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510(k) Data Aggregation
(199 days)
A 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.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Flourouracil (Adrucil) | 50.0mg/ml | > 240 |
| Etopside (Toposar) | 20.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| *Carmustine (BCNU) | 3.3mg/ml | 15.0 |
| *Thiotepa | 10.0mg/ml | 2.0 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| Doxorubicin Hydrochloride (Adriamycin) | 2.0mg/ml | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 |
| Cisplatin | 1.0mg/ml | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
- Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) : 15 minutes and Thiotepa : 2 minutes
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile meets all the requirements of ASTM standard D6319-10, D6978-05 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the qlove surface. The qlove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meets ASTM standard D6319-10.
The provided document describes the acceptance criteria and performance of the "Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for use with Chemotherapy Drugs" to demonstrate substantial equivalence to a predicate device (Kimberly-Clark STERLING Nitrile Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim, K081089).
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to various ASTM standards and performance comparable to the predicate device. The reported device performance indicates compliance with these standards.
| Characteristic | Standard/Acceptance Criteria | Reported Device Performance (Current Device) | Predicate Device Performance |
|---|---|---|---|
| Physical Properties | ASTM D6319-10 | Meets | Meets |
| Dimensions | ASTM D6319-10 (Min 240mm length) | Min 240mm | Conforms to ASTM 6319-00a |
| Thickness - Finger | ASTM D6319-10 (0.07 - 0.10mm) | 0.07 - 0.10mm | 0.07 - 0.10mm |
| Thickness - Palm | Not explicitly stated as a separate standard, but implied by D6319-10 (0.07 – 0.09mm) | 0.07 – 0.09mm | 0.07 – 0.09mm |
| Thickness - Cuff | Not explicitly stated as a separate standard, but implied by D6319-10 (0.06 - 0.08mm) | 0.06 - 0.08mm | 0.06 - 0.08mm |
| Powder Free | ASTM D6124-06 (≤ 2 mg/glove) | Meets | Meets |
| Chemotherapy Drug Permeation | ASTM D6978-05 (Breakthrough Detection Time) | See specific drug results below | See specific drug results below |
| Flourouracil (Adrucil) | > 240 minutes | > 240 minutes | > 240 minutes |
| Etopside (Toposar) | > 240 minutes | > 240 minutes | > 240 minutes |
| Cyclophosphamide (Cytoxan) | > 240 minutes | > 240 minutes | > 240 minutes |
| *Carmustine (BCNU) | Not explicitly stated for current device, but predicate has no listed value. Current device reports 15 minutes. | 15.0 minutes | - |
| *Thiotepa | Not explicitly stated for current device, but predicate reports 54.2 minutes. Current device reports 2 minutes. | 2.0 minutes | 54.2 minutes |
| Paclitaxel (Taxol) | > 240 minutes | > 240 minutes | > 240 minutes |
| Doxorubicin Hydrochloride | > 240 minutes | > 240 minutes | > 240 minutes |
| Dacarbazine | > 240 minutes | > 240 minutes | > 240 minutes |
| Cisplatin | > 240 minutes | > 240 minutes | > 240 minutes |
| Ifosfamide | > 240 minutes | > 240 minutes | > 240 minutes |
| Mitoxantrone | > 240 minutes | > 240 minutes | > 240 minutes |
| Vincristine Sulfate | > 240 minutes | > 240 minutes | > 240 minutes |
| Biocompatibility | ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (Primary Skin Irritation) | Passes (Not a primary skin irritant) | Passes |
| ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3(c)(4) (Dermal Sensitization) | Passes (Not a contact sensitizer) | Passes | |
| Watertight | ASTM D5151-06 | Passes | Passes |
| Intended Use | Prevention of contamination between patient and examiner | Consistent with predicate | Consistent with predicate |
| Material | ASTM D6319-10 (Nitrile) | Nitrile | Nitrile |
| Color | Not a performance criterion, but a characteristic | Blue | Light Gray |
| Texture | Not a performance criterion, but a characteristic | Finger textured | Textured Fingertip |
| Size | Medical Glove Guidance Manual - Labeling (XS, S, M, L, XL) | Extra Small, Small, Medium, Large, Extra Large | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Glove Guidance Manual - Labeling | Single use | Single use |
| Warning Statement | - | Required for drugs with low permeation times | Required for drugs with low permeation times |
Study Proving Device Meets Acceptance Criteria:
The studies cited are non-clinical performance tests conducted to demonstrate compliance with recognized industry standards. The submission explicitly states that "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)." This implies specific tests were performed on the device to prove its compliance with each standard.
2. Sample size used for the test set and the data provenance
- The document does not specify the sample sizes used for the individual tests (e.g., how many gloves were tested for permeation, physical properties, or biocompatibility).
- The data provenance is non-clinical test data, performed by the manufacturer, WRP Asia Pacific Sdn Bhd, located in Malaysia. The tests are reported as being compliant with internationally recognized ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable to this type of submission. The "ground truth" for glove performance is established by adherence to standardized testing protocols (e.g., ASTM D6978-05 for chemotherapy drug permeation), not by expert consensus in a clinical setting.
- The document does not mention any medical experts' involvement in establishing test results or ground truth. The tests are laboratory-based.
4. Adjudication method for the test set
- Not applicable. Adjudication methods are typically associated with human interpretation of results, often in clinical or image-based studies. Here, the results are quantitative measurements against predefined standard thresholds.
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 submission for medical gloves, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This involves physical product performance, not an algorithm.
7. The type of ground truth used
- The "ground truth" for the device's performance is compliance with established, quantitative, and standardized test methods (e.g., ASTM D6319-10 for physical characteristics, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993-10 for biocompatibility, and ASTM D5151-06 for watertightness). The results are direct measurements against these standards.
8. The sample size for the training set
- Not applicable. This device is a physical product (gloves) and does not involve machine learning or AI, thus there is no "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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