(219 days)
The GreenCross Surgical Masks are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situations where there is a risk of microorganism, body fluid, and particulate aerosol transfer.
GreenCross surgical masks, Type: Earloop or Tie-on, are pleated 3-ply mask. Inner and outer layers are made of 100% spun-bond polypropylene. Middle player is made of 100% meltblown polypropylene filter media. Ear-loops are made of soft latex free elastic loops. All of the materials used in the construction of the GreenCross surgical masks are being used in currently marketed devices, except the nose piece used plastic wire instead of aluminum wire.
K123787: GreenCross Surgical Mask Acceptance Criteria and Performance Study Analysis
This submission describes the non-clinical performance testing of the GreenCross Surgical Mask to establish substantial equivalence to a predicate device (K101000).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implicitly set by achieving comparable performance to the predicate device, or by meeting the "relevant requirements in the test standards." The reported device performance is directly compared to the predicate device's performance.
| Test | Acceptance Criteria (Implicit) | GreenCross Surgical Mask Performance | Predicate Device (K101000) Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Comparable to predicate; meets relevant standard requirements | 29 out of 32 pass at 120 mm Hg | 31 out of 32 pass |
| Particle Filtration Efficiency (ASTM F2299) | Comparable to predicate; meets relevant standard requirements | 99.1% | 99.8% |
| Bacteria Filtration Efficiency (ASTM F2101) | Comparable to predicate; meets relevant standard requirements | 99.8% | 99.9% |
| Differential Pressure (MIL-M-36945C) | Comparable to predicate; meets relevant standard requirements | 2.6-2.9 (mm Water/cm²) | 3.7-4.0 (mm Water/cm²) |
| Flammability (16CFR 1610) | Class 1 None Flammable | Class 1 None Flammable | Class 1 None Flammable |
| Biocompatibility (ISO 10993-5, -10) | Biocompatible | Biocompatible | Biocompatible |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual non-clinical test (e.g., number of masks tested for BFE, PFE). For the Fluid Resistance test (ASTM F1862), the result "29 out of 32 pass" indicates a sample size of 32 masks for that particular test.
The data provenance is from non-clinical tests conducted by the manufacturer, Jingzhou Haixin Green Cross Medical Products Co., Ltd. The country of origin for the testing is not explicitly stated, but the manufacturer is based in Wuhan City, Hubei, P. R, China. These are prospective test results generated specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable. The ground truth for this device is based on objective, standardized laboratory performance tests designed to measure physical properties and filtration capabilities. It does not involve human expert interpretation or subjective evaluation.
4. Adjudication Method for the Test Set
This section is not applicable. As the ground truth is established through standardized laboratory tests, there is no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not performed. This submission is for a surgical mask, and its performance is evaluated through non-clinical bench testing, not by comparing human reader performance.
6. Standalone (Algorithm Only) Performance
This section is not applicable. As this is a physical medical device (surgical mask), there is no algorithm or AI involved.
7. Type of Ground Truth Used
The ground truth used for evaluating the GreenCross Surgical Mask is based on objective, standardized laboratory performance testing as outlined by international and national standards (e.g., ASTM F2101, ASTM F2299, ASTM F1862, MIL-M-36945C, 16CFR 1610, ISO 10993). These standards define specific methodologies and criteria for measuring the performance attributes of surgical masks.
8. Sample Size for the Training Set
This section is not applicable. This is a physical device, not an AI/ML algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable. There is no training set for a physical surgical mask.
§ 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.