(135 days)
A powder-free patient eaxmination 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 for use with chemotherapy drugs.In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
The subject device in this 510(k) Notification is EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue colour, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
The Blue Nitrile Medical Examination Gloves ,Powder Free, 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 (product Code LZA) and is used with chemotherapy drugs (Product code LZC). The subject device is substantially equivalent to the legally marketed Nitrile Medical Examination Gloves (product Code LZA and LZC).
The provided text describes the acceptance criteria and performance of EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs (K161187). This device is a patient examination glove and is assessed against the ASTM D6319-10 standard for Nitrile Examination Gloves and ASTM D6978-05 for permeation by chemotherapy drugs.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The core test for this device, beyond general glove properties, is its resistance to chemotherapy drugs. The acceptance criteria are implicit in the performance shown for the predicate device (K141982) and the subject device's indication to be "tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05 standards." The performance is reported as the "Minimum Breakthrough Detection Time (Min) in µg/cm²/minute." A longer breakthrough time indicates better resistance.
| Chemotherapy Drugs and Concentration | Acceptance Criteria (Implicit from ASTM D6978-05 compliance for gloves intended for chemotherapy drug use) | Reported Device Performance (EMG Blue Nitrile Examination Gloves K161187) |
|---|---|---|
| 1) Carmustine (BCNU) (3.3mg/ml) | Generally, ideally >240 minutes for many drugs, but lower for aggressive drugs is noted. For predicate, 15 µg/cm²/minute was acceptable. | 1.3 minutes |
| 2) Cyclophosphamide (20mg/ml) | > 240 minutes | > 240 minutes |
| 3) Cytarabine (100mg/ml) | > 240 minutes | > 240 minutes |
| 4) Doxorubicin Hydrochloride (2mg/ml) | > 240 minutes | > 240 minutes |
| 5) Etopside (20mg/ml) | > 240 minutes | > 240 minutes |
| 6) Fluorouracil (50mg/ml) | > 240 minutes | > 240 minutes |
| 7) Methotrexate (25mg/ml) | > 240 minutes | > 240 minutes |
| 8) Paclitaxel (6mg/ml) | > 240 minutes | > 240 minutes |
| 9) Thiotepa (10mg/ml) | Generally, ideally >240 minutes, but lower for aggressive drugs is noted. For predicate, 2 µg/cm²/minute was acceptable. | 67.8 minutes |
Note: The document explicitly states for the subject device: "The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time: Carmustine (BCNU) (3.3mg/ml) - Minimum Breakthrough detection time 1.3 μg/cm²/minute. Thiotepa (10mg/ml) - Minimum Breakthrough detection time 67.8 μg/cm²/minute." This highlights that even with lower breakthrough times for these specific drugs, if tested according to the standard, the device is considered to meet the "tested for use with chemotherapy drugs" indication. The predicate device also showed similar, and in one case even lower (Thiotepa, 2 minutes), breakthrough times for these aggressive drugs.
Beyond chemotherapy drug resistance, the document also details other specifications that the gloves meet, primarily referencing ASTM D6319-10 (Standard specification for Nitrile Examination Gloves):
| Characteristic | Acceptance Criteria (from ASTM D6319-10) | Reported Device Performance (EMG Blue Nitrile Examination Gloves K161187) |
|---|---|---|
| Overall Length | Min 230 mm | Meets ASTM D6319-10 (Specific values for different sizes are S, M, L, XL all 230mm minimum) |
| Width | Size S = 85mm, M = 95mm, L = 105mm, XL = 115mm (± 5mm) | Meets ASTM D6319-10 (Specific values for different sizes are S=85, M=95, L=105, XL=115mm) |
| Thickness at Palm | Min 0.05 mm | Meets ASTM D6319-10 (Specific value is 0.05mm minimum) |
| Thickness at Finger Tip | Min 0.05 mm | Meets ASTM D6319-10 (Specific value is 0.05mm minimum) |
| Tensile Strength (Before Ageing) | 14 MPa min | Meets ASTM D6319-10 (Reported as "14min") |
| Ultimate Elongation (Before Ageing) | 500% min | Meets ASTM D6319-10 (Reported as "500min") |
| Tensile Strength (After Ageing) | 14 MPa min | Meets ASTM D6319-10 (Reported as "14min" after 70°C for 168 hrs @ 100°C for 22 hrs) |
| Ultimate Elongation (After Ageing) | 400% min | Meets ASTM D6319-10 (Reported as "400min" after 70°C for 168 hrs @ 100°C for 22 hrs) |
| Freedom from pinholes | AQL 2.5 (Inspection Level G-1) | Meets ASTM D5151-06 (This ASTM standard is referenced, not D6319-10 for pinholes, but given the "Meets" statement, it implies compliance with the stated AQL and inspection level, which are standard for examination gloves. The document states "AQL 2.5, Inspection Level G-1") |
| Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 (This ASTM standard is referenced, not D6319-10 for residual powder. Given the "Meets" statement, it implies compliance with the stated limit.) |
| Primary Skin Irritation Test | Non-irritant status | Under the conditions of this study, the test article was a non-irritant. |
| Dermal Sensitization Assay | Non-sensitizer status | Under the conditions of this study, the test article was a non-sensitizer. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the various tests (e.g., how many gloves were tested for chemotherapy permeation, physical properties, or biocompatibility). However, it consistently refers to compliance with established ASTM standards (D6319-10, D6978-05, D5151-06, D6124-06). These standards inherently define the sampling plans and testing methodologies.
- Data Provenance: The studies were performed by the manufacturer, Eco Medi Glove Sdn. Bhd., located in Malaysia. The type of study would be considered prospective testing in a laboratory setting to evaluate the device's performance against defined standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is a performance test for a physical medical device (gloves) against established engineering and material science standards (ASTM). It does not involve "ground truth" derived from expert medical opinion in the way an AI diagnostic algorithm would.
Instead, the "ground truth" (or more accurately, the pass/fail criteria) is established by the ASTM standards themselves, which are developed by experts in materials science, engineering, and medical device manufacturing. The testing would be performed by qualified laboratory technicians and engineers who are proficient in executing these standardized tests. The report does not specify the number or qualifications of these individuals directly, as their adherence to the standard methodologies is sufficient.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a direct performance test against quantitative standards, not an assessment requiring expert adjudication of a qualitative outcome. The outcomes are objective measurements (e.g., breakthrough time, tensile strength, elongation, presence of pinholes) or standardized biological evaluations (irritation, sensitization).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI assistance on their performance. This product is a physical medical device (examination gloves).
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Yes, in a sense, a standalone performance assessment was done. The glove's performance (e.g., resistance to chemotherapy drugs, physical properties, biocompatibility) was assessed independently of human interaction during its use. The "algorithm" here is the physical glove itself and its material properties, and its performance was measured directly.
7. The Type of Ground Truth Used
The "ground truth" for the performance of these gloves is based on established standard specifications and test methods.
- For physical properties and general requirements for nitrile examination gloves, the ground truth is defined by ASTM D6319-10.
- For resistance to chemotherapy drug permeation, the ground truth and test methodology are defined by ASTM D6978-05.
- For pinholes, ASTM D5151-06.
- For residual powder, ASTM D6124-06.
- For biocompatibility, the tests (Primary Skin Irritation, Dermal Sensitization) follow recognized biological evaluation standards (often ISO 10993 series, though not explicitly stated for these specific tests, but generally implied for such evaluations).
These are all objective, quantitatively measurable criteria as defined by consensus standards, not subjective expert consensus, pathology, or outcomes data in the medical sense.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm or a diagnostic tool that requires a "training set" in the context of machine learning. The "training" in manufacturing comes from process control, material selection, and quality systems, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reasons as in point 8.
§ 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.