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510(k) Data Aggregation
(101 days)
Zhejiang Lanhine Medical Products LTD
The Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are 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 device (model: 15604F) is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed device (model: 15704F) is blue color, and Flat Pleated type mask, utilizing tie-on way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with three layers, the inner and outer layers are made of Non-woven Fabric(polypropylene), and the middle layer is made of Melton brown Fabric (Polypropylene). The 15604F model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polyurethane. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The 15704F model of proposed device, tie-on, is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of non-woven Fabric (Polypropylene). The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron.
The proposed devices are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the acceptance criteria and performance data for a Level 3 Fluid Resistant Procedure/Surgical Mask (models 15604F, 1570F). This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Result 1 (Model: 15604F) | Result 2 (Model: 15704F) |
|---|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure | 29 out of 32 pass at 160 mmHg | PASS (32 out of 32 pass at 160 mmH2O for 3 non-consecutive lots) | PASS (32 out of 32 pass at 160 mmH2O for 3 non-consecutive lots) |
| Particulate Filtration Efficiency (ASTM F2299) | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | ≥ 98% | PASS (Lot1: 99.4%, Lot2: 99.5%, Lot3: 99.4% for 3 non-consecutive lots) | PASS (Lot1: 99.74%, Lot2: 99.85%, Lot3: 99.85% for 3 non-consecutive lots) |
| Bacterial Filtration Efficiency (ASTM F2101) | Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism | ≥ 98% | PASS (Lot1: 99.4%, Lot2: 99.4%, Lot3: 99.4% for 3 non-consecutive lots) | PASS (Lot1: 99.7%, Lot2: 99.8%, Lot3: 99.7% for 3 non-consecutive lots) |
| Differential Pressure (Delta P) (EN 14683 Annex C) | Assess the performance of a mask for resistance to air movement through the materials of the face of the mask |
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(86 days)
Zhejiang Lanhine Medical Products LTD
The Fluid Resistant Procedure/Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The proposed device (model: 15603F) is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed device (model: 15703F) is blue color, and Flat Pleated type mask, utilizing tie-on way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with three layers, the inner and outer layers are made of Non-woven Fabric(polypropylene), and the middle layer is made of Melton brown Fabric (Polypropylene). The 15603F model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polyurethane. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The 15703F model of proposed device, tie-on, is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of non-woven Fabric (Polypropylene). The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The proposed devices are sold non-sterile and are intended to be single use, disposable device.
This appears to be a 510(k) summary for a medical device (Fluid Resistant Procedure/Surgical Mask), which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive comparative effectiveness study with human readers or clinical outcomes. Therefore, many of the requested points related to AI/human reader studies, expert ground truth, and training data will not be applicable.
However, based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria | Proposed Device (Model: 15603F) Performance | Proposed Device (Model: 15703F) Performance | Result (for both models) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg for level 2 | 3 non-consecutive lots tested, using a sample size of 32/lot. 32 out of 32 pass at 120 mmHg. | 3 non-consecutive lots tested, using a sample size of 32/lot. 32 out of 32 pass at 120 mmHg. | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.15%, Lot2: 99.22%, Lot3: 99.22%. | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.03%, Lot2: 99.10%, Lot3: 99.30%. | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.40%, Lot2: 99.50%, Lot3: 99.60%. | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.20%, Lot2: 99.30%, Lot3: 99.30%. | PASS |
| Differential Pressure (Delta P) (EN 14683 Annex C) |
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