(500 days)
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.
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.
This document describes a 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. The submission establishes substantial equivalence to a predicate device (K192290: Xuchang Zhengde Environstar Medical Products Co., Ltd SMS Standard Surgical Gown (level 3), SMS Surgical Gown with Reinforcement (level 3), BVB Surgical Gown (level 4), BVB Splicing Surgical Gown (level 4)).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally "Same" as the predicate device or "Meets requirement" based on specific test standards. The reported device performance consistently meets these criteria.
AAMI Level 3 Surgical Gowns:
| Test Item | Test Standard Methods | Acceptance Criteria (Test Requirements) | Reported Device Performance (Test Results of Subject Device) |
|---|---|---|---|
| Flammability | 16 CFR 1610 | Class I | Class I |
| Water Resistance-Hydrostatic Pressure | AATCC 127 | ≥50 cm H2O (for AAMI Level 3) | ≥50 cm H2O |
| Water Resistance-Impact Penetration | AATCC 42 | ≤1.0 g (for AAMI Level 3) | ≤1.0 g |
| Tensile strength | ASTM D 5034 | Latitude/Transverse: ≥30N, Longitude: ≥30N | Latitude/Transverse: ≥30N, Longitude: ≥30N |
| Tear strength | ASTM D 5733 | Latitude/Transverse: ≥10N, Longitude: ≥10N | Latitude/Transverse: ≥10N, Longitude: ≥10N |
| Seam Strength | ASTM D 1683 | ≥30N (Predicate states ≥70N, Subject device meets ≥70N) | ≥70N |
| Lint Generation | ISO 9073-10 | Size of particles counted: 3mcg-25mcg | Size of particles counted: 3mcg-25mcg |
| Air Permeability | ASTM D737-18 | Test Pressure: 125Pa; Test area 38 cm² | Test Pressure: 125Pa; Test area 38 cm² |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization) | ISO 10993-5, ISO 10993-10 | Non-cytotoxic, Negligible irritation, No significant evidence of delayed dermal contact sensitization | Did not show cytotoxicity potential, Irritation response category classified as Negligible, Showed no significant evidence of causing delayed dermal contact sensitization |
| EO Sterilization Residual | ISO 10993-7 | EO ≤ 4mg/device, ECH ≤ 9mg/device, TCL of EO ≤ 10 µg/cm², TCL of ECH ≤ 5000µg/cm² | Residual of EO did not exceed 4mg/device, ECH did not exceed 9mg/device, TCL of EO did not exceed 10 µg/cm², ECH did not exceed 5000µg/cm² |
AAMI Level 4 Surgical Gowns:
| Test Item | Test Standard Methods | Acceptance Criteria (Test Requirements) | Reported Device Performance (Test Results of Subject Device) |
|---|---|---|---|
| Flammability | 16 CFR 1610 | Class I | Class I |
| Resistance to Bacteriophage Phi-X174 | ASTM F1671/F1671M-13 | Pass (None Seen for Penetration of Phi-X174 Bacteriophage) | Pass |
| Water Resistance-Hydrostatic Pressure | AATCC 127 | ≥120 cm H2O | ≥120 cm H2O |
| Water Resistance-Impact Penetration | AATCC 42 | ≤1.0 g | ≤1.0 g |
| Tensile strength | ASTM D 5034 | Latitude/Transverse: ≥30N, Longitude: ≥30N | Latitude/Transverse: ≥30N, Longitude: ≥30N |
| Tear strength | ASTM D 5733 | Latitude/Transverse: ≥10N, Longitude: ≥10N | Latitude/Transverse: ≥10N, Longitude: ≥10N |
| Seam Strength | ASTM D 1683 | ≥30N (Predicate states ≥70N, Subject device meets ≥70N) | ≥70N |
| Lint Generation | ISO 9073-10 | Size of particles counted: 3mcg-25mcg | Size of particles counted: 3mcg-25mcg |
| Air Permeability | ASTM D737-18 | Test Pressure: 125Pa; Test area 38 cm² | Test Pressure: 125Pa; Test area 38 cm² |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization) | ISO 10993-5, ISO 10993-10 | Non-cytotoxic, Negligible irritation, No significant evidence of delayed dermal contact sensitization | Did not show cytotoxicity potential, Irritation response category classified as Negligible, Showed no significant evidence of causing delayed dermal contact sensitization |
| EO Sterilization Residual | ISO 10993-7 | EO ≤ 4mg/device, ECH ≤ 9mg/device, TCL of EO ≤ 10 µg/cm², TCL of ECH ≤ 5000µg/cm² | Residual of EO did not exceed 4mg/device, ECH did not exceed 9mg/device, TCL of EO did not exceed 10 µg/cm², ECH did not exceed 5000µg/cm² |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test in the "Test Results of Subject Device" columns. However, it indicates that the tests conform to recognized standards (e.g., AATCC, ASTM, ISO). These standards typically specify minimum sample sizes for each test.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. It is assumed to be prospective testing conducted on the finished device to demonstrate compliance with the referenced standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a submission for a physical medical device (surgical gowns) and not an AI/software device. Therefore, the concept of "experts used to establish ground truth" (e.g., radiologists) in the context of diagnostic interpretation is not applicable here. The "ground truth" is established by direct measurement and testing against established physical and chemical standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication of diagnostic findings. The tests are based on objective physical and chemical measurements following established laboratory protocols.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. An MRMC study is relevant for AI-powered diagnostic devices, which is not the case for surgical gowns.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth is based on recognized consensus standards for physical and chemical testing of surgical apparel, such as:
- ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes
- 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
- 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
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.
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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
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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.
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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 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
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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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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, LLC2 Fleetwood CourtRonkonkoma NY 11779Phone: 631-656-3800Fax: 631-656-3810 |
|---|---|
| 2. FDA Registration Number: | 2435946 |
| 3. Regulatory Affairs Contact: | Megan QuevedoQuality and Regulatory Affairs Supervisor2 Fleetwood CourtRonkonkoma NY 11779Telephone Number: 631-656-3800 ext. 133Fax Number: 631-656-3810 |
| 4. Date Summary Prepared: | April 7, 2022 |
| 5. Name of Device: | Dukal Sterile AAMI Level 3 ReinforcedSurgical Gown, Sterile AAMI Level 3 Surgical Gown,Sterile AAMI Level 4 Surgical Gown, Sterile AAMI Level 4Splicing Surgical Gown |
| 6. Trade Name: | Dukal Sterile AAMI Level 3 ReinforcedSurgical Gown, Sterile AAMI Level 3 Surgical Gown,Sterile AAMI Level 4 Surgical Gown, Sterile AAMI Level 4Splicing 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 |
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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
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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 ofComparison | Predicate Device XuchangZhengde Environstar MedicalProducts Co., Ltd SMSStandard Surgical Gown (Level3) & SMS Surgical Gown withReinforcement (Level 3)(K192290) | Subject Device DukalSterile AAMI Level 3Reinforced Surgical Gown& Sterile AAMI Level 3Surgical Gown | Comparison |
|---|---|---|---|
| Indications forUse | Surgical gown is intended to beworn by operating roompersonnel during surgicalprocedure to protect both thesurgical patient and theoperating room personnel fromtransfer of microorganisms,body fluids, and particulatematerial. | Surgical gown is intendedto be worn by operatingroom personnel duringsurgical procedures toprotect both the surgicalpatient and the operatingroom personnel fromtransfer ofmicroorganisms, bodyfluids, and particulatematerial. | 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 §878.4040Device Class: Class IIRegulation Name: Surgical ApparelProduct Code: FYA | Regulation Number: 21 CFR §878.4040Device Class: Class IIRegulation Name: Surgical ApparelProduct 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:
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AAMI Level 4 Surgical Gown:
| Element ofComparison | Predicate Device XuchangZhengde Environstar MedicalProducts Co., Ltd BVB SurgicalGown (Level 4) & BVB SplicingSurgical Gown (Level 4)(K192290) | Subject Device DukalSterile AAMI Level 4Surgical Gown & SterileAAMI Level 4 SplicingSurgical Gown | Comparison |
|---|---|---|---|
| Indications forUse | Surgical gown is intended to beworn by operating roompersonnel during surgicalprocedure to protect both thesurgical patient and theoperating room personnel fromtransfer of microorganisms,body fluids, and particulatematerial. | The Dukal surgical gownsare intended to be wornby operating roompersonnel during surgicalprocedures to protectboth the surgical patientand the operating roompersonnel from transfer ofmicroorganisms, bodyfluids, and particulatematerial. | Same |
| MaterialComposition | SMS nonwoven, white knittedcuff, white spunbond, and BVBNote: BVB Splicing SurgicalGown (Level 4) has a differentmaterial for the back of thegown (SMS nonwoven fabric).The back of the gown for theBVB Surgical Gown (Level 4) ismade with BVB material. | SMS nonwoven, whiteknitted cuff, whitespunbond, and BVBNote: Sterile AAMI Level 4Splicing Surgical gown hasa different material forthe back of the gown (SMSnonwoven fabric). Theback of the gown for theSterile AAMI Level 4Surgical gown is madewith BVB material. | Same |
| Regulation,Classification,Product Code | Regulation Number: 21 CFR§878.4040Device Class: Class IIRegulation Name: SurgicalApparelProduct Code: FYA | Regulation Number: 21CFR §878.4040Device Class: Class IIRegulation Name: SurgicalApparelProduct Code: FYA | Same |
| Product Color | Blue | Blue | Same |
| Style | Non-Reinforced | Non-Reinforced | Same |
| Weight persquare (g/m²) | For level 4 Surgical gown: 68g/m² for gown body materialFor level 4 Splicing SurgicalGown: 68 g/m² for gown frontand sleeve material, with 40g/m² for gown back material | For level 4 Surgical gown:68 g/m² for gown bodymaterialFor level 4 SplicingSurgical Gown: 68 g/m²for gown front and sleevematerial, with 40 g/m² forgown back material | Same |
| Product Sizes | M, L, XL, XXL, XXXL and XXXL-XL | M, L, XL, XXL, XXXL andXXXL-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 eachstudy, the Xuchang ZhengdeEnvironstar Medical ProductsCo., Ltd BVB Surgical Gown(Level 4) & BVB Splicing SurgicalGown (Level 4) are non-cytotoxic (ISO 10993-5), arenon-irritating (ISO 10993-10),and are non-sensitizing (ISO10993-10). | Under the conditions ofeach study, the DukalSterile AAMI Level 4Surgical Gown & SterileAAMI Level 4 SplicingSurgical Gown are non-cytotoxic (ISO 10993-5),are non-irritating (ISO10993-10), and are non-sensitizing (ISO 10993-10). | Same |
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Comparison Summary of Non-Clinical Testing Results
AAMI Level 3 Surgical Gowns:
| Test | Test Results of Predicate DeviceXuchang Zhengde EnvironstarMedical Products Co., Ltd SMSStandard Surgical Gown (Level 3)& SMS Surgical Gown withReinforcement (Level 3)(K192290) (Conforms toANSI/AAMI PB70:2012 Level 3requirements) | Test Results of Subject DeviceDukal Sterile AAMI Level 3Reinforced Surgical Gown &Sterile AAMI Level 3 SurgicalGown (Conforms toANSI/AAMI PB70:2012 Level3 requirements) | Comparison |
|---|---|---|---|
| Flammability(16 CFR 1610) | Class I | Class I | Same |
| WaterResistance-HydrostaticPressure(AATCC 127) | ≥50 cm H2O | ≥50 cm H2O | Same |
| WaterResistance-ImpactPenetration(AATCC 42) | ≤1.0 g | ≤1.0 g | Same |
| Tensile strength(ASTM D 5034) | Latitude/Transverse: ≥30NLongitude: ≥30N | Latitude/Transverse: ≥30NLongitude: ≥30N | Same |
| Tear strength(ASTM D 5733) | Latitude/Transverse: ≥10NLongitude: ≥10N | Latitude/Transverse: ≥10NLongitude: ≥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 |
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| AAMI Level 4 Surgical Gowns: | |||
|---|---|---|---|
| Test | Test Results of Predicate DeviceXuchang Zhengde EnvironstarMedical Products Co., Ltd BVBSurgical Gown (Level 4) & BVBSplicing Surgical Gown (Level 4)(K192290)(Conforms toANSI/AAMI PB70:2012 Level 4requirements) | Test Results of Subject DeviceDukal Sterile AAMI Level 4Surgical Gown & Sterile AAMILevel 4 Splicing Surgical Gown(Conforms to ANSI/AAMIPB70:2012 Level 4requirements) | Comparison |
| Flammability(16 CFR 1610) | Class IPassed | Class IPassed | Same |
| ResistanceBacteriophagePhi-X174 (ASTMF1671/F1671M-13) | ≥120 cm H2O | ≥120 cm H2O | Same |
| WaterResistance-HydrostaticPressure(AATCC 127) | ≤1.0 g | ≤1.0 g | Same |
| WaterResistance-ImpactPenetration(AATCC 42) | ≤1.0 g | ≤1.0 g | Same |
| Tensile strength(ASTM D 5034) | Latitude/Transverse: ≥30NLongitude: ≥30N | Latitude/Transverse: ≥30NLongitude: ≥30N | Same |
| Tear strengthASTM D 5733 | Latitude/Transverse: ≥10NLongitude: ≥10N | Latitude/Transverse: ≥10NLongitude: ≥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 area38 cm² | Test Pressure: 125Pa; Testarea 38 cm² | Same |
| Biocompatibility-Cytotoxicity(ISO 10993-5),Irritation &Sensitization(ISO 10993-10);EO SterilizationResidual (ISO10993-7) | Under theconditions of the study,the device did not showcytotoxicity potential. Under theconditions of the study,the irritation responsecategory of the devicewas classified asNegligible. Under theconditions of the study,the device showed nosignificant evidence ofcausing delayed dermalcontact sensitization. For the sterilesurgical gown: the devicepassed the EthyleneOxide SterilizationResiduals testing. Theresidual of EO did notexceed 4mg/device andECH did not exceed9mg/device. The TCL ofEO did not exceed 10µg/cm² and ECH did notexceed 5000µg/cm². | Under theconditions of the study,the device did not showcytotoxicity potential. Under theconditions of the study,the irritation responsecategory of the devicewas classified asNegligible. Under theconditions of the study,the device showed nosignificant evidence ofcausing delayed dermalcontact sensitization. Forthe sterile surgicalgown: the devicepassed the EthyleneOxide SterilizationResiduals testing. Theresidual of EO did notexceed 4mg/deviceand ECH did notexceed 9mg/device.The TCL of EO did notexceed 10 µg/cm² andECH did not exceed5000µg/cm². | Same |
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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
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- 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 | TestStandardMethods | Test Requirements | Test Results of SubjectDevice Dukal Sterile AAMILevel 3 Reinforced SurgicalGown & Sterile AAMI Level3 Surgical Gown | Remark |
|---|---|---|---|---|
| Impactpenetration | AATCC 42 | ≤1.0g (for AAMI Level 3) | ≤1.0g | Meets requirement |
| Hydrostaticpressure | AATCC 127 | ≥50cm H2O (for AAMILevel 3) | ≥50cm H2O | Meets requirement |
| Tensile strength | ASTM D5034 | Latitude/Transverse:≥30NLongitude: ≥30N | Latitude/Transverse: ≥30NLongitude: ≥30N | Meets requirement |
| Tear resistance | ASTM D5733 | Latitude/Transverse:≥10NLongitude: ≥10N | Latitude/Transverse: ≥10NLongitude: ≥10N | Meets requirement |
| Seam strength | ASTM D1683 | ≥30N | ≥70N | Meets requirement |
| Dye penetration | ASTM F1929 | No leakage | No leakage | Meets requirement |
| Sealing strength | ASTM F 88 | ≥3N (180°) | ≥3N (180°) | Meets requirement |
| Flammability | 16 CFR Part1610 | Class I | Class I | Meets requirement |
| Lint generation | ISO 9073-10 | Size of particlescounted: 3mcg-25mcg | Size of particles counted:3mcg-25mcg | Meets requirement |
| Air permeability | ASTM D737 | Test Pressure: 125Pa;Test area 38 cm² | Test Pressure: 125Pa; Testarea 38 cm² | Meets requirement |
| Biocompatibility | ISO 10993-5ISO 10993-10ISO 10993-7 | -Under the conditionsof the study, the devicedoes not showcytotoxicity potential.-Under the conditionsof the study, theirritation responsecategory of the deviceis classified asNegligible.-Under the conditionsof the study, the deviceshows no significantevidence of causingdelayed dermal contactsensitization.- The residual of EOdoes not exceed4mg/device and ECHdoes not exceed9mg/device. The TCL ofEO does not exceed 10µg/cm² and ECH doesnot exceed5000µg/cm². | -Under the conditions ofthe study, the device didnot show cytotoxicitypotential.-Under the conditions ofthe study, the irritationresponse category of thedevice was classified asNegligible.-Under the conditions ofthe study, the deviceshowed no significantevidence of causing delayeddermal contactsensitization.- The residual of EO did notexceed 4mg/device andECH did not exceed9mg/device. The TCL of EOdid not exceed 10 µg/cm²and ECH did not exceed5000µg/cm². | Meets requirement |
| Test Item | TestStandardMethods | Test Requirements | Test Results of SubjectDevice Dukal Sterile AAMILevel 4 Surgical Gown &Sterile AAMI Level 4Splicing Surgical Gown | Remark |
| Blood-BornePathogenspenetration | ASTMF1671 | Pass (For AAMI Level 4Requirements): NoneSeen for Penetration ofPhi-X174Bacteriophage | Pass | Meets requirement |
| Impactpenetration | AATCC 42 | ≤1.0g | ≤1.0g | Meets requirement |
| Hydrostaticpressure | AATCC 127 | ≥120cm H2O | ≥120cm H2O | Meets requirement |
| Tensile strength | ASTM D5034 | Latitude/Transverse:≥30NLongitude: ≥30N | Latitude/Transverse: ≥30NLongitude: ≥30N | Meets requirement |
| Tear resistance | ASTM D5733 | Latitude/Transverse:≥10NLongitude: ≥10N | Latitude/Transverse: ≥10NLongitude: ≥10N | Meets requirement |
| Seam strength | ASTM D1683 | ≥30N | ≥70N | Meets requirement |
| Dye penetration | ASTM F1929 | No leakage | No leakage | Meets requirement |
| Sealing strength | ASTM F 88 | ≥3N (180°) | ≥3N (180°) | Meets requirement |
| Flammability | 16 CFRPart 1610 | Class I | Class I | Meets requirement |
| Lint generation | ISO 9073-10 | Size of particlescounted: 3mcg-25mcg | Size of particles counted:3mcg-25mcg | Meets requirement |
| Air permeability | ASTMD737 | Test Pressure: 125Pa;Test area 38 cm² | Test Pressure: 125Pa; Testarea 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 contactsensitization. | ||||
| - 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 10µg/cm² and ECH doesnot exceed5000µg/cm². | and ECH did not exceed5000µg/cm². | |||
AAMI Level 3 Surgical Gowns:
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AAMI Level 4 Surgical Gowns:
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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.
§ 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.