |
12
Non-Clinical Test Results:
The subject surgical gowns were tested and found conformance with the following standards:
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles ●
- . AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test
- AATCC 42:2017 Water Resistance: Impact Penetration Test
- . ASTM F1671/F1671M-13 Standard Test Method for Resistance to Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage as a Test System
13
- ANSI AAMI PB70: 2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use in Health Care Facilities
- . ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State
- . ASTM D1683/D1683M-17:2017/(R)2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- . ASTM D5733-99 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure
- ASTM D5034-09:2017 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- ASTM D737-18:2018 Standard Test Method for Air Permeability of Textile Fabrics
- . ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- . ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7:Ethylene Oxide Sterilization Residuals
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
Summary for Non-Clinical Testing:
| Test Item | Test
Standard
Methods | Test Requirements | Test Results of Subject
Device Dukal Sterile AAMI
Level 3 Reinforced Surgical
Gown & Sterile AAMI Level
3 Surgical Gown | Remark |
|-----------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Impact
penetration | AATCC 42 | ≤1.0g (for AAMI Level 3) | ≤1.0g | Meets requirement |
| Hydrostatic
pressure | AATCC 127 | ≥50cm H2O (for AAMI
Level 3) | ≥50cm H2O | Meets requirement |
| Tensile strength | ASTM D
5034 | Latitude/Transverse:
≥30N
Longitude: ≥30N | Latitude/Transverse: ≥30N
Longitude: ≥30N | Meets requirement |
| Tear resistance | ASTM D
5733 | Latitude/Transverse:
≥10N
Longitude: ≥10N | Latitude/Transverse: ≥10N
Longitude: ≥10N | Meets requirement |
| Seam strength | ASTM D
1683 | ≥30N | ≥70N | Meets requirement |
| Dye penetration | ASTM F
1929 | No leakage | No leakage | Meets requirement |
| Sealing strength | ASTM F 88 | ≥3N (180°) | ≥3N (180°) | Meets requirement |
| Flammability | 16 CFR Part
1610 | Class I | Class I | Meets requirement |
| Lint generation | ISO 9073-10 | Size of particles
counted: 3mcg-25mcg | Size of particles counted:
3mcg-25mcg | Meets requirement |
| Air permeability | ASTM D737 | Test Pressure: 125Pa;
Test area 38 cm² | Test Pressure: 125Pa; Test
area 38 cm² | Meets requirement |
| Biocompatibility | ISO 10993-5
ISO 10993-
10
ISO 10993-7 | -Under the conditions
of the study, the device
does not show
cytotoxicity potential.
-Under the conditions
of the study, the
irritation response
category of the device
is classified as
Negligible.
-Under the conditions
of the study, the device
shows no significant
evidence of causing
delayed dermal contact
sensitization.
- The residual of EO
does not exceed
4mg/device and ECH
does not exceed
9mg/device. The TCL of
EO does not exceed 10
µg/cm² and ECH does
not exceed
5000µg/cm². | -Under the conditions of
the study, the device did
not show cytotoxicity
potential.
-Under the conditions of
the study, the irritation
response category of the
device was classified as
Negligible.
-Under the conditions of
the study, the device
showed no significant
evidence of causing delayed
dermal contact
sensitization. - The residual of EO did not
exceed 4mg/device and
ECH did not exceed
9mg/device. The TCL of EO
did not exceed 10 µg/cm²
and ECH did not exceed
5000µg/cm². | Meets requirement |
| Test Item | Test
Standard
Methods | Test Requirements | Test Results of Subject
Device Dukal Sterile AAMI
Level 4 Surgical Gown &
Sterile AAMI Level 4
Splicing Surgical Gown | Remark |
| Blood-Borne
Pathogens
penetration | ASTM
F1671 | Pass (For AAMI Level 4
Requirements): None
Seen for Penetration of
Phi-X174
Bacteriophage | Pass | Meets requirement |
| Impact
penetration | AATCC 42 | ≤1.0g | ≤1.0g | Meets requirement |
| Hydrostatic
pressure | AATCC 127 | ≥120cm H2O | ≥120cm H2O | Meets requirement |
| Tensile strength | ASTM D
5034 | Latitude/Transverse:
≥30N
Longitude: ≥30N | Latitude/Transverse: ≥30N
Longitude: ≥30N | Meets requirement |
| Tear resistance | ASTM D
5733 | Latitude/Transverse:
≥10N
Longitude: ≥10N | Latitude/Transverse: ≥10N
Longitude: ≥10N | Meets requirement |
| Seam strength | ASTM D
1683 | ≥30N | ≥70N | Meets requirement |
| Dye penetration | ASTM F
1929 | No leakage | No leakage | Meets requirement |
| Sealing strength | ASTM F 88 | ≥3N (180°) | ≥3N (180°) | Meets requirement |
| Flammability | 16 CFR
Part 1610 | Class I | Class I | Meets requirement |
| Lint generation | ISO 9073-
10 | Size of particles
counted: 3mcg-25mcg | Size of particles counted:
3mcg-25mcg | Meets requirement |
| Air permeability | ASTM
D737 | Test Pressure: 125Pa;
Test area 38 cm² | Test Pressure: 125Pa; Test
area 38 cm² | Meets requirement |
| | | -Under the conditions | -Under the conditions of | Meets requirement |
| | | | of the study, the device the study, the device did | |
| | | does not show | not show cytotoxicity | |
| | | cytotoxicity potential. | potential. | |
| | | -Under the conditions | -Under the conditions of | |
| | | of the study, the | the study, the irritation | |
| | | irritation response | response category of the | |
| | | category of the device | device was classified as | |
| Biocompatibility | ISO 10993-
5 | is classified as | Negligible. | |
| | | Negligible. | -Under the conditions of | |
| | | -Under the conditions | the study, the device | |
| | ISO 10993-
10 | of the study, the device | showed no significant | |
| | | shows no significant | evidence of causing delayed | |
| | | evidence of causing | dermal contact sensitization. | |
| | | delayed dermal contact
sensitization. | | |
| | | - The residual of EO | The residual of EO did not | |
| | | does not exceed | exceed 4mg/device and | |
| | | 4mg/device and ECH | ECH did not exceed | |
| | | does not exceed | 9mg/device. The TCL of EO | |
| | | 9mg/device. The TCL of | did not exceed 10 µg/cm² | |
| | | EO does not exceed 10
µg/cm² and ECH does
not exceed
5000µg/cm². | and ECH did not exceed
5000µg/cm². | |
| | | | | |
AAMI Level 3 Surgical Gowns:
14
15
AAMI Level 4 Surgical Gowns:
16
Summary for Clinical Testing: Not Applicable
Conclusions: The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission, Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, Sterile AAMI Level 4 Splicing Surgical Gown, are as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under K192290.