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510(k) Data Aggregation
(24 days)
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a non-sterile disposable device intended for medical purposes that is worn on the exammer's hands or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes, and can be used with the device.
Cyclophosphamide (20.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fluorouracil (50.0 mg/ml) Paclitaxel (6.0 mg/ml) Cisplatin (1.0 mg/ml) Dacarbazine (10.0 mg/ml)
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 15 minutes ThioTEPA (10.0 mg/ml): 97 minutes
Warning: Not for Use with: Carmustine, ThioTEPA
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per D6978-05(2023). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only. NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) are offered in different sizes: S/M/L/XL.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Physical Dimensions | |||
| Length (S) | Physical Dimensions Test | $\ge$ 220 mm | $\ge$ 220 mm |
| Length (M/L/XL) | Physical Dimensions Test | $\ge$ 230 mm | $\ge$ 230 mm |
| Width (S) | Physical Dimensions Test | 80 $\pm$ 10 mm | 84-86/Pass |
| Width (M) | Physical Dimensions Test | 95 $\pm$ 10 mm | 96-102/Pass |
| Width (L) | Physical Dimensions Test | 110 $\pm$ 10 mm | 104-107/Pass |
| Width (XL) | Physical Dimensions Test | 120 $\pm$ 10 mm | 114-116/Pass |
| Thickness (Palm) | Physical Dimensions Test | $\ge$ 0.05 mm | 0.07-0.08/Pass |
| Thickness (Finger) | Physical Dimensions Test | $\ge$ 0.05 mm | 0.09-0.11/Pass |
| Watertightness | Detection of Holes | AQL 2.5 | 0/125/Pass |
| Powder Content | Powder Content | $\le$ 2.0 mg per glove | 0.16-0.19 mg/Pass |
| Physical Properties | |||
| Tensile Strength (before aging) | Physical Properties | $\ge$ 14 Mpa | 20-24 Mpa |
| Tensile Strength (after aging) | Physical Properties | $\ge$ 14 Mpa | 15-23 Mpa |
| Ultimate Elongation (before aging) | Physical Properties | $\ge$ 500 % | 501-598 % |
| Ultimate Elongation (after aging) | Physical Properties | $\ge$ 400 % | 471-561 % |
| Chemotherapy Permeation | Chemotherapy drug claim | No breakthrough up to 240 minutes for specified drugs | >240 minutes for Cyclophosphamide, Doxorubicin HCl, Etoposide, Fluorouracil, Paclitaxel, Cisplatin, Dacarbazine |
| Low permeation times for specified drugs | Carmustine: 15 minutes, ThioTEPA: 97 minutes | ||
| Cytotoxicity | Cytotoxicity | Non-cytotoxic | Device extract is cytotoxic (met acceptance criteria by identifying the result) |
| Irritation | Irritation | Non-irritating | Non-irritant / Pass |
| Sensitization | Sensitization | Non-sensitizing | Non-sensitizer / Pass |
| Acute Systemic Toxicity | Acute Systemic Toxicity | Non-acute systemic toxicity | Did not show acute systemic toxicity in vivo. / Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). However, for the watertightness test (ASTM D5151/ASTM D6319), it reports "0/125/Pass" which indicates a sample size of 125 gloves were tested for holes, and none failed.
The non-clinical tests were conducted to verify that the proposed device met all design specifications according to recognized standards. The identity of the testing laboratories or the origin of the samples is not specified in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document describes non-clinical performance testing of a physical device (gloves). Therefore, there is no "ground truth" derived from expert interpretation of medical images or data in the typical sense. The ground truth for these tests is established by the specified standards (ASTM and ISO standards) themselves, which outline quantitative metrics and methodologies for evaluation. No human experts are explicitly mentioned as establishing ground truth for these specific tests.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative measurements against established standards, not subjective assessments requiring adjudication or consensus among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not applicable to the non-clinical performance testing of medical gloves. This type of study is typically used for evaluating the effectiveness of diagnostic or prognostic medical devices that rely on human interpretation, often with AI assistance, in comparison to human interpretation alone.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This document pertains to the physical performance of medical gloves, not a software algorithm that would operate in a standalone mode.
7. Type of Ground Truth Used
The ground truth for all tests is based on established testing standards and their quantitative acceptance criteria. For example:
- Physical dimensions are compared against numerical ranges specified in ASTM D6319-19.
- Watertightness is assessed by the absence of holes per ASTM D5151-19, with an acceptable quality level (AQL).
- Powder content is measured against a maximum limit per ASTM D6124-06.
- Tensile strength and ultimate elongation are measured against minimum requirements per ASTM D6319-19.
- Chemotherapy drug permeation is determined by breakthrough detection times as per ASTM D6978-05(2023).
- Biocompatibility tests (cytotoxicity, irritation, sensitization, acute systemic toxicity) are evaluated according to ISO 10993 series standards.
8. Sample Size for the Training Set
Not applicable. This document is about a physical medical device (gloves) and its non-clinical performance testing, not an AI/ML-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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(91 days)
A patient examination 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 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, blue colored, nitrile, and tested for use with chemotherapy drugs. The qloves are offered in four sizes: extra-small, small, medium, large, and extra-large.
This document describes the premarket notification (510(k)) for Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs). The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (K190860). The "device" in this context refers to the Nitrile Examination Gloves. The acceptance criteria and the study that proves the device meets them are based on non-clinical (bench) testing, as no clinical testing was performed or required for this device type.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally defined by compliance with specific ASTM and ISO standards, and the reported performance are the test results demonstrating this compliance.
| Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | |||
| ISO 10993-10:2010 (Irritation & Sensitization) | Assesses possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation, or skin sensitization. | Skin Sensitization Test: Provided grades less than 1, otherwise sensitization. Skin Irritation Test: If the primary irritation index is 0-0.4, the response category is Negligible. 0.5-1.9 means slight, 2-4.9 means moderate, 5-8 means severe. | Skin Sensitization Test: All grades are 0. All animals survived and no abnormal signs were observed. Skin Irritation Test: The primary irritation index is 0. The response of the proposed device was categorized as negligible. |
| ISO 10993-5:2009 (Cytotoxicity) | Describes test methods to assess the in vitro cytotoxicity of medical devices. | The viability (%) of the 100% extract of the test article is the final result, and if viability is reduced to <70% of the blank, it has cytotoxic potential. | Viability (%) of 100% test article extract is 86.5%. This means the proposed device has no potential toxicity to L-929 in the MTT method. |
| Physical Performance | |||
| ASTM D6124-06 (Residual Powder) | Determines the amount of residual powder (or filter-retained mass) found on medical gloves. | Powder residue limit of 2.0 mg. | 0.1 mg / glove. |
| ASTM D5151-19 (Holes) | Covers the detection of holes in medical gloves. | Samples number: 125 gloves. AQL: 2.5 (ISO 2859). Criterion $\leq$ 7 gloves for water leakage. | No glove water leakage found. |
| ASTM D6319-19 (Dimensions & Physical Properties) | Covers certain requirements for nitrile rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. | Dimensions: XS: width 70 $\pm$ 10mm, Length $\geq$ 220 mm S: width 80 $\pm$ 10mm, Length $\geq$ 220 mm M: width 95 $\pm$ 10mm, Length $\geq$ 230 mm L: width 110 $\pm$ 10mm, Length $\geq$ 230 mm XL: width 120 $\pm$ 10mm, Length $\geq$ 230 mm Thickness: Finger $\geq$ 0.05 mm, Palm $\geq$ 0.05 mm Physical properties: Before aging: Tensile strength $\geq$ 14MPa, Ultimate Elongation $\geq$ 500% After Accelerated Aging: Tensile strength $\geq$ 14MPa, Ultimate Elongation $\geq$ 400% | Dimensions: XS: width: 75-76 mm, Length 234-243 mm S: width: 86-87 mm, Length 240-248 mm M: width 98-99 mm, Length 246-256 mm L: width 109-111 mm, Length 250-258 mm XL: width 115-118mm, Length 253-255mm Thickness: Finger: 0.091-0.127 mm (range across sizes) Palm: 0.071-0.094 mm (range across sizes) Physical properties: Before aging: Tensile strength 21.6-29.5 MPa, Ultimate Elongation 536% - 571% After Accelerated Aging: Tensile strength 24.1-31.0 MPa, Ultimate Elongation 479% - 519% |
| Chemotherapy Drug Permeation | |||
| ASTM D6978-05 (Reapproved 2019) | Assesses resistance of medical gloves to permeation by chemotherapy drugs. Minimum breakthrough detection times for various chemotherapy drugs. | Carmustine (BCNU) 3.3 mg/ml: > 15.1 Minutes Cisplatin 1.0 mg/ml: > 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes Carboplatin 10.0 mg/ml: > 240 Minutes Doxorubicin HCl 2.0 mg/ml: > 240 Minutes Etoposide 20.0 mg/ml: > 240 Minutes Fluorouracil 50.0 mg/ml: > 240 Minutes Paclitaxel 6.0 mg/ml: > 240 Minutes Thio Tepa 10.0 mg/ml: > 32.8 Minutes | Carmustine (BCNU) 3.3 mg/ml: 15.1 minutes (individual results: 15.1, 16.4, 16.6) Cisplatin 1.0 mg/ml: > 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes Carboplatin 10.0 mg/ml: > 240 Minutes Doxorubicin HCl 2.0 mg/ml: > 240 Minutes Etoposide 20.0 mg/ml: > 240 Minutes Fluorouracil 50.0 mg/ml: > 240 Minutes Paclitaxel 6.0 mg/ml: > 240 Minutes Thio Tepa 10.0 mg/ml: 32.8 minutes (individual results: 48.6, 32.8, 46.1) (Note: A warning is included for Carmustine (BCNU) and Thiotepa due to low permeation times.) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set:
- Freedom from Holes (ASTM D5151-19): 125 gloves.
- Chemotherapy Drug Permeation (ASTM D6978-05): The table provides individual breakthrough detection times for some drugs, indicating multiple samples were tested (e.g., three reported times for Carmustine and Thio Tepa). Specific sample sizes for each drug are not explicitly stated beyond these examples.
- Other tests (Biocompatibility, Physical Properties, Residual Powder): Specific sample sizes are not detailed in the provided text, but testing was conducted "in accordance with" the listed standards, implying standard-appropriate sample sizes were used.
- Data Provenance: This is a 510(k) submission for a medical device (nitrile examination gloves). The testing is non-clinical (bench testing), meaning it was performed in a laboratory setting to assess the physical and chemical properties of the gloves. The country of origin of the data is not explicitly stated for each test, but the submitting company is 5R MED Instruments (CHENGDU) Co., Ltd. located in China. The testing would have been conducted in a controlled lab environment. The studies are prospective tests performed on the manufactured device to ensure it meets the required standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. For a device like examination gloves, "ground truth" is established by laboratory measurements against defined standards (e.g., strength, thickness, permeation time), not by expert human interpretation of medical images or clinical outcomes. The tests are objective, quantifiable measurements.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data (like medical images) and their discrepancies need to be resolved. For non-clinical bench testing, the results are quantitative and directly measured by calibrated equipment and documented procedures.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. MRMC studies are used to evaluate the diagnostic performance of medical imaging devices, often comparing human readers with and without AI assistance. This submission is for examination gloves, which do not involve such diagnostic tasks.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. "Standalone performance" typically refers to the performance of an AI algorithm without human involvement. This device is not an AI algorithm. Its performance is demonstrated through physical and chemical property testing.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is objective, measurable physical properties and chemical resistance, defined by international standards:
- Standard-defined thresholds: For properties like tensile strength, elongation, freedom from holes (AQL), residual powder, dimensions (length, width, thickness), and breakthrough times for chemotherapy drugs.
- Laboratory measurements: Results obtained from standardized test methods (ASTM, ISO).
- Biocompatibility assessments: Based on established criteria for irritation, sensitization, and cytotoxicity from biological assays.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML model. There is no "training set" in the context of examination gloves.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it. The ground truth for the device's performance is based on its physical, chemical, and biological properties measured against established standards during non-clinical testing.
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