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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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(264 days)
LAITEST Medical Face Mask
The LAITEST MEDICAL FACE MASK 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 is a single use, disposable device(s), provided non-sterile.
LAITEST Surgical Face Mask are made of 3-layer non-woven material. The masks have a Bacterial Filtration Efficiency (BFE) and Particle Filtration Efficiency (PFE) Standards of 98%, and Virus Filtration Efficiency (VFE) Standards of 99%, which can effectively protect against sub-micron particles, fine dust, biological agents (bacteria, or viruses), and fluid splashes. The masks have ear loops and nose band which can provide a comfort wear for users.
The provided document is a 510(k) Premarket Notification for a surgical face mask (LAITEST Surgical Face Mask, K214035). This type of document focuses on demonstrating substantial equivalence to a previously cleared device, primarily through bench testing for safety and performance, rather than a clinical study involving human patients or complex AI algorithms.
Therefore, the requested information (sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, detailed ground truth establishment for AI, etc.) is not applicable to this submission, as it does not describe an AI medical device or a clinical study in the typical sense.
However, I can extract the acceptance criteria and performance data for the device based on the non-clinical (bench) tests performed.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance
| Item | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Determine synthetic blood penetration resistance | ≥29 of 32 pass at 120 mmHg | Pass (≥29 of 32 pass at 120 mmHg) |
| Particulate Filtration Efficiency (ASTM F2299) | Determine the bacterial filtration efficiency | > 98% | Pass (≥ 98%) |
| Bacterial Filtration Efficiency (ASTM F2101) | Determine submicron particulate filtration efficiency | > 98% | Pass (≥ 98%) |
| Differential Pressure (Delta P) (EN 14683) | Determine breathing resistance or differential pressure |
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(22 days)
Perfetta Moderate Medical Face Mask
Perfetta Moderate 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. This surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is single use, disposable device, provided non-sterile.
The subject device is three-layers, flat-pleated mask constructed of nonwoven polypropylene materials, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene. The subject device is provided with ear loops. Ear loops is made of 80% polyester 20% spandex, not made with natural rubber latex. A zinc wire nose piece with polypropylene coating is placed within the binding for comfort and individualized fit, allow the user to fit the facemask around their nose. The subject device is provided in blue color. The blue colorant is made of polypropylene master batch. This subject device is provided with size 17.5 cm ± 0.5 cm. The subject device is single-use, disposable device, provided non-sterile.
The provided text is related to the FDA 510(k) premarket notification for a medical face mask, not an AI/ML medical device. Therefore, a direct response to your detailed questions regarding acceptance criteria, study design for AI/ML devices, and ground truth establishment is not applicable. The information describes the performance testing of a physical product (medical face mask) against established industry standards.
However, I can extract the acceptance criteria and the device's performance based on the provided document as it pertains to the Perfetta Moderate Medical Face Mask.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | ≥29 out of 32 passed in 120 mmHg (Level 2) | ≥29 out of 32 passed in 120 mmHg (Level 2) | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥98% at 0.1µm | ≥98% at 0.1µm | Pass |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥98% | ≥98% | Pass |
| Differential Pressure (Delta P) |
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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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(57 days)
Medical Face Mask (M001)
The Medical Face Mask is intended to be worn to protect both the patient and healthcare persomel 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 Medical Face Mask (Model: M001) is available in white, blue and black colors, 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 is manufactured with three layers, the inner and outer layers are made of spun-bond 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 user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the 510(k) premarket notification for a Medical Face Mask (Model: M001). This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K211631) through non-clinical performance testing and biocompatibility assessments, rather than AI/ML algorithm performance.
Therefore, many of the requested criteria related to AI/ML device performance (like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample size for training sets, etc.) are not applicable to this submission, as it pertains to a physical medical device (face mask) and not an AI-powered diagnostic or assistive technology.
Here's the information that can be extracted and a clear indication of what is not applicable:
1. A table of acceptance criteria and the reported device performance
| Item | Purpose (Test) | 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. | Level 2: 29 out of 32 pass at 120 mmHg | ||
| Level 3: 29 out of 32 pass at 160 mmHg | Level 2: 32 out of 32 per lot pass at 120 mmHg for 3 non-consecutive lots tested | |||
| Level 3: 32 out of 32 per lot pass at 160 mmHg for 3 non-consecutive lots tested | 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% | Level 2: Average Result - 99.2% (3 non-consecutive lots tested, sample size 32/lot) | |
| Level 3: Average Result - 99.4% (3 non-consecutive lots tested, sample size 32/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% | Level 2: Average Result - 99.2% (3 non-consecutive lots tested, sample size 32/lot) | |
| Level 3: Average Result - 99.4% (3 non-consecutive lots tested, sample size 32/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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(57 days)
Medical Face Mask
The 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 a single use, disposable device(s), provided non-sterile.
The Proposed Device Medical Face Mask (Model: M001, M2002, M3001, M3002) are available in blue and black colors, 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(s) submitted meet both the performance requirements of level 2 and 3 specified in ASTM F2100-19. Level 2 blue mask is model number M2001; Level 2 black mask is model number M2002; Level 3 blue mask is model number M3001; Level 3 black mask is model number M3002; The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond 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 user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document is a 510(k) Summary for a Medical Face Mask (K221272). It details non-clinical tests to demonstrate substantial equivalence to a predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information (like effect size of AI assistance, expert qualifications, or adjudication methods for ground truth) is not applicable or cannot be extracted from this particular document.
Here's the available information based on the document:
1. A table of acceptance criteria and the reported device performance:
| Item | Acceptance Criteria | Reported Device Performance (Average Result) | Result |
|---|---|---|---|
| Fluid Resistance Performance | 29 out of 32 pass at 120 mmHg for Level 2 | Level 2: 32 out of 32 per lot pass at 120 mmHg (3 non-consecutive lots tested) | PASS |
| (ASTM F1862) | 29 out of 32 pass at 160 mmHg for Level 3 | Level 3: 32 out of 32 per lot pass at 160 mmHg (3 non-consecutive lots tested) | PASS |
| Particulate Filtration Efficiency | ≥ 98% | Level 2: 99.2% (3 non-consecutive lots tested) | PASS |
| (ASTM F2299) | Level 3: 99.5% (3 non-consecutive lots tested) | PASS | |
| Bacterial Filtration Efficiency | ≥ 98% | Level 2: 99.3% (3 non-consecutive lots tested) | PASS |
| (ASTM F2101) | Level 3: 99.3% (3 non-consecutive lots tested) | PASS | |
| 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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(122 days)
Medical Face Mask
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