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510(k) Data Aggregation
(78 days)
Disposable Medical Face Mask (M643BE)
The Disposable Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical Face 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 Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner (3rd layer) and outer (1st layers are made of spun-bond polypropylene, the middle (2nd layer) is made of melt blown polypropylene. The nose piece is made of Iron core coated with polypropylene, ear loop is made of Nylon and Spandex.
Each mask contains ear loops to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex.
The Disposable Medical Face Masks are sold and are intended to be single use, disposable devices.
The mask is designed and manufactured in accordance with ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks.
This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask (M643BE). It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Test Methodology | Purpose | Acceptance Criteria (for Level 3 Barrier, assumed to be the target for this device given the predicate and tests) | Reported Device Performance (3 non-consecutive lots tested, using a sample size of 32/lot) |
|---|---|---|---|
| Bacterial Filtration Efficiency (ASTM F2101) | Measure bacterial filtration efficiency | ≥95% | Passed: |
| Lot 0923: ≥95% | |||
| Lot 1023: ≥95% | |||
| Lot 1123: ≥95% | |||
| Differential Pressure (mmH2O/cm²) (EN 14683:2019 Annex C) | Determine breathability of the mask |
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(67 days)
Disposable Medical Face Mask
The Disposable Medical Face Mask is intended to be worn to protect 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 is a single use, disposable device(s), provided non-sterile.
Disposable Medical Face Mask is a blue flat-pleated mask, which is worn in the way of earrings and has a nose clip design to fit the mask around the nose. This product is composed of a mask body (three-layer structure: two layers of polypropylene adhesive nonwoven fabric with a layer of polypropylene melt-blown nonwoven fabric in the middle), a nose clip (made of polyethylene) and ear loops (made of polyester + spandex). The nose clip is located in the middle layer of the mask. Ear loops, string-like material, are attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the acceptance criteria and the results of a study for a Disposable Medical Face Mask (K223055) to demonstrate its substantial equivalence to a predicate device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria | Proposed Device Performance (Reported Result) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 160 mmHg for Level 3 | 32 out of 32 pass at 160 mmHg (across 3 non-consecutive lots) | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Lot1: 99.39%, Lot2: 99.54%, Lot3: 99.37% (across 3 non-consecutive lots) | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Lot1: 99.01%, Lot2: 98.94%, Lot3: 99.06% (across 3 non-consecutive lots) | PASS |
| Differential Pressure (EN 14683 Annex C) |
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(58 days)
Disposable Medical Face Mask (DF3-001)
The Disposable Medical Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical For use in infection control practices to reduce the potential exposure to blood and body fluids.This is a single use, disposable device(s), provided non-sterile.
The Proposed device(s) are blue color, and pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The 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 Nylon and Spandex. 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 ,metal wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the acceptance criteria and the study conducted for a Disposable Medical Face Mask (DF3-001) to verify its performance and safety.
1. Table of acceptance criteria and the reported device performance:
| Item | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance 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 for level 3 | Lot1, Lot2, Lot3: 32 out of 32 pass at 160 mmHg (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS |
| Particulate Filtration Efficiency ASTM F2299 | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | ≥ 98% | Lot1: 99.35% | |
| Lot2: 99.46% | ||||
| Lot3: 98.69% (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS | |||
| 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% | Lot1: 99.88% | |
| Lot2: 99.87% | ||||
| Lot3: 99.88% (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS | |||
| 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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(88 days)
Disposable Medical Face Mask (ear loop)
The Disposable Medical Face 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 intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of Galvanized iron wire coated by PE, and the ear loop is made of polyester and spandex.
The disposable medical face masks are sold non-sterile and are intended to be single use, disposable devices.
This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask. It focuses on demonstrating that the proposed device is substantially equivalent to a legally marketed predicate device (K210433) by providing non-clinical test data.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|
| Fluid Resistance: 29 out of 32 pass at 160 mmHg | Pass: 32 out of 32 pass at 160 mmHg, 3 lots |
| Particulate Filtration Efficiency: $\ge$ 98% | Pass: Average 99.36% |
| Bacterial Filtration Efficiency: $\ge$ 98% | Pass: Average 99.40% |
| Differential Pressure (Delta P): |
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(63 days)
Disposable Medical Face Mask
The Disposable Medical Face Mask is 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 is a single use, disposable device(s), provided non-sterile.
The Disposable medical face mask is designed for single-use and should be disposed of properly after one wear. The Disposable medical face mask is divided into three layers, the inner and outer layers of the mask are made of Spunbond polypropylene, and the middle layer is made of Meltblown polypropylene. The mask contains ear loops or ear straps to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of PP non-woven cloth,the nose clip is made of Metal strip covered with PP covering. This is a single use, disposable device(s), provided non-sterile.
The provided document is a 510(k) premarket notification for a Disposable Medical Face Mask, not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove the device meets those criteria, specifically concerning AI/ML performance metrics, multi-reader multi-case studies, effect size of human readers improving with AI, standalone algorithm performance, and ground truth establishment/training sets, are not applicable.
However, I can extract the acceptance criteria and reported device performance for this medical face mask from the document:
1. A table of acceptance criteria and the reported device performance:
| Performance Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Discussion |
|---|---|---|---|
| Particulate Filtration Efficiency | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 99.68%, Lot 2: 99.56%, Lot 3: 99.81% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 99.926%, Lot 2: 99.93%, Lot 3: 99.936% | Similar (Subject device performance meets or exceeds predicate) |
| Bacterial Filtration Efficiency (BFE) | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 99.9%, Lot 2: 99.9%, Lot 3: 99.9% | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: ≥99%, Lot 2: ≥99%, Lot 3: ≥99% | Similar (Subject device performance meets criteria, although specific values for predicate are higher than the "≥99%" reported for the subject) |
| Differential Pressure | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: 3.8 mm H2O/cm², Lot 2: 3.6 mm H2O/cm², Lot 3: 3.7 mm H2O/cm² | 3 non-consecutive lots tested, using a sample size of 32/lot. Lot 1: |
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(96 days)
Disposable Medical Face Mask
The Disposable Medical Face Mask is 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 is a single use, disposable device(s), provided non-sterile.
Disposable Medical Face Mask is composed of Nylon & Spandex Ear loops, High Density Polyethylene nose clip, Inner layer Non-woven fabric, Middle Melt-blown Non-woven fabric and outer Non-woven fabric. The melt-blown material acts as the filter that stops microbes from entering or exiting the mask. Disposable Medical Face Mask feature pleats. Three pleats are used to expand the mask such that it covers the area from the nose to the chin. The type is ear loop, where a string-like material is attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) premarket notification for a Disposable Medical Face Mask. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI-powered medical device. Therefore, most of the requested information about an AI-powered device, such as MRMC studies, training set details, or expert ground truth establishment, is not applicable to this document.
However, I can extract the acceptance criteria and performance data for the physical properties of the face mask as tested.
Here's the relevant information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Purpose | Proposed Device (Reported Performance) | Acceptance Criteria | Result |
|---|---|---|---|---|
| Fluid Resistance ASTM F1862 | Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure | 32 out of 32 pass at 160 mmHg (across 3 lots) | 29 out of 32 pass at 160 mmHg for level 3 | PASS |
| Particulate Filtration Efficiency ASTM F2299 | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | Lot1: 98.9%, Lot2: 99.3%, Lot3: 99.5 % | ≥ 98% | PASS |
| 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 | Lot1: 99.88%, Lot2: 99.95%, Lot3: 99.97% | ≥ 98% | PASS |
| 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 | Lot1: 3.3 H2O/cm², Lot2: 3.4 H2O/cm², Lot3: 3.3 H₂O/cm² |
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(216 days)
Disposable Medical Face Mask
The disposable medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The disposable medical face mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric.The middle layer is made of melt blown polypropylene filter.only the outer layers' color is blue (colorant: Pigment Blue 15:3/Model:147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the disposable medical face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the disposable medical face mask is in the middle layer of disposable medical face mask to allow the user to fit the disposable medical face mask around their noses, which is made of malleable aluminum wire. The dimensions of each disposable medical face mask are length 175±10 mm and width 95±10 mm, The dimensions of nose piece is length 120±10 mm, and the ear loop is length 180±10 mm.
The mask model TP-001 meets both level 2 & level 3 performance requirements in ASTM F2100.The disposable medical face mask are sold non-sterile and are intended to be single use,disposable devices.
This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask, seeking to demonstrate substantial equivalence to a predicate device. It addresses the physical and filtration performance of the mask, rather than the performance of an AI/ML-driven medical device. Therefore, many of the requested criteria relating to AI/ML device performance, such as sample size for test/training sets, expert ground truth establishment, MRMC studies, and human-in-the-loop performance, are not applicable to this document.
However, I can extract and present the information available regarding the acceptance criteria and the study that proves the device meets those criteria for this medical face mask.
Device: Disposable Medical Face Mask (Model TP-001)
Product Code: FXX
Regulation Number: 21 CFR 878.4040
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
The device model TP-001 is stated to meet both Level 2 and Level 3 performance requirements in ASTM F2100. The table below combines the acceptance criteria and the observed performance for both levels as presented in the document.
| Test Item (Performance Level 2/Level 3) | Acceptance Criteria (Level 2) | Acceptance Criteria (Level 3) | Reported Device Performance (Model TP-001 - across 3 lots) | Verdict |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-19) | BFE ≥ 98% | BFE ≥ 98% | Lot A: 99.9%, Lot B: 99.9%, Lot C: 99.9% | Pass |
| Differential Pressure (Delta-P) (EN 14683:2019, Annex C) | Delta-P |
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(416 days)
Disposable Medical Face Mask
The Disposable Medical Face Mask is 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 is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Face Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold nonsterile and are intended to be single use, disposable devices.
The provided document describes the acceptance criteria and the study that proves the device (Disposable Medical Face Mask, K202676) meets these criteria. All information is extracted directly from the provided text.
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Resistance penetration synthetic blood (Test Method F1862) | To Determine synthetic blood penetration resistance | 29 Out of 32 pass at 120 mmHg | Lot 1: 31 out of 32 pass at 120mmHg |
| Lot 2: 31 out of 32 pass at 120mmHg | |||
| Lot 3: 32 pass at 120mmHg | |||
| Pass | |||
| Particulate Filtration Efficiency (ASTM F2299) | Determine particulate filtration efficiency | ≥ 98% | Lot 1: average 99.23% |
| Lot 2: average 99.29% | |||
| Lot 3: average 99.29% | |||
| Pass | |||
| Bacterial Filtration Efficiency (ASTM F2101) | Determine the bacterial filtration efficiency | ≥ 98% | Lot 1: average 99.75% |
| Lot 2: average 99.79% | |||
| Lot 3: average 99.75% | |||
| Pass | |||
| Differential Pressure (Delta - P) (EN 14683:2019, Annex C) | Determine breathing resistance or differential pressure |
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(232 days)
Wilson Tech Disposable Medical Face Mask
Wilson Tech Disposable Medical Face Mask is 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. Wilson Tech Disposable Medical Face Mask is single use, disposable device, provided non-sterile.
Wilson Tech Disposable Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece made of galvanized iron wire coated with polyethylene to provide a firm fit over the nose.
The provided document is a 510(k) premarket notification for a medical device, specifically the Wilson Tech Disposable Medical Face Mask. It details the device's characteristics and its comparison to a predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document includes a detailed table comparing the subject device (Wilson Tech Disposable Medical Face Mask) with the primary predicate device (DemeMASK Surgical Mask - K201479). The key acceptance criteria are based on surgical mask performance standards, primarily ASTM F2100 Level 3.
| Test Methodology | Purpose of the test | Acceptance criteria | Test Results (Wilson Tech Disposable Medical Face Mask) |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | Performed in accordance with ASTM F2101 to determine the bacterial filtration efficiency using a biological aerosol of Staphylococcus aureus. | Level 3: ≥98% | 32/32 Passed at ≥99.3% |
| Particulate Filtration Efficiency (PFE) | Performed in accordance with ASTM F2299 to determine the particle filtration efficiency using latex spheres. | Level 3: ≥98% | 32/32 Passed at ≥99.28% |
| Differential Pressure (delta-P) | Performed in accordance with MIL-M-36954C. Measures the breathability of the mask. |
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(339 days)
Disposable medical face mask
The Disposable medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.
The disposable medical face mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document describes the acceptance criteria and the study conducted for a Disposable Medical Face Mask (K202745), not an AI-powered medical device. Therefore, many of the requested fields related to AI/MRMC studies, number of experts, and ground truth establishment are not applicable.
However, I can extract the information relevant to the performance testing of the medical face mask as described in the document.
Here's a breakdown of the acceptance criteria and study results for the Disposable Medical Face Mask:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Purpose | Acceptance Criteria (Level 2, ASTM F2100-19) | Reported Device Performance |
|---|---|---|---|
| Bacterial filtration efficiency (BFE) (%) | To evaluate Bacterial filtration efficiency (BFE) (%) | ≥98 | Pass |
| Differential pressure (mmH2O/cm²) | To evaluate Differential pressure (mmH2O/cm²) |
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