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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 ± 10 mm | 84-86/Pass |
| Width (M) | Physical Dimensions Test | 95 ± 10 mm | 96-102/Pass |
| Width (L) | Physical Dimensions Test | 110 ± 10 mm | 104-107/Pass |
| Width (XL) | Physical Dimensions Test | 120 ± 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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