(125 days)
Gown is a single use, disposable, non-solation gown intended to be worn by healthcare personnel to provide moderate barrier protection (AAMI Level 3) in non-sterile and non-patient isolation situations.
The Medline Open-Back Level 3 Protective Gown is a single use, disposable, non-sterile, nonisolation gown intended to be worn by healthcare personnel to provide moderate barrier protection (AAMI Level 3) in non-sterile and non-patient isolation situation. The Medline Open-Back Level 3 Protective Gown meets the level 3 barrier protection requirements in accordance with ANSI/AAMI Standard PB70:2012 "Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for use in Health Care Facilities".
The Medline Open-Back Level 3 Protective Gown is a blue polyethylene gown available in 3 configurations: regular/large, universal and XL. The gown has an open back with a tie for securement and thumb loops on the cuffs.
The document provided is a 510(k) summary for the Medline Open-Back Level 3 Protective Gown. It describes the device, its intended use, and a comparison to a predicate device. The information details non-clinical performance and biocompatibility testing results.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Test scores 0.4). | Pass |
| Performance Testing | ||
| Tearing Strength/Resistance (ASTM D5587) | The average tear strength in both Machine and Cross-Machine Directions was assessed per ASTM F2407 – 2020. | Pass (Specific numerical results reported in the comparison table on page 5: 15.98±0.68N (Machine Direction) and 9.41±0.46N (Transverse Direction)) |
| Tensile Strength (ASTM D5034) | The average tensile strength in both Machine and Cross-Machine Directions was assessed per ASTM F2407 - 2020. | Pass (Specific numerical results reported in the comparison table on page 5: 41.74±2.74N (Machine Direction) and 30.29±3.52N (Transverse Direction)) |
| Seam Strength (ASTM D1683) | The average seam strength values were assessed per ASTM F2407 - 2020. | Pass (Specific numerical results reported in the comparison table on page 5: 35.01±3.91 N and 7.87±0.88 lb) |
| Hydrostatic Pressure Test (AATCC 127) | ≥50cm | Pass |
| Impact Penetration (AATCC 42) | ≤1.0g | Pass |
| Mass Per Unit Area (Weight) of Woven Fabric (ASTM D3776/D3776M) | Basis Weight per ASTM D3776/D3776M | Lot 1: 27.67 ± 0.58 / Lot 2: 28.00 ± 3.46 / Lot 3: 30.67 ± 0.58 |
| Tensile Properties of Thin Plastic Sheeting (ASTM D882) | Determination of tensile properties of plastics in the form of thin sheeting and films (less than 1.0 mm (0.04 in.) in thickness). | Average Machine data for 3 Lots: Load at Break (N) 12.79±1.21; Tensile Strength (Mpa) 16.64±3.40; % Elongation at Break 410.76±50.67. Average Cross data for 3 Lots: Load at Break (N) 10.19±1.03; Tensile Strength (Mpa) 11.43±3.95; %Elongation at Break 522.42±58.80. |
| Tear Resistance (Graves Tear) of Plastic Film and Sheeting (ASTM D1004) | Determination of the tear resistance of flexible plastic film and sheeting at very low rates of loading, 51 mm (2 in.)/min. | Average Machine data for 3 Lots: Maximum Load (N) 2.93±0.34; Extension at Break (mm) 19.84±3.57. Average Cross data for 3 Lots: Maximum Load (N) 3.23±0.20; Extension at Break (mm) 22.50±1.4. |
| Flammability of Clothing Textiles (16 CFR Part 1610) | Average burn time ≥ 3.5s; Class 1 "normal Flammability" in accordance to 16 CFR Part 1610. | Pass |
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 explicitly state the specific sample size for each individual test (e.g., how many gowns were tested for tear strength). However, it implies that the tests were conducted on representative samples of the Medline Open-Back Level 3 Protective Gown. The provenance of the data is not specified (e.g., country of origin or whether it was retrospective or prospective). It is generally assumed that such testing is prospective, meaning it's performed specifically for the regulatory submission.
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 is not applicable to the type of device and testing performed. The device is a protective gown, and its performance is evaluated through standardized physical and biological tests, not through expert interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the testing involves objective measurements based on established test methods and standards, not subjective expert assessment requiring adjudication.
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 is not applicable. The device is a physical protective gown, not an AI-powered diagnostic tool, so MRMC studies are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical garment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is established by international and national standards (e.g., ANSI/AAMI PB70, ISO 10993, ASTM, AATCC, 16 CFR Part 1610). The device's performance is measured against the specifications and requirements outlined in these standards.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of testing a physical medical device like a protective gown.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device.
§ 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.