(211 days)
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.
The proposed devices are Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim. The gloves are available in two colors: blue and white. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document is a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White)" and "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue)". This document is for a medical device (gloves) and not for an AI/ML-driven medical device or software. Therefore, the questions related to AI/ML device testing (such as sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to the content provided.
However, I can extract the acceptance criteria and the study results for the glove's performance as presented in the document, especially regarding its resistance to chemotherapy drugs and other physical properties.
Here's the information based on the provided document, addressing the relevant points and indicating "N/A" for those that do not apply to this type of device:
Device Description: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the gloves are primarily based on ASTM standards and comparisons to a predicate device (K141982). The key performance characteristic tested for this submission is the "Breakthrough Detection Time" for various chemotherapy drugs, which reflects the glove's ability to protect against exposure.
Acceptance Criteria & Device Performance Comparison (Current Device vs. Standards/Predicate)
| Characteristic | Standard / Predicate Acceptance Criteria (Predicate 1: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves Tested for Use with Chemotherapy Drugs, K141982) | Current Device Performance (White Gloves) | Current Device Performance (Blue Gloves) |
|---|---|---|---|
| Physical Properties | |||
| Length | Min 240mm (ASTM D6319-10(2015)) | Min 240mm | Min 240mm |
| Width (medium glove) | Min 85 mm (ASTM D6319-10(2015)) | Min 85 mm | Min 85 mm |
| Tensile Strength (before aging) | Meets min 14Mpa (ASTM D6319-10(2015)) | Meets min 14Mpa | Meets min 14Mpa |
| Tensile Strength (after aging) | Meets min 14Mpa (ASTM D6319-10(2015)) | Meets min 14Mpa | Meets min 14Mpa |
| Elongation (before aging) | Meets min 500% (ASTM D6319-10(2015)) | Meets min 500% | Meets min 500% |
| Elongation (after aging) | Meets min 400% (ASTM D6319-10(2015)) | Meets min 400% | Meets min 400% |
| Thickness – Finger | Meets min 0.05 mm (ASTM D6319-10(2015)) | Meets min 0.05 mm | Meets min 0.05 mm |
| Thickness – Palm | Meets min 0.05 mm (ASTM D6319-10(2015)) | Meets min 0.05 mm | Meets min 0.05 mm |
| Powder Content | ≤ 2 mg/glove (ASTM D6124-06(2011)) | Meets | Meets |
| Watertight (1000ml) | Passes (21 CFR 800.20, ASTM D5151) | Passes | Passes |
| Biocompatibility | |||
| Primary Skin Irritation | Non-irritating (ISO 10993-10:2010) | Non-irritating | Non-irritating |
| Dermal Sensitization | Non-sensitizing (ISO 10993-10:2010) | Non-sensitizing | Non-sensitizing |
| Chemotherapy Drug Permeation Test (ASTM D6978-05) | Predicate Breakthrough Detection Time (min) | Current Device White Gloves Breakthrough Detection Time (min) | Current Device Blue Gloves Breakthrough Detection Time (min) |
| Cisplatin, 1.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Cyclophosphamide, 20.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Doxorubicin HCl, 2.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Etoposide (Toposar), 20.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Fluorouracil, 50.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Ifosfamide, 50.0 mg/ml | >240 (Predicate only, current device not tested for this) | N/A | N/A |
| Mitoxantrone, 2.0 mg/ml | >240 (Predicate only, current device not tested for this) | N/A | N/A |
| Vincristine Sulfate, 1.0 mg/ml | >240 (Predicate only, current device not tested for this) | N/A | N/A |
| Carmustine (BCNU) 3.3mg/ml | 15.0 | 24.0 | 18.2 |
| Thiotepa 10.0 mg/ml | 2.0 | 54.9 | 57.3 |
| Warning Statement | Identical warning regarding low permeation times for Carmustine and Thiotepa. | Identical warning, updated times based on testing. | Identical warning, updated times based on testing. |
Note: For Carmustine and Thiotepa, while the breakthrough times might seem low, the predicate also had low times (Thiotepa as low as 2 minutes). The current device shows improved or comparable performance for these challenging drugs, and the critical acceptance criterion is that the warning statement regarding these drugs' properties is present and updated to reflect the tested performance.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for each specific test (e.g., number of gloves tested for chemotherapy permeation or physical properties). However, the testing would have been conducted in accordance with the cited ASTM standards, which define the necessary sample sizes and testing methodologies for such evaluations.
- Data Provenance: The device is manufactured by Comfort Rubber Gloves Industries Sdn Bhd in Matang, Perak, Malaysia. The testing data would originate from laboratory tests conducted on the manufactured gloves.
- Retrospective or Prospective: These tests are prospective (pre-market) evaluations conducted specifically to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical device where "ground truth" is established through standardized laboratory testing protocols (e.g., ASTM D6978 for chemotherapy drug permeation, ASTM D6319 for physical properties, ISO 10993 for biocompatibility) that yield objective measurements, rather than expert interpretation of complex data (like medical images).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not applicable for physical device performance testing.
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
N/A. Not applicable for this physical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. Not applicable for this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements derived from standardized laboratory test methods (e.g., ASTM standards for glove performance and ISO standards for biocompatibility). For instance, the breakthrough detection time for chemotherapy drugs is a direct measurement based on chemical analysis, not expert consensus or clinical outcomes.
8. The sample size for the training set
N/A. This document pertains to a physical medical device (gloves), not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
N/A. This document pertains to a physical medical device (gloves), not an AI/ML system.
§ 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.