(289 days)
Surgical gown is 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 AE series surgical gowns met the requirements for Level 2 classification.
Surgical gown is 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 AG series surgical gowns met the requirements for Level 3 classification.
The Surgical Gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relabler for further packaging and Ethylene Oxide (EO) sterilization.
The subject device includes six models, which are provided in Table 1 Model List. The six models have the same product size, the only difference is whether the surgical gown has an inside reinforcement and material of the reinforcement. AG1001 and AE1001 don't have the reinforcement. AG2001 and AE2001 have an inside trapezoidal fabric-reinforcement on the chest and two sleeves of the gown. AG3001 and AE3001 have an inside rectangular poly-reinforcement on the chest and two sleeves of the gown.
The document is a 510(k) summary for GMAX Industries, Inc.'s Surgical Gown (AE and AG series). It describes the device, its intended use, and demonstrates substantial equivalence to predicate devices based on non-clinical testing.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparison of the subject device (GMAX Surgical Gown) with two predicate devices (Medline Eclipse™ Surgical Gown and Disposable Surgical Gowns by Weihai Hongyu Nonwoven Fabric Products Co., Ltd.). The table highlights several physical and mechanical specifications as acceptance criteria and reports the subject device's performance against these criteria, or states "Not known" for predicate devices.
| Item | Acceptance Criteria (Subject Device Performance) | Predicate Device 1 Performance | Predicate Device 2 Performance |
|---|---|---|---|
| Barrier Protection Level (AAMI PB70) | Level 2 (AE series) / Level 3 (AG series) | Level 2 | Level 3 |
| Tearing Strength | >30N | Not known | Not known |
| Fire Protection | Class I | Not known | Class I |
| Lint | $Log_{10} 30 ft3/min/ft2 | Not known | Not known |
| Tensile Strength | ≥20N | Not known | ≥20N |
| Durability | Disposable | Disposable | Disposable |
| Biocompatibility | Non-toxic, non-irritating, non-sensitizing | Non-toxic, non-irritating, non-sensitizing | Non-toxic, non-irritating, non-sensitizing |
Note on Acceptance Criteria: The document primarily uses the predicate devices' characteristics and recognized standards (like AAMI PB70) as benchmarks for "acceptance criteria." For some parameters, the subject device's specific performance values are presented as meeting these underlying standards or being "large enough for safety using" even when predicate values are unknown.
2. Sample Sizes and Data Provenance
The document explicitly states: "No clinical study is included in this submission."
Therefore, information regarding sample size for test sets, data provenance (e.g., country of origin, retrospective/prospective) for a clinical study is not applicable as no clinical study was conducted. The testing was non-clinical.
3. Number of Experts and Qualifications
This information is not applicable. Since no clinical study was performed and no human performance evaluation (e.g., diagnostic accuracy) was part of this submission, there was no need for experts to establish ground truth for a test set.
4. Adjudication Method
This information is not applicable for the same reasons as above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. No MRMC study was conducted. The submission is for a medical device (surgical gown) and focuses on physical and biological testing, not on comparative effectiveness for diagnosis or treatment involving human readers.
6. Standalone (Algorithm Only) Performance
This information is not applicable. The device is a surgical gown, not an algorithm or AI system.
7. Type of Ground Truth Used
For the non-clinical tests, the "ground truth" or reference standards used are established test methods from recognized standards organizations. These include:
- AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes
- ASTM D737-04 (2016) Standards Test Method for Air Permeability of Textile Fabrics
- 16 CFR 1610: 2008 Standard for the Flammability of Clothing Textiles
- AATCC 127:2003 Water Resistance: Hydrostatic Pressure Test
- AATCC 42:2007 Water Resistance: Impact Penetration Test
- ISO 9073-10:2003 Textiles- Test Method for Nonwovens- Part 10: Lint and Other Particles Generation in the Dry State
- ASTM D1683-11 Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
- ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
- ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- 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
These standards define the methodologies and expected outcomes for each test.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product (surgical gown), not a software or AI 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 reasons as above.
§ 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.