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510(k) Data Aggregation
(211 days)
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.
The proposed devices are Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim. The gloves are available in two colors: blue and white. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document is a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White)" and "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue)". This document is for a medical device (gloves) and not for an AI/ML-driven medical device or software. Therefore, the questions related to AI/ML device testing (such as sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to the content provided.
However, I can extract the acceptance criteria and the study results for the glove's performance as presented in the document, especially regarding its resistance to chemotherapy drugs and other physical properties.
Here's the information based on the provided document, addressing the relevant points and indicating "N/A" for those that do not apply to this type of device:
Device Description: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the gloves are primarily based on ASTM standards and comparisons to a predicate device (K141982). The key performance characteristic tested for this submission is the "Breakthrough Detection Time" for various chemotherapy drugs, which reflects the glove's ability to protect against exposure.
Acceptance Criteria & Device Performance Comparison (Current Device vs. Standards/Predicate)
| Characteristic | Standard / Predicate Acceptance Criteria (Predicate 1: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves Tested for Use with Chemotherapy Drugs, K141982) | Current Device Performance (White Gloves) | Current Device Performance (Blue Gloves) |
|---|---|---|---|
| Physical Properties | |||
| Length | Min 240mm (ASTM D6319-10(2015)) | Min 240mm | Min 240mm |
| Width (medium glove) | Min 85 mm (ASTM D6319-10(2015)) | Min 85 mm | Min 85 mm |
| Tensile Strength (before aging) | Meets min 14Mpa (ASTM D6319-10(2015)) | Meets min 14Mpa | Meets min 14Mpa |
| Tensile Strength (after aging) | Meets min 14Mpa (ASTM D6319-10(2015)) | Meets min 14Mpa | Meets min 14Mpa |
| Elongation (before aging) | Meets min 500% (ASTM D6319-10(2015)) | Meets min 500% | Meets min 500% |
| Elongation (after aging) | Meets min 400% (ASTM D6319-10(2015)) | Meets min 400% | Meets min 400% |
| Thickness – Finger | Meets min 0.05 mm (ASTM D6319-10(2015)) | Meets min 0.05 mm | Meets min 0.05 mm |
| Thickness – Palm | Meets min 0.05 mm (ASTM D6319-10(2015)) | Meets min 0.05 mm | Meets min 0.05 mm |
| Powder Content | ≤ 2 mg/glove (ASTM D6124-06(2011)) | Meets | Meets |
| Watertight (1000ml) | Passes (21 CFR 800.20, ASTM D5151) | Passes | Passes |
| Biocompatibility | |||
| Primary Skin Irritation | Non-irritating (ISO 10993-10:2010) | Non-irritating | Non-irritating |
| Dermal Sensitization | Non-sensitizing (ISO 10993-10:2010) | Non-sensitizing | Non-sensitizing |
| Chemotherapy Drug Permeation Test (ASTM D6978-05) | Predicate Breakthrough Detection Time (min) | Current Device White Gloves Breakthrough Detection Time (min) | Current Device Blue Gloves Breakthrough Detection Time (min) |
| Cisplatin, 1.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Cyclophosphamide, 20.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Doxorubicin HCl, 2.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Etoposide (Toposar), 20.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Fluorouracil, 50.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Ifosfamide, 50.0 mg/ml | >240 (Predicate only, current device not tested for this) | N/A | N/A |
| Mitoxantrone, 2.0 mg/ml | >240 (Predicate only, current device not tested for this) | N/A | N/A |
| Vincristine Sulfate, 1.0 mg/ml | >240 (Predicate only, current device not tested for this) | N/A | N/A |
| Carmustine (BCNU) 3.3mg/ml | 15.0 | 24.0 | 18.2 |
| Thiotepa 10.0 mg/ml | 2.0 | 54.9 | 57.3 |
| Warning Statement | Identical warning regarding low permeation times for Carmustine and Thiotepa. | Identical warning, updated times based on testing. | Identical warning, updated times based on testing. |
Note: For Carmustine and Thiotepa, while the breakthrough times might seem low, the predicate also had low times (Thiotepa as low as 2 minutes). The current device shows improved or comparable performance for these challenging drugs, and the critical acceptance criterion is that the warning statement regarding these drugs' properties is present and updated to reflect the tested performance.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for each specific test (e.g., number of gloves tested for chemotherapy permeation or physical properties). However, the testing would have been conducted in accordance with the cited ASTM standards, which define the necessary sample sizes and testing methodologies for such evaluations.
- Data Provenance: The device is manufactured by Comfort Rubber Gloves Industries Sdn Bhd in Matang, Perak, Malaysia. The testing data would originate from laboratory tests conducted on the manufactured gloves.
- Retrospective or Prospective: These tests are prospective (pre-market) evaluations conducted specifically to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical device where "ground truth" is established through standardized laboratory testing protocols (e.g., ASTM D6978 for chemotherapy drug permeation, ASTM D6319 for physical properties, ISO 10993 for biocompatibility) that yield objective measurements, rather than expert interpretation of complex data (like medical images).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not applicable for physical device performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. Not applicable for this physical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. Not applicable for this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements derived from standardized laboratory test methods (e.g., ASTM standards for glove performance and ISO standards for biocompatibility). For instance, the breakthrough detection time for chemotherapy drugs is a direct measurement based on chemical analysis, not expert consensus or clinical outcomes.
8. The sample size for the training set
N/A. This document pertains to a physical medical device (gloves), not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
N/A. This document pertains to a physical medical device (gloves), not an AI/ML system.
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(134 days)
A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hands or finger(s) to prevent contamination between patient and examiner.
POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
This document is a 510(k) clearance letter from the FDA for Powder-Free Nitrile (Black) Examination Gloves. It does not contain the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device or AI system.
The text explains that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It does not include any performance data or study details typically found in a summary of safety and effectiveness.
Therefore, I cannot fulfill your request for the specific information.
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(112 days)
A powder-free patient examination glove is a disposable device made of natural rubber latex material that is intended for medical purposes to be worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
POWDER FREE LATEX (PINK) EXAMINATION GLOVES. A powder-free patient examination glove is a disposable device made of natural rubber latex material.
The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powder Free Latex (Pink) Examination Gloves." It confirms the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.
This document does not contain information about acceptance criteria or a study that proves the device meets those criteria for an AI/ML medical device.
The document pertains to the regulatory clearance of a physical medical device (examination gloves), not a software or AI-based device. Therefore, it does not include details such as:
- A table of acceptance criteria and reported device performance (for AI/ML metrics like sensitivity, specificity, AUC).
- Sample sizes for test sets, data provenance, or numbers/qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or standalone algorithm performance.
- Types of ground truth for AI/ML models.
- Sample sizes for training sets or how their ground truth was established.
The "Indications for Use" section simply describes the intended use of the physical gloves to prevent contamination.
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(46 days)
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(53 days)
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(150 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Comfort Powderfree Latex Examination Glove with Latex ("Powder-free") 80LYY Protein Content Labeling Claim (50 micrograms or less)
The provided document is a 510(k) premarket notification letter from the FDA regarding "Comfort Powder-Free Latex Examination Gloves." This document grants substantial equivalence to a medical device, which is a regulatory approval, not a scientific study describing acceptance criteria and device performance based on a study.
Therefore, the document does not contain any of the requested information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance), or training set information. The document solely focuses on regulatory approval based on substantial equivalence to a predicate device.
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