(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 |
§ 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.