(60 days)
A powder-free patient examination glove is a disposable device intended for use medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and use for use with chemotherapy drugs.
In addition these gloves were tested for use with chemotherapy drugs in accordance 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 color, 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 document describes the acceptance criteria and performance of the "EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy Drugs." This is a medical device, not an AI/ML device, so many of the requested fields are not applicable.
Here's the information extracted and formatted as requested, with "N/A" for fields that are not relevant to this type of device:
Acceptance Criteria and Device Performance for EMG Blue Nitrile Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria | Reported Device Performance (K171339) | Comparison to Predicate (K161187) |
|---|---|---|---|
| Product Code | LZA and LZC | LZA and LZC | Same |
| Intended Use | A powder-free 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. The device is for over-the-counter use. Intended use with chemotherapy drugs in accordance with ASTM D6978-05. | A powder-free 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. The device is for over-the-counter use. Intended use with chemotherapy drugs in accordance with ASTM D6978-05. | Same |
| Material Use | Nitrile latex compound | Nitrile latex compound | Same |
| Color | Blue | Blue | Same |
| Sterility | Non sterile | Non sterile | Same |
| Single Use | Single used | Single used | Same |
| Dimensions | Overall Length (mm): Min 230 mm | ||
| Width (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm | |||
| Thickness at Palm (mm): Min 0.05 mm | |||
| Thickness at Finger Tip (mm): Min 0.05 mm | Size: Medium | ||
| Palm Width: 98 mm | |||
| Length: 247 mm | |||
| Finger Thickness: 0.08mm | |||
| Palm Thickness: 0.05mm | |||
| (Meets ASTM D6319-10) | Size: Medium | ||
| Palm Width: 99 mm | |||
| Length: 247 mm | |||
| Finger Thickness: 0.11mm | |||
| Palm Thickness: 0.07mm | |||
| (Meets ASTM D6319-10) | |||
| Overall dimensions are considered "Same" for substantial equivalence based on meeting the ASTM standard. | |||
| Physical Properties | Before Ageing: Tensile Strength (MPa) = Min 14 Mpa, Ultimate Elongation (%) = Min 500 % | ||
| After Aging at 70°C for 168 hrs @ 100°C for 22 hrs: Tensile Strength (MPa) = Min 14 Mpa, Ultimate Elongation (%) = Min 400 % | Tensile strength (Mpa): Before aging: 25.45Mpa, After Accelerated aging: 26.33Mpa | ||
| Ultimate Elongation(%): Before aging: 600%, After aging: 550% | |||
| (Meets ASTM D6319-10) | Tensile strength (Mpa): Before aging: 25.45Mpa, After Accelerated aging: 26.33Mpa | ||
| Ultimate Elongation(%): Before aging: 600%, After aging: 550% | |||
| (Meets ASTM D6319-10) | |||
| This indicates the predicate also met these criteria, confirming "Same". | |||
| Freedom from Pinholes | AQL 2.5 (Inspection Level G-1) | AQL 2.5 (Inspection Level G-1) | AQL 2.5 (Meets ASTM D5151-06) |
| The device meets the same AQL and inspection level. | |||
| Residual Powder | 24.0 Minutes | ||
| Cyclophosphamide (20 mg/ml): Minimum Breakthrough detection time: > 240 Minutes | |||
| Thiotepa (10mg/ml): Minimum Breakthrough detection time: > 56.9 Minutes | |||
| (Note: Max testing time is 240 minutes) | Carmustine (BCNU)(3.3 mg/ml): 24 minutes | ||
| Cyclophosphamide (20 mg/ml): > 240 minutes | |||
| Thiotepa (10mg/ml): 56.9 minutes | |||
| List includes 15 drugs, with most showing >240 minutes breakthrough time. Specific values for Carmustine and Thiotepa are noted as having low permeation time. | The Indications for Use section (pages 2-3 and 10-11) lists the same 15 chemotherapy drugs and concentrations with identical "Minimum Breakthrough Detection Time" values for both the subject device (K171339) and the predicate (K161187) (as detailed on page 2 and stated in the comparison for substantial equivalence). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Physical/Chemical Tests: Not explicitly stated as a single number. The testing is based on ASTM standards (D6319-10, D5151-06, D6124-06) which prescribe sampling plans for quality control (e.g., AQL for pinholes).
- Sample Size for Chemotherapy Permeation: Not explicitly stated. ASTM D6978-05, the standard referenced, outlines the methodology for testing permeation, which would involve multiple samples.
- Data Provenance: The testing was conducted to meet established ASTM and ISO standards. The manufacturer is ECO MEDI GLOVE SDN. BHD. based in Malaysia. The tests appear to be prospective for the purpose of demonstrating substantial equivalence.
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, and its performance is measured against objective standards (ASTM, ISO) and laboratory tests, not subjective expert judgment for ground truth establishment.
4. Adjudication method for the test set:
- N/A: Not applicable for objective physical and chemical 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: This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A: This is not an AI/ML device. The "standalone" performance refers to the glove's physical and chemical properties.
7. The type of ground truth used:
- Objective Standards and Laboratory Measurements: The "ground truth" for this device is based on its ability to meet the specifications outlined in recognized international standards (ASTM D6319-10 for nitrile gloves, ASTM D6978-05 for chemotherapy drug permeation, ASTM D5151-06 for pinholes, ASTM D6124-06 for residual powder, and ISO 10993-10 for biocompatibility). These are quantifiable, objective measurements.
8. The sample size for the training set:
- N/A: There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- N/A: There is no "training set" for this type of device.
§ 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.