(307 days)
A powder-free patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger 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.
KS Medicare Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, meeting all the requirement of ASTM standards D6319-10 (Reapproved 2015), ASTM D6978-05 and ASTM D6124-06 (Reaffirmation 2011).
Principle of operation: KS Medicare Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, are non-sterile single use only, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between the patient and examiner. This powder free nitrile examination glove is manufactured from synthetic rubber. A process known as chlorination has been incorporated in the manufacturing of the gloves that don easily for the user without the addition of powder. Chlorination is a process wherein examination gloves are exposed to chlorine gas or a hypochloritehydrochloric acid mixture in order to harden the surface of the glove. The hardening of the glove surface decreases the surface friction of the glove thereby allowing for gloves to be easily donned without powder.
The gloves are ambidextrous and offered in three sizes: small, medium, and large.
This document is a 510(k) premarket notification for KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black). It aims to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs, K161422).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The primary acceptance criteria for the "Tested for Use with Chemotherapy Drugs" claim are the minimum breakthrough detection times for various chemotherapy drugs, as determined by ASTM D6978-05. The device must meet or exceed the performance of the predicate device.
Table of Acceptance Criteria (from Predicate Device K161422 – Blue glove, as reported for the Proposed Device comparison in Table 3 and Table 6) and Reported Device Performance for the Proposed Device (Blue and Black gloves):
| Test Chemotherapy Drug and Concentration | Predicate Device Breakthrough Detection Time (Minutes) (Acceptance Criteria) | Proposed Device (Blue) Breakthrough Detection Time (Minutes) (Reported Performance) | Proposed Device (Black) Breakthrough Detection Time (Minutes) (Reported Performance) |
|---|---|---|---|
| Carmustine (BCNU), 3.3 mg/ml | 15.0 | 14.8 | 22.6 |
| Cisplatin, 1.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Etoposide (Toposar), 20.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Fluorouracil, 50.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Methotrexate, 25 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Thiotepa, 10.0 mg/ml | 2.0 (Implicit, as predicate's performance is 2.0 for reference) | 35.2 | 14.0 |
Additional Acceptance Criteria (based on ASTM D6319-10 (Reapproved 2015), ASTM D6978-05, ASTM D6124-06 (Reaffirmation 2011), ASTM D5151-06, and 21CFR 800.20):
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material | Nitrile | Nitrile |
| Dimensions - Length | Meets ASTM D6319-10 (Predicate: Min. 240mm) | Proposed Device: Min. 230mm (Similar to predicate) |
| Dimensions - Width | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Dimensions - Thickness | Meets ASTM D6319-10 (Predicate: Finger 0.07-0.10mm, Palm 0.07-0.09mm) | Proposed Device: Finger Min. 0.08mm, Palm Min. 0.07mm (Similar to predicate) |
| Physical Properties - Tensile | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Physical Properties - Elongation | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Freedom from Holes | Meets ASTM D5151-06 and 21CFR 800.20 | Meets ASTM D5151-06 and 21CFR 800.20 |
| Residual Powder | Meets Powder level requirements for "Powder Free" per ASTM D6319-10 tested using ASTM D6124-06 | Meets Powder level requirements for "Powder Free" per ASTM D6319-10 tested using ASTM D6124-06 |
| Biocompatibility | Passes tests for: Primary Skin Irritation, Dermal Sensitization | Passes tests for: Primary Skin Irritation, Dermal Sensitization |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests. The document states:
"The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements)." and "It was our conclusion that KS Medicare Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs tested met all relevant requirements of the aforementioned tests."
Specifically for chemotherapy drug permeation, the gloves underwent testing in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
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 primarily describes a conformity assessment against established ASTM standards. For the chemotherapy drug permeation test (ASTM D6978-05), the number of samples used is not explicitly stated in this summary. ASTM standards typically specify minimum sample sizes for such tests. Similarly, the specific provenance (country of origin, retrospective/prospective) of the data for these performance tests is not detailed beyond the manufacturer being in Malaysia. However, compliance with ASTM standards implies a standardized testing methodology.
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 is a physical product (gloves) and not an AI or diagnostic device that requires expert ground truth for interpretation. The "ground truth" for the performance tests consists of the standardized methodologies and results defined by the relevant ASTM standards. Experts would be involved in conducting these tests according to the standards and interpreting the raw data to determine if the criteria are met, but their number and specific qualifications are not typically detailed in this type of 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human interpretation that would require an adjudication method.
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 product is a medical glove, not an AI or diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This product is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the well-defined, objective experimental procedures and measurement criteria outlined in the referenced ASTM standards (e.g., ASTM D6978-05 for chemotherapy drug permeation, ASTM D6319-10 for dimensions and physical properties, ASTM D5151-06 for freedom from holes, ASTM D6124-06 for residual powder, and biocompatibility testing standards).
8. The sample size for the training set
Not applicable. This is a physical product, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical product and does not have a "training set" in the context of an AI algorithm.
§ 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.