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510(k) Data Aggregation
(115 days)
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 < 4mg/piece, ECH < 9mg/piece | Passed. The EO/ECH residuals shown in test report are far below the criteria. |
Study Information
The provided document describes non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than a study involving human subjects or artificial intelligence.
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Sample size used for the test set and the data provenance:
- Hydrostatic Pressure: 3 non-consecutive lots, with a sample size of 32 per lot.
- Water Resistance: 3 non-consecutive lots, with a sample size of 32 per lot.
- Tearing Strength: 10 pieces.
- Breaking Strength: 10 pieces.
- Seam Strength: 10 pieces.
- Evaporative Resistance: 3 pieces.
- Lint and other particles generation: 10 pieces.
- Flammability: 5 pieces.
- Biocompatibility (Cytotoxicity, Irritation, Sensitization): Not explicitly stated, but the tests were performed "Under the condition of this study" or "Under the conditions of the study."
- Ethylene Oxide Residuals: Not explicitly stated, but "shown in test report."
- Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being in Hubei, China. The studies are non-clinical, likely laboratory tests, not retrospective or prospective patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This involves non-clinical laboratory testing against established physical and chemical standards, not expert evaluation of medical images or conditions where a "ground truth" established by experts would be relevant.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a study involving human reviewers or interpretation that would require an adjudication method. The results are based on objective measurements against specified standards.
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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. This is a submission for a surgical gown, not an AI-assisted diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device (surgical gown), not an algorithm.
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The type of ground truth used: The "ground truth" in this context is the predefined acceptance criteria set forth by established international and national standards (e.g., ANSI/AAMI PB70:2012, ASTM, ISO, AATCC, CFR standards). The device's performance is measured against these objective criteria.
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The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.
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(106 days)
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 | Log10<4 (as per ISO 9073-10:2003) | Log10<4 |
| Air permeability | >15cm³/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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