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510(k) Data Aggregation
(115 days)
Surgical Gown (Sterile); Surgical Gown (Non-sterile)
The proposed surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.
Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization validation to ISO 11135-1.
The proposed 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 proposed devices are single use, disposable medical devices and can be provided in sterile two types. Both the sterile and non-sterile surgical gowns are blue colored and available in six sizes, including S, M. L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.
The proposed surgical gowns are constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. It is a kind of non-reinforced surgical gown.
Here's a breakdown of the acceptance criteria and the study details for the Surgical Gown device (K221637), based on the provided document:
Acceptance Criteria and Device Performance
| Testing Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance Testing | |||
| Hydrostatic Pressure (AATCC 127-2018) | To measure the resistance of a fabric to the penetration of water under hydrostatic pressure | ≥50cm H2O | Passed. 3 non-consecutive lots tested, using a sample size of 32/lot. All parts of test specimen met the Level 3 requirements. |
| Water Resistance (AATCC 42-2017) | To verify the impact penetration of the device. | ≤1.0g | Passed. 3 non-consecutive lots tested, using a sample size of 32/lot. All parts of test specimen met the Level 3 requirements. |
| Tearing Strength (ASTM D5587-15 (2019)) | To determine the tearing strength of the device. | ≥10N | Passed. Sample size of 10 pcs. MD Mean: 34.39N, CD Mean: 18.06N. |
| Breaking Strength (ASTM D5034-09 (2017)) | To determine the breaking strength and elongation of the device. | ≥30N | Passed. Sample size of 10 pcs. MD Mean: 138.64N, CD Mean: 75.10N. |
| Seam Strength (ASTM D1683/D1683M-17(2018)) | To measure the sewn seam strength in surgical gown by applying a force perpendicular to the sewn seams | ≥30N | Passed. Sample size of 10 pcs. Mean 57.56 N. |
| Evaporative Resistance (ASTM F1868-17) | To measure the evaporative resistance under steady-state conditions of fabrics of the device. | ≤1.0kPa·m²/W | Passed. Sample size of 3pcs. 0.00315 kPa • m²/W. |
| Lint and other particles generation in the dry state (ISO 9073-10-2003) | To measure the linting of non-woven in the dry state. | Coefficient of linting Log₁₀≤4.0 | Passed. Sample size of 10pcs. Log₁₀ Mean: 2.7. |
| Flammability (16 CFR 1610) | To determine the flammability of textiles for the surgical gowns. | Class I | Passed. Sample size of 5 pcs. All samples are Class I. |
| Biocompatibility Testing | |||
| Cytotoxicity | Assess the potential risk of cytotoxicity of surgical gown material | Non-cytotoxic | Passed. Under the condition of this study, the device has no potential toxicity. |
| Irritation | Assess the potential risk of irritation of surgical gown material | Negligibly irritating | Passed. Under the condition of this study, the device is negligibly irritating. |
| Sensitization | Assess the potential risk of sensitization of surgical gown material | Non-sensitizing | Passed. Under the conditions of the study, the device is non-sensitizing. |
| Ethylene Oxide Residuals | Verify low levels of sterilant residuals | EO residual |
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(500 days)
Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI
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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(106 days)
Surgical Gown (Sterile), Surgical Gown (Non-sterile)
Surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.
The proposed devices 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 proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile two types. Both the sterile and non-sterile surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification.
This document is a 510(k) Summary for a Surgical Gown (Sterile) and Surgical Gown (Non-sterile). It describes the device, its intended use, and a comparison to predicate devices, focusing on non-clinical testing to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a "Technological Characteristic Comparison Table" (Table 2) that lists various performance criteria and the performance of the Subject Device (K202706). It implies that the acceptance criteria are met if the device's performance is similar to or meets the standards of the predicate devices or specified test methods.
| Item | Acceptance Criteria (Implied) | Reported Device Performance (Subject Device K202706) |
|---|---|---|
| Weight per square (g) | Similar to predicate (e.g., 50g/m², 45g/m², 68g/m² or 44g/m²) | 55g/m² |
| Size | Similar to predicate (e.g., M, L, XL, XXL, XXXL, XXXL-XLONG or XL) | S, M, L, XL, XXL, XXXL |
| Flammability | Class I (as per 16 CFR Part 1610) | Class I |
| Hydrostatic pressure | >50 cm (as per AATCC 127:2017) | >50 cm |
| Water impact | ≤1.0 g (as per AATCC 42:2017) | ≤1.0 g |
| Breaking strength | >20N (as per ASTM D5034:2017) | >20N |
| Tearing strength | >20N (as per ASTM D5587:2019) | >20N |
| Linting | Log1015cm³/s/cm² (29 ft³/min/ft²) or >30 ft³/min/ft² (as per ASTM D737:2018) | >30 ft³/min/ft² |
| Material | Similar to SMS polypropylene nonwoven | SMS polypropylene nonwoven + Polyester |
| Level | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 |
| Biocompatibility: Cytotoxicity | No Cytotoxicity (as per ISO 10993-5:2009) | No Cytotoxicity |
| Biocompatibility: Irritation | No Irritation (as per ISO 10993-10:2010) | No Irritation |
| Biocompatibility: Sensitization | No Sensitization (as per ISO 10993-10:2010) | No Sensitization |
| Sterile | Sterile/Non-sterile | Sterile/Non-sterile |
| Seal Strength | (Not explicitly stated in table, but ASTM F88/F88M:2015 implies a criterion) | (Test performed, results not explicitly shown in table) |
| Seal Leaks | (Not explicitly stated in table, but ASTM F1929:2015 implies a criterion) | (Test performed, results not explicitly shown in table) |
| EO Sterilization Residuals | (Not explicitly stated in table, but ISO 10993-7:2008 implies a criterion) | (Test performed, results not explicitly shown in table) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each non-clinical test or the provenance of the data (e.g., country of origin, retrospective/prospective). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The study involved non-clinical performance testing of a medical device (surgical gown), not studies requiring expert interpretation or ground truth establishment in a medical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessment.
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
This section is not applicable. No clinical studies, MRMC studies, or AI components are mentioned in this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a surgical gown; it does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests were established by the performance specifications outlined in recognized standards such as ANSI/AAMI PB70:2012, 16 CFR Part 1610, AATCC 127:2017, AATCC 42:2017, ISO 9073-10:2003, ASTM D1683/D1683M:2017/(R)2018, ASTM D5587:2019, ASTM D5034:2017, ASTM D737:2018, ASTM F88/F88M:2015, ASTM F1929:2015, ISO 10993-7:2008, ISO 10993-5:2009, and ISO 10993-10:2010.
8. The sample size for the training set
This section is not applicable. There is no mention of a "training set" as this is a non-clinical device performance study, not a machine learning or AI-based study.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set for this type of device submission.
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(36 days)
SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE
SurgiPlus Surgical Gowns are single use article of surgical apparel intended to be worn by operating room personnel during surgical and other medical procedures to protect both the medical personnel and patients from transfer of blood, body fluids, and particulate materials.
SurgiPlus Surgical Gowns are single use article of surgical apparel.
I'm sorry, but the provided text only contains a 510(k) premarket notification for a surgical gown and does not include information about acceptance criteria, study details, or performance data for a device. Therefore, I cannot generate the requested table and descriptions.
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