(116 days)
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes—Extra Small, Small, Medium, Large, Extra Large and XXL.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
This is an evaluation of Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs (K213440).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are presented in the following table, derived from the "510(K) SUMMARY" (pages 11-12 of the document).
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Length | Minimum 230mm | All sizes ≥ 230mm |
| ASTM D6319-19 | Palm Width | XS: 70±10mm | |
| S: 80±10mm | |||
| M: 95±10mm | |||
| L: 110±10mm | |||
| XL: 120±10mm | |||
| XXL: 130±10mm | XS: 77-78mm | ||
| S: 86-88mm | |||
| M: 96-98mm | |||
| L: 108-110mm | |||
| XL: 116-117mm | |||
| XXL: 126-127mm | |||
| ASTM D6319-19 | Thickness | Finger: 0.05mm (min) | |
| Palm: 0.05mm (min) | Finger: ≥ 0.05mm | ||
| Palm: ≥ 0.05mm | |||
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, Before Aging | 14MPa, min | ≥ 14 MPa |
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, After Accelerated Aging | 14MPa, min | ≥ 14 MPa |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, Before Aging | 500%, min | ≥ 500% |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, After Accelerated Aging | 400%, min | ≥ 400% |
| ASTM D5151-19, ASTM D6319-19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL 2.5 requirements |
| ASTM D6124-06 (2017), ASTM D6319-19 | Powder-Content | ≤ 2 mg per glove | ≤ 2 mg, meet requirements |
| ISO 10993-10:2010 | Skin Irritation Study | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant |
| ISO 10993-10:2010 | Maximization Sensitization Study | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO 10993-5:2009 | Cytotoxicity Test | Under the conditions of this study, the test article extract showed potential toxicity (or no cytotoxic potential from predicate) | Under the conditions of this study, the test article extract showed potential toxicity |
| ISO 10993-11:2017 | Systemic toxicity | Under the conditions of this study, there was no evidence of systemic toxicity. | Under the conditions of this study, there was no evidence of systemic toxicity. |
| ASTM D6978-05 (2019) | Tested for Use with Chemotherapy Drugs | (Implicitly, minimum breakthrough times (BDT) as presented in the tables for blue and purple-blue gloves) | Details refer to the above 5.0 result (pages 6-7, 2-3 of the document for breakdown of BDT for each drug) |
2. Sample size used for the test set and data provenance
The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., for physical properties, biocompatibility, or chemotherapy drug permeation). It mentions that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" (page 11).
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 manufacturer is Luliang Hongruida Health Protection Technology Co., Ltd. (China), and the "510(K) Summary" indicates that the testing was performed to verify the device's compliance with established international and US standards (ASTM, ISO). This suggests the testing was performed specifically for the purpose of this submission (prospective in that sense).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission is for medical gloves and involves non-clinical performance testing against established standards (e.g., ASTM, ISO), which do not typically require expert consensus for ground truth establishment in the way AI/CADe devices do. The "ground truth" is defined by the technical specifications of the standards themselves (e.g., a specific tensile strength value, acceptable limits for holes, or breakthrough time metrics).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As noted above, this device does not involve a diagnostic or interpretive task that would require human expert adjudication. The tests performed are objective measurements against defined criteria.
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
Not applicable. This is a medical glove, a physical device, not an AI/CADe system. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical and chemical properties (e.g., tensile strength, freedom from holes, powder content, biocompatibility, chemotherapy drug permeation), the "ground truth" is established by the specified test methods and their defined acceptance criteria (e.g., ASTM D6319-19, ASTM D6978-05, ISO 10993 series). These are objective, measurable standards, not subject to subjective interpretation or expert consensus in the typical sense of medical image analysis. For chemotherapy drug permeation, the "ground truth" is the measured breakthrough time for each drug using the ASTM D6978-05 standard.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an algorithm that requires a training set. The performance data is derived from specific tests on samples of the manufactured gloves.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a physical device, no ground truth was established for it.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.