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510(k) Data Aggregation
(199 days)
The Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is a nitrile patient examination glove. The design of proposed device addresses the standard specification requirements of ASTM D6319-19. The proposed device is non-sterile and powder free, with fern green, midnight black and sky blue three colors.
The document provided describes the acceptance criteria and the results of non-clinical performance testing for "Patient Examination Gloves" (nitrile gloves) in support of a 510(k) submission (K230777).
Here's an analysis of the provided information, focusing on the requested aspects.
1. A table of acceptance criteria and the reported device performance
Please note that for multiple colors of gloves (Fern Green, Blue Sky, Midnight Black), the results were consistently reported and are summarized below for brevity where they pass the criteria. Where specific values for each color are provided and vary, they are listed.
Acceptance Criteria and Reported Device Performance
| No. | Name of the Test Methodology | Standard | Acceptance Criteria | Reported Device Performance and Remarks | Pass/Fail |
|---|---|---|---|---|---|
| 1 | Tests For Skin Sensitization | ISO 10993-10:2021 | Skin Sensitization Test: Grades less than 1, otherwise sensitization. | Fern Green, Blue Sky, Midnight Black: No sensitization response was observed in control and treatment group animals. Classified as "non-sensitizer". | Pass |
| 2 | Tests For Skin Irritation | ISO 10993-23:2021 | Skin Irritation Test: Primary irritation index 0-0.4 (Negligible), 0.5-1.9 (Slight), 2-4.9 (Moderate), 5-8 (Severe). (Implied goal is negligible or slight irritation). | Fern Green, Blue Sky, Midnight Black: No abnormality detected in animals. Classified as "non-irritant". | Pass |
| 3 | In Vitro Cytotoxicity | ISO 10993-5:2009 | Cell viability reduced to <70% of the blank indicates cytotoxic potential. | Fern Green, Blue Sky, Midnight Black: Cell viability post treatment with 25%, 50%, and 100% test item extracts observed was less than 70% when compared to the vehicle control at all concentrations except 12.5%. Hence, the test item extract was considered to be cytotoxic. (However, the device passed Acute Systemic Toxicity). | Fail |
| 4 | Systemic Toxicity | ISO 10993-11:2017 | No adverse systemic reactions. | Fern Green, Blue Sky, Midnight Black: No animal deaths or loss in body weight. Did not reveal systemic toxicity. | Pass |
| 5 | Residual Powder on Medical Gloves | ASTM D6124-06 (2022) | Powder residue limit of 2.0 mg/glove. | Fern Green: 0.6 mg/glove. Blue Sky: 0.9 mg/glove. Midnight Black: 0.8 mg/glove. | Pass |
| 6 | Detection of Holes in Medical Gloves | ASTM D5151-2006 | Freedom from holes, AQL: 2.5 (ISO 2859). | Fern Green, Blue Sky, Midnight Black: 0 Glove leakage. | Pass |
| 7 | Physical dimensions (Length) | ASTM D6319-19 | S: Length ≥ 220 mm; M: Length ≥ 230 mm; L: Length ≥ 230 mm; XL: Length ≥ 230 mm. | Fern Green: S: 241 mm, M: 253 mm, L: 255 mm, XL: 257 mm. Blue Sky: S: 242 mm, M: 251 mm, L: 254 mm, XL: 254 mm. Midnight Black: S: 240 mm, M: 253 mm, L: 254 mm, XL: 253 mm. (All pass) | Pass |
| Physical dimensions (Width) | ASTM D6319-19 | S: 80 ± 10 mm; M: 95 ± 10 mm; L: 110 ± 10 mm; XL: 120 ± 10 mm. | Fern Green: S: 85 mm, M: 97 mm, L: 110 mm, XL: 118 mm. Blue Sky: S: 82 mm, M: 97 mm, L: 111 mm, XL: 118 mm. Midnight Black: S: 84 mm, M: 98 mm, L: 109 mm, XL: 119 mm. (All pass) | Pass | |
| Thickness (Finger) | ASTM D3767-03 | Finger ≥ 0.05 mm. | Fern Green: 0.11 mm. Blue Sky: 0.09 mm. Midnight Black: 0.10 mm. (All pass) | Pass | |
| Thickness (Palm) | ASTM D3767-03 | Palm ≥ 0.05 mm. | Fern Green: 0.06 mm. Blue Sky: 0.08 mm. Midnight Black: 0.07 mm. (All pass) | Pass | |
| 8 | Physical properties: Before aging (Tensile Strength) | ASTM D412-16 | Tensile strength ≥ 14MPa. | Fern Green: 17.23 MPa. Blue Sky: 17.17 MPa. Midnight Black: 17.25 MPa. (All pass) | Pass |
| Physical properties: Before aging (Ultimate Elongation) | ASTM D412-16 | Ultimate Elongation ≥ 500%. | Fern Green: 540%. Blue Sky: 539%. Midnight Black: 541%. (All pass) | Pass | |
| 9 | Physical properties: After Accelerated Aging (Tensile Strength) | ASTM D412-16 | Tensile strength ≥ 14MPa. | Fern Green: 16.30 MPa. Blue Sky: 16.32 MPa. Midnight Black: 16.23 MPa. (All pass) | Pass |
| 10 | Physical properties: After Accelerated Aging (Ultimate Elongation) | ASTM D412-16 | Ultimate Elongation ≥ 400%. | Fern Green: 450%. Blue Sky: 449%. Midnight Black: 452%. (All pass) | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document extensively lists the accepted criteria for various tests, but it does not explicitly state the sample sizes used for each specific test in the provided tables. For example, for "Detection of Holes", it simply states "0 Glove leakage" without indicating how many gloves were tested to achieve this. Similarly, for biocompatibility tests, it reports results (e.g., "No sensitization response") but not the number of animals or cells used.
The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text. The submission is from 3A Glove Sdn. Bhd. (Malaysia), with a designated correspondent in Shanghai, China, but this doesn't clarify where the tests themselves were conducted or the origin of the samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes non-clinical performance testing for medical devices (gloves), not a diagnostic device or AI system that requires expert interpretation for establishing ground truth. The tests are based on objective physical, chemical, and biological measures against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data where consensus among experts is needed.
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
This information is not applicable as the document is for a medical device (patient examination gloves) and not an AI-assisted diagnostic device. No comparative effectiveness study with human readers or AI assistance was conducted or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a patient examination glove, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to report.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance tests is based on established objective measurements and standardized test methods as defined by recognized international and national standards (ISO, ASTM). For example:
- Biocompatibility: Adherence to biological response criteria in animal models (ISO 10993 series).
- Physical Properties: Measurement of dimensions, tensile strength, and elongation against specifications in ASTM standards (e.g., D6319, D412).
- Hole Detection: Compliance with acceptable quality levels (AQL) as per statistical sampling plans (ASTM D5151, ISO 2859).
- Powder Content: Direct measurement against a defined limit (ASTM D6124).
The acceptance criteria themselves serve as the "ground truth" that the device must meet.
8. The sample size for the training set
This information is not applicable. The device is a physical product (nitrile gloves), not an artificial intelligence or machine learning system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8. No training set or associated ground truth establishment is relevant to the conformity testing of patient examination gloves.
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(185 days)
Chemotherapy Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. The proposed device is non-sterile, with fern green, midnight black and sky blue three colors.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large and with fern green, midnight black and sky blue three colors for options to each sizes.
The provided text describes the acceptance criteria and the study that proves Chemotherapy Gloves meets these criteria. The study specifically focuses on the physical properties of the gloves and their resistance to permeation by chemotherapy drugs.
Here’s a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Test | Reported Device Performance | Standard Met? |
|---|---|---|
| Physical Properties (per ASTM D6319) | ||
| Before Aging: Tensile Strength | ≥ 14 MPa | Yes |
| Before Aging: Ultimate Elongation | ≥ 500% | Yes |
| After Aging: Tensile Strength | ≥ 14 MPa | Yes |
| After Aging: Ultimate Elongation | ≥ 400% | Yes |
| Freedom from Holes (per ASTM D5151) | AQL=2.5 | Yes |
| Powder Content (per ASTM D6124) | Fern Green: 0.6 mg/glove; Midnight black: 1.1 mg/glove; Sky blue: 1.0 mg/glove (All are ≤ 2 mg/glove, which is the predicate device's performance, implying this is the criterion.) | Yes |
| Chemotherapy Drug Permeation (per ASTM D6978) | ||
| Carboplatin (10 mg/ml) | > 240 min | Yes |
| Carmustine (3.3 mg/ml) | Midnight black: 32.6 min; Sky blue: 24.5 min; Fern Green: 24.3 min | Yes (Reported) |
| Cisplatin (1.0 mg/ml) | > 240 min | Yes |
| Cyclophosphamide (20.0 mg/ml) | > 240 min | Yes |
| Dacarbazine (10 mg/ml) | > 240 min | Yes |
| Docetaxel (10 mg/ml) | > 240 min | Yes |
| Doxorubicin HCL (2.0 mg/ml) | > 240 min | Yes |
| Epirubicin HCI (2 mg/ml) | > 240 min | Yes |
| Etoposide (20 mg/ml) | > 240 min | Yes |
| Fluorouracil (50.0 mg/ml) | > 240 min | Yes |
| Gemcitabine (38 mg/ml) | > 240 min | Yes |
| Ifosfamice (50 mg/ml) | > 240 min | Yes |
| Irinotecan (20 mg/ml) | > 240 min | Yes |
| Methotrexate (25 mg/ml) | > 240 min | Yes |
| Mitomycin (0.5 mg/ml) | > 240 min | Yes |
| Mitoxantrone HCl (2 mg/ml) | > 240 min | Yes |
| Oxaliplatin (5 mg/ml) | > 240 min | Yes |
| Paclitaxel (6.0 mg/ml) | > 240 min | Yes |
| Thio Tepa (10.0 mg/ml) | Midnight black: 58.7 min; Sky blue: 77.3 min; Fern Green: 67.9 min | Yes (Reported) |
| Vincristine Sulfate (1 mg/ml) | > 240 min | Yes |
| Biocompatibility (per ISO 10993) | ||
| Irritation (ISO 10993-10) | Not an irritant | Yes |
| Skin Sensitization (ISO 10993-10) | Not a sensitizer | Yes |
| Cytotoxicity (ISO 10993-5) | Potentially cytotoxic (However, the submission states that acute systemic toxicity test results show the device is safe, implying the overall biological safety is acceptable.) | Yes (Mitigated/Accepted) |
| Acute Systemic Toxicity (ISO 10993-11) | Does not elicit acute systemic toxicity response in the model animal | Yes |
Note: For Carmustine and Thio Tepa, the reported breakthrough times are below 240 minutes, which is explicitly noted with a warning: "Please do not use with Carmustine and Thiotepa." This indicates that these specific drugs do not meet a >240 min criterion, but the performance is clearly reported, and the device is indicated to be used with other drugs, or with a warning for these specific drugs. Therefore, even with lower permeation times for these specific drugs, the device still "meets" acceptance criteria by explicitly disclosing the limitation and providing warnings.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for tensile strength or permeation). It mentions that "the proposed device was tested" for permeation, implying a test set was used.
The data provenance is not explicitly stated in terms of country of origin for the testing data or whether it was retrospective or prospective. However, the submitter, 3A Glove Sdn. Bhd., is located in Malaysia, and the submission correspondent, Shanghai Truthful Information Technology Co., Ltd., is in China. This suggests the testing may have been conducted in these regions or by contract labs associated with them. The testing is non-clinical performance testing (bench testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is Not Applicable as the device is a Chemotherapy Glove and the studies described are non-clinical (bench) performance and biocompatibility tests, not studies requiring expert interpretation of medical images or patient data. Ground truth in this context refers to established scientific or engineering methods as defined by the ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is Not Applicable for the same reason as point 3. The testing involves objective measurements based on specified standard test methods, not human interpretation that would require adjudication.
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
This section is Not Applicable. The device is a medical glove, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable. The device is a medical glove, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by recognized, standardized test methods from organizations like ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). These standards define specific procedures and criteria for evaluating physical properties (e.g., tensile strength, elongation), freedom from holes, powder content, and chemotherapy drug permeation. Biocompatibility is also assessed against ISO standards. Therefore, the ground truth is based on:
- Standardized Test Methods: Adherence to ASTM D6319, ASTM D6124, ASTM D5151, ASTM D6978, ISO 10993-10, ISO 10993-5, and ISO 10993-11.
- Objective Measurements: Quantitative data obtained through these standardized tests (e.g., MPa for tensile strength, percentage for elongation, mg/glove for powder content, minutes for breakthrough time, qualitative observations for irritation/sensitization/toxicity).
8. The sample size for the training set
This section is Not Applicable. The device is a physical product (a glove), not an artificial intelligence model that requires a training set.
9. How the ground truth for the training set was established
This section is Not Applicable for the same reason as point 8.
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