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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.

Device Description

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.

AI/ML Overview

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.

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.
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.
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.
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.
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.
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.
The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.
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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