(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.
§ 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.