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Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:
A) Pre-vacuum Steam: 134℃ for 4 minutes, 30 minutes dry time.
B) Ethylene Oxide Sterilization: 100% Ethylene Oxide (EO) with a concentration of 360-363 mg/L @ 54°C and 40% relative humidity for 480 minutes, 24 hours aeration time at 42 ℃
Model: ZSW1610, ZSW 1611. Material: 45gms SMS, 54gms SMS. Color of wrap: Pink/Blue (double layers). Size (inches): 1212, 1515, 1818, 2020, 2424, 3030, 3636, 4040, 4545, 4848, 5454, 7254.
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post sterilization.
Types of medical devices to be sterilized in the Pre-Vacuum Steam Sterilization and Ethylene Oxide Sterilization: General purpose non-lumened reusable metal and nonmetal devices with stainless steel diffusion restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments etc. Models validated for both sterilization methods with stainless steel as part of the load, which with a maximum weight of each types, range from 21bs to 9lbs, which dependent on each model's size.
For size212, 1515, 1818, maximum weight is 216, for 2020, 3636, 4040, 4545, 4848, maximum weight is 6lb, and for 5454, 7254, maximum weight is 9lb.

Sterilization Wrap is square or rectangular three-layer (SMS) non-woven sheet which manufactured with Polypropylene spunbond-meltblown-spunbond (SMS) fabric. Sterilization wrap provides a strong barrier which protects against cuts, tears with particularly device sets. The device is designed to be implemented as an outer sterilization wrap which allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) up to 90 days post Pre-Vacuum Steam Sterilization or Ethylene Oxide Sterilization.
Sterilization Wrap is two-layer sheet which ultrasonically bonded blue and pink nonwoven sheet together along two edges, thus for convenient simultaneous wrapping.
Sterilization Wrap separated into two distinct types depending on different grams of weight of material, for ZSW 1610, it is two 45gsm SMS non-woven sheet ultrasonically bonded together, and for model ZSW 1611, it is two 54gsm SMS sheet. Each model contains series specification, including 12 Sizes (inches): 1212, 1515, 1818, 2020, 2424, 3030, 3636, 4040, 4545, 4848, 5454, 7254. With non-lumened reusable metal and nonmetal devices as part of the load, which with a maximum weight of each type, range from 21bs to 9lbs, which dependent on each model's size.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Sterilization Wrap (K223600).

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

The document presents the acceptance criteria and device performance as "Test Items" and "Test Result" (always "Pass"). The specific numerical/quantitative acceptance criteria are listed under "Standard and Acceptance Criteria".

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each of the non-clinical tests. It only states that the tests were conducted and "all results can meet standards requirements" or "Passed".

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective for each specific test. However, the submitter is "Wuhan Zonsen Medical Products Co., Ltd." located in Wuhan, Hubei, China, which implies the testing likely occurred in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the device is a medical accessory (sterilization wrap) and the validation involves non-clinical laboratory and performance testing, not expert interpretation of medical images or data requiring ground truth establishment by medical experts. The "ground truth" for this device's performance is established by meeting the specified international and national standards for physical properties, sterilization efficacy, and biocompatibility.

4. Adjudication method for the test set

This information is not applicable for the type of testing performed for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers for diagnostic accuracy, which is not relevant here.

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 information is not applicable. The device is a sterilization wrap, not an AI-powered diagnostic tool. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. As stated above, this is a physical medical accessory, not an algorithm or software device.

7. The type of ground truth used

The "ground truth" for this device's performance is based on established international and national standards for medical device physical properties, biocompatibility, and sterilization process validation (e.g., ASTM, AATCC, ISO standards). The "truth" is whether the device's measured properties and performance meet the predefined thresholds set by these standards.

8. The sample size for the training set

This information is not applicable. This is a physical medical device that undergoes manufacturing and quality control testing, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

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The Surgical Masks (model: ZSFM 23, ZSFM 24) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The proposed device (model: ZSFM 23) is blue color, four-layer, and flat pleated type mask, utilizing tie-on way for wearing, and it has nose clips design for fitting the face mask around the nose. The proposed device (model: ZSFM 24) is blue color, three-layer, and flat pleated type mask, utilizing ear loops way for wearing, and it has nose clips design for fitting the face mask around the nose.

The proposed device (model: ZSFM 23) is manufactured with four layers, the inner and outer layers are made of polypropylene non-woven fabric, and the two middle layers are made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of polypropylene non-woven fabric. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.

The proposed device (model: ZSFM 24) is manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene Melt blown non-woven fabric. The proposed device is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Spandex. The nose clip is fixed between the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable polyethylene wire.

The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.

Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Surgical Mask (Models ZSFM23 and ZSFM24)
Manufacturer: Wuhan Zonsen Medical Products Co., Ltd

1. Table of Acceptance Criteria and Reported Device Performance

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Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Examination Gloves are made from nitrile butadiene rubber that covers the hand up to the wrist. They are cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. The device is available in four sizes, which are S, M, L, XL. It could be selected by the user depending on the size of hand. All sizes share the same blue color. The gloves are non-sterile, powder free and are for single use only.

The provided document is a 510(k) summary for Nitrile Examination Gloves (Model: ZMG1351). It details the device's characteristics, comparison to a predicate device, and results from non-clinical testing. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Tensile Strength: Min 14Mpa
• Ultimate Elongation: Min 500%
  After Aging:
• Tensile Strength: Min 14Mpa
• Ultimate Elongation: Min 400% | Before Aging:
• Tensile Strength: 19.9~27.4Mpa
• Ultimate Elongation: 509~553%
  After Aging:
• Tensile Strength: 20.1~35.1Mpa
• Ultimate Elongation: 454~504% |
  | Freedom from Holes - ASTM D6319-19 | Detect the holes that allow water leakage | Do not show droplet, stream, or other type of water leakage (Pass at AQL 2.5, as per comparison table) | Performance reported as meeting the acceptance criteria (based on the "Test Results" column not explicitly stating values but confirming compliance with acceptance criteria for all tests) |
  | Powder Residue - ASTM D6319-19 | Evaluate the residue powder | ≤2mg/glove | Performance reported as meeting the acceptance criteria (based on the "Test Results" column not explicitly stating values but confirming compliance with acceptance criteria for all tests) |
  | Skin Irritation - ISO 10993-10:2010 | Evaluated for the potential to cause skin irritation | Under the condition of the test, not an irritant. | Performance reported as meeting the acceptance criteria (based on the "Test Results" column not explicitly stating values but confirming compliance with acceptance criteria for all tests) |
  | Sensitization - ISO 10993-10:2010 | Evaluated for the potential to cause skin sensitization | Under the condition of the test, not a sensitizer. | No-sensitization (Performance reported as meeting the acceptance criteria as per "No- sensitization" in "Test Results" column and confirmation of compliance for all tests) |
  | Acute Systemic Toxicity - ISO 10993-11:2017 | Evaluated for acute systemic toxicity | Under the condition of the test, not a systemic toxicity. | No-acute systemic toxicity (Performance reported as meeting the acceptance criteria as per "No- acute systemic toxicity" in "Test Results" column and confirmation of compliance for all tests) |

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the exact sample sizes used for each test. It simply states that "Bench tests were conducted to verify that the proposed device met all design specifications." The data provenance is not explicitly mentioned, but given the manufacturer (Wuhan Zonsen Medical Products Co.,Ltd) and contactor (Shanghai CV Technology Co., Ltd.) locations, it is highly likely the testing and data originated from China. The study appears to be retrospective in the sense that these are design verification tests performed on manufactured gloves.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable as the document describes physical and biocompatibility testing of medical gloves, not an AI or diagnostic device that requires expert interpretation to establish a ground truth. The "ground truth" for these tests is based on established international standards (ASTM and ISO).

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as above. The tests performed are objective measurements against predefined criteria in established standards.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, not for basic medical devices like examination gloves.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is a physical product (nitrile examination gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the acceptance criteria and testing of the Nitrile Examination Gloves is based on established industry standards and protocols:

• ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application.
• ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
• ISO 10993-11: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
  The tests measure physical properties and biological responses against scientifically defined and accepted limits.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI or machine learning device. The tests are for product verification and validation.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above.

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The Surgical Isolation Gown is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.

The Proposed device is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC and is a single use, disposable medical device provided non-sterile. The Surgical Isolation Gown is constructed of the neck tie, the waist belt, and elastic cuffs. The body fabric material is Polypropylene SMS non-woven, coated with Polyethylene. And all seams are reinforced by sealing tape of 100% Polyurethanes. The Surgical Isolation Gown is offered in blue with seven sizes ( S, M, L, XL, XXL, 3XL, 4XL).

The Surgical Isolation Gown 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 requirement.

The provided text describes the acceptance criteria and performance of the "Surgical Isolation Gown" (K212357) by Wuhan Zonsen Medical Products Co., Ltd. This is a non-clinical study, as stated in section I. Clinical Performance.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The sample size used for the performance tests (Flammability, Hydrostatic Pressure, Impact Penetration, Tensile Strength, Tearing Strength, Seam Strength, Linting, Evaporative Resistance) was 3 non-consecutive lots, with 32 samples per lot for average results.
The data provenance is not explicitly stated as country of origin, but the manufacturer is Wuhan Zonsen Medical Products Co., Ltd, in Wuhan, Hubei, China. The study is a non-clinical study (implicitly prospective as it's for a new device submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a non-clinical performance and biological evaluation of a medical device (surgical gown) based on standardized laboratory tests, not requiring expert ground truth in the clinical sense (e.g., radiologists interpreting images).

4. Adjudication method for the test set

Not applicable. The tests are based on objective physical and biological measurements according to established international and national standards.

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. This document pertains to the performance testing of a physical medical device (surgical isolation gown), not an AI-assisted diagnostic or clinical decision support tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for the device's performance is established by the standardized test methods and their defined requirements/criteria. For example:

• Physical properties (e.g., tensile strength, tear strength, barrier performance) use established engineering and material science standards (e.g., ASTM, AATCC, ANSI/AAMI PB70:2012).
• Biocompatibility (cytotoxicity, irritation, sensitization) uses internationally recognized ISO standards (ISO 10993 series).

8. The sample size for the training set

Not applicable. This is a non-clinical study for a physical medical device, not a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, for the same reason as point 8.

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Surgical Gown is intended to be worn by room personnel during surgical procedures or other invasive tests to protect both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This is single use, disposable device, provided sterile.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 2 classification, and the reinforced surgical gowns met the requirements for Level 3 classification.

The proposed devices Surgical Gown / Reinforced Surgical Gown have two models: ZSG1005 and ZSG1006.

The proposed device Surgical Gown is model ZSG1005, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in M, L, XL sizes. This proposed device can meet the requirements for Level 2 per ANSI/AAMI PB70:2012.

The proposed device Reinforced Surgical Gown is model ZSG1006, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in M. L. XL sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.

The proposed devices are disposable medical devices and provided in sterile.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Surgical Gown, Reinforced Surgical Gown (Wuhan Zonsen Medical Products Co.,Ltd)

1. Table of acceptance criteria and the reported device performance:

8. The sample size for the training set:

• Not applicable. This device is a physical product, not a machine learning model, therefore, there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable. As there is no training set, there is no ground truth established for it.

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The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Surgical Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip.
Two layers of polypropylene non-woven fabric, with a layer of polypropylene melt-blown filter cloth in the middle; plastic nose clip, ear loop is spandex elastic belt.
The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are not made with natural rubber latex.
The nose clip in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire.
The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.

This document describes the acceptance criteria and performance of the Wuhan Zonsen Medical Products Co., Ltd SURGICAL MASK (Model: ZSFM 21, barrier level 2, blue).

1. Table of Acceptance Criteria and Reported Device Performance:

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