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510(k) Data Aggregation
(60 days)
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. The medical surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The proposed surgical masks are blue color, three-layer, flat-pleaded masks with nose piece, ear loops or ties, which are composed of inner layer, middle layer and outer layer, with or without anti-fog foam strips and eye shield. The outer layers contains blue colorant and the inner layer contains white colorant, which are made of polypropylene.
Below are the configuration of each model.
GFM 96 - three-layer, flat-pleated with ear loops
GFM 91 - three-layer, flat-pleated with ear loops and anti-fog foam strip attached to nose clip
GFM 90 - three-layer, flat-pleated with ear loops, anti-fog foam strip attached to nose clip and eye shield
GFM 88 - three-layer, flat-pleated with ties
GFM 81 - three-layer, flat-pleated with ties and anti-fog foam strip attached to nose clip
GFM 80 - three-layer, flat-pleated with ties, anti-fog foam strip attached to nose clip and eye shield
The inner layer and outer layer of the mask are made of spunbond polypropylene, the middle layer is made of melt-blown polypropylene. The ear loops or ties of the subject mask are held in place over the users' mouth and nose by two ear loops or ties welded to the face mask. The ear loop is made with polyester and spandex, while the ties are made of spunbond polypropylene. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of PP and metal.
The masks may also contain an eye shield made from a polyethylene terephthalate film (PET) with foam strip. The eye shield is adhered to the top edge of the mask to cover the upper part of the eye to prevent potential exposure to blood and body fluids.
The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
The masks are designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
This document is a 510(k) Premarket Notification for a Surgical Mask, specifically models GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, and GFM 80, manufactured by Jingzhou Haixin Green Cross Medical Products Co., Ltd.
The purpose of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (K210147). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance standards and non-clinical testing conducted to show the device meets specific requirements for surgical masks and is equivalent to the predicate.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria for Level 3 Barrier | Reported Device Performance |
|---|---|---|---|
| Bacterial Filtration Efficiency (ASTM F2101) | Measure bacterial filtration efficiency | ≥98% | Passed (Lot 1: ≥98%, Lot 2: ≥98%, Lot 3: ≥98%) |
| Differential Pressure (mmH2O/cm²) (EN 14683:2019 Annex C) | Determine breathability of the mask |
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(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.
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