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510(k) Data Aggregation
(129 days)
The Gen 2 Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was 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 Blue Nitrile Examination gloves, with claiming, this product contains Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile 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.
The provided text is related to the FDA 510(k) premarket notification for a medical device: "GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims." It outlines the device's characteristics, intended use, and the tests performed to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the studies mentioned, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General Physical Properties (ASTM D6319-10) | ||
| Overall Length (mm) | Min 230mm | Meets ASTM D6319-10 (Implies compliance with length requirements) |
| Width (±5mm) | Size S= 85mm, Size M= 95mm, Size L= 105mm, Size XL= 115mm | Meets ASTM D6319-10 (Implies compliance with width requirements) |
| Thickness at Palm (mm) | Min 0.05 mm | Meets ASTM D6319-10 (Implies compliance with palm thickness requirements) |
| Thickness at Finger Tip (mm) | Min 0.05 mm | Meets ASTM D6319-10 (Implies compliance with fingertip thickness requirements) |
| Tensile Strength (MPa) - Before Ageing | 14 min | 14 min (Explicitly stated in Section 7.2) / Meets ASTM D6319-10 |
| Ultimate Elongation (%) - Before Ageing | 500 min | 500 min (Explicitly stated in Section 7.2) / Meets ASTM D6319-10 |
| Tensile Strength (MPa) - After Aging | 14 min | 14 min (Explicitly stated in Section 7.2) / Meets ASTM D6319-10 |
| Ultimate Elongation (%) - After Aging | 400 min | 400 min (Explicitly stated in Section 7.2) / Meets ASTM D6319-10 |
| Freedom from Holes (ASTM D5151-06) | ||
| Pin-hole Level | AQL 2.5, Inspection Level G-1 | AQL 2.5, Inspection Level G-1 (Explicitly stated in Section 7.2) / Meets ASTM D5151-06 |
| Powder-free residue (ASTM D6124-06) | ||
| Residual Powder | ≤ 2.0 mg/glove | Meets ASTM D6124-06 (Implies compliance) |
| Biocompatibility (ISO 10993-10, ISO 10993-5) | ||
| Primary Skin Irritation | The test article was a non-irritant. | Test article is non-irritant |
| Dermal Sensitization | The test article was a non-sensitizer. | Test article is non-sensitizer |
| In vitro Cytotoxicity | The test article was not cytotoxic. | The test article was not cytotoxic (Stated in Section 9.0 Summary) |
| Resistance against Chemotherapy Drugs (ASTM D6978-05) | ||
| Carmustine (3.3mg/ml) | 22 min breakthrough | 22 min breakthrough |
| Cisplatin (1.0mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Cyclophosphamide (20mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Methotrexate (25mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Doxorubicin HCl (2.0mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Etoposide (20.0mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Fluorouracil (50.0mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Paclitaxel (6.0mg/ml) | No breakthrough up to 240 min | No breakthrough up to 240 min |
| Thiotepa (10.0mg/ml) | 47.4 min breakthrough | 47.4 min breakthrough |
| Low Dermatitis Potential Claim | ||
| Modified Draize 95 test | No clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects | Test article did not induce type IV allergy to human; 205 non-sensitized adult human subjects gave all negative results. |
2. Sample Size Used for the Test Set and the Data Provenance
-
Low Dermatitis Potential Claim (Clinical Study):
- Sample Size:
- Stage 1: 30 human subjects
- Stage 2 (Total): Minimum 205 individuals (including the initial 30). The study was completed on 205 adult human subjects.
- Data Provenance: The document states the subjects "reasonably reflect the general user population in the US." No explicit country of origin for the data collection is specified beyond this, but the company is in Malaysia, suggesting the study might have been conducted there or in the US with a US-representative population. The study is prospective, as it involves human testing for irritation and sensitization.
- Sample Size:
-
Chemotherapy Drug Permeation and other ASTM/ISO tests: The document does not specify the sample size for these non-clinical tests. These tests are typically conducted on a representative number of glove samples according to the respective standard (e.g., a batch of gloves). The data provenance is industrial testing, likely from the manufacturer's quality control processes in Malaysia, as it refers to meeting ASTM standards rather than specific patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- For the clinical study (Low Dermatitis Potential Claim): The document does not explicitly state the "number of experts" or their specific "qualifications" involved in establishing the ground truth of skin irritation/sensitization. The ground truth would be based on the clinical observations of the human subjects by qualified medical professionals conducting the Modified Draize 95 test.
- For non-clinical tests (ASTM/ISO): Ground truth is established by the test methods specified in the standards themselves, not typically by human experts reviewing individual cases. The results are quantitative measurements against defined criteria.
4. Adjudication Method for the Test Set
- For the clinical study (Low Dermatitis Potential Claim): The document does not specify an adjudication method like 2+1 or 3+1. The results are presented as direct observations ("all negative results," "no clinical evidence of... Type IV allergy"). This suggests direct observation and interpretation by the clinicians conducting the study.
- For non-clinical tests: Adjudication methods like those for interpreting medical images are not applicable here. The tests involve direct measurement against a standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a nitrile examination glove, not an AI-powered diagnostic algorithm or imaging device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance study of the device itself.
- Yes, for the physical and chemical properties: The ASTM and ISO standard tests (e.g., tensile strength, pinholes, chemotherapy drug permeation, biocompatibility) are standalone evaluations of the glove material and design performance. They are conducted without human intervention in the loop other than performing the test itself.
- Yes, for the clinical dermatological claim: The Modified Draize 95 Test is a standalone assessment of the glove's potential to cause skin irritation or sensitization on human subjects.
7. The Type of Ground Truth Used
- Low Dermatitis Potential Claim: Clinical observation / Outcomes data (absence of irritation/sensitization in human subjects after exposure).
- Chemotherapy Drug Resistance: Laboratory measurement against established permeation thresholds (quantitative data defined by ASTM D6978-05).
- Physical Properties (Tensile Strength, Elongation, Dimensions, Pin-holes): Laboratory measurement against specified physical standards (quantitative data defined by ASTM D6319-10 and ASTM D5151-06).
- Powder-free Residue: Laboratory measurement (quantitative data defined by ASTM D6124-06).
- Biocompatibility (Cytotoxicity): Laboratory measurement (quantitative or qualitative data defined by ISO 10993-5).
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as this is not an AI/machine learning device. The studies described are for validation/testing of the final product.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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(156 days)
The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was 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 Blue Nitrile Examination gloves, with Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and nonsterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05 and Modified Draize 95 test.
The provided document describes the safety and performance characteristics of a Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims (K181066), rather than an AI/ML powered medical device. Therefore, much of the requested information (e.g., AI/ML specific acceptance criteria, sample sizes for test/training sets, ground truth establishment methods, MRMC studies, standalone performance studies) is not applicable or available within this document.
However, I can extract and present the available information regarding the glove's acceptance criteria and the studies conducted to demonstrate its performance against those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Product Code | LZA, LZC | LZA, LZC |
| 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. | 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. |
| Material Use | Nitrile compound | Nitrile compound |
| Color | Blue | Blue |
| Sterility | Non sterile | Non sterile |
| Single Use | Single used | Single used |
| Dimensions | Overall Length (mm): Min 230mmWidth (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mmThickness at Palm (mm): Min; 0.05 mmThickness at Finger Tip (mm): Min 0.05 mm | Min 230mm (for length, width, and thickness values are specific to the given sizes and meet min 0.05mm for Palm and Finger Tip). |
| Physical Properties | Before Ageing:Tensile Strength (MPa) = 14minUltimate Elongation (%) = 500minAfter Aging at 70ºC for 168 hrs @ 100℃ for 22 hrs:Tensile Strength (MPa) = 14minUltimate Elongation (%) = 400min | Before aging:Tensile strength: Min 14 MpaUltimate Elongation: Min 500%After Aging:Tensile strength: Min 14 MpaUltimate Elongation: Min 400% |
| Freedom from pinholes | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-06 (which specifies AQL 2.5, Inspection Level G-1) |
| Residual Powder | ≤ 2.0 mg/pc | ≤ 2.0 mg/pc |
| Biological Evaluation on Medical Device - Primary Skin Irritation Test | Not explicitly stated as a numerical value, but implied to be non-irritant. | Under the conditions of this study, the test article was a non-irritant. |
| Biological Evaluation on Medical Device - Dermal Sensitization Assay | Not explicitly stated as a numerical value, but implied to be non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. |
| ISO 10993-5:2009 Biological Evaluation of Medical Device - Part 5: Test for In Vitro Cytotoxicity | Not explicitly stated as a numerical value, but implied to be non-cytotoxic. | Under the conditions of this study, the test article was not cytotoxic. |
| Resistance against Chemotherapy Drugs (Minimum Breakthrough Detection time in minutes) | ||
| 1) Carmustine (BCNU)(3.3 mg/ml) | 12.9 min | |
| 2) Cisplatin (1.0 mg/ml) | No breakthrough up to 240 min | |
| 3) Cyclophosphamide (Cytoxan)(20 mg/ml) | No breakthrough up to 240 min | |
| 4) Dacarbazine (DTIC) (10.0 mg/ml) | No breakthrough up to 240 min | |
| 5) Doxorubicin Hydrochloride (2.0 mg/ml) | No breakthrough up to 240 min | |
| 6) Etoposide (Toposar)(20.0 mg/ml) | No breakthrough up to 240 min | |
| 7) Fluorouracil (50.0 mg/ml) | No breakthrough up to 240 min | |
| 8) Paclitaxel (Taxol)(6.0 mg/ml) | No breakthrough up to 240 min | |
| 9) Thiotepa (10.0 mg/ml) | 24.7 min | |
| Low Dermatitis Potential Claim | No clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects | No Clinical evidence presence of residual chemical additives that may induce Type IV allergy in human subject |
2. Sample Sizes Used for the Test Set and Data Provenance
- Physical and Chemical Tests: The document refers to compliance with various ASTM standards (D6319-10, D5151-06, D6124-06, D6978-05). These standards prescribe specific sampling plans and test methods. The exact sample sizes used for each of these physical and chemical tests are not explicitly stated in this summary. The data provenance would be from laboratory testing according to these standards.
- Biocompatibility/Low Dermatitis Potential Claim:
- Sample Size: A total of 205 human subjects were tested for the Modified Draize-95 test. This involved an initial population of 30, with a further number added to reach 205.
- Data Provenance: The study was a prospective human subject test conducted to evaluate the potential for irritation or sensitization. The document states the subjects "reasonably reflect the general user population in the US." The country of origin of the data is not explicitly stated, but the mention of "human subjects...in the US" could imply the study was conducted there, or at least designed to reflect a US population's response.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For the physical and chemical tests (e.g., tensile strength, pinholes, chemotherapy drug permeation), the "ground truth" is established by the direct measurement or observation of the glove's performance against the objective criteria set by the ASTM standards. No human consensus "experts" are typically involved in establishing this type of ground truth beyond the trained personnel performing the tests according to the standard operating procedures.
- For the Low Dermatitis Potential Claim, the "ground truth" was established by the clinical observations of the 205 human subjects during the Modified Draize-95 test. The document states, "The study completed on 205 non sensitized adult human subjects... gave all negative results. There was no clinical evidence of the presence of residual chemical additives that may induce Type IV allergy..." This implies clinical evaluation by medical professionals, but the number and specific qualifications of these experts are not provided in the document.
4. Adjudication Method for the Test Set
- For the physical and chemical tests, adjudication is based on whether the measured values meet the specified criteria in the ASTM standards.
- For the Low Dermatitis Potential Claim via the Modified Draize-95 test, the outcome ("all negative results," "no clinical evidence") suggests a direct observation and interpretation by clinical evaluators rather than a formal multi-reader adjudication process like 2+1 or 3+1. The methodology would follow the specified FDA guidance document referenced.
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 document describes a medical glove, not an AI/ML powered device. Therefore, no MRMC study involving human readers with or without AI assistance was conducted or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This document describes a medical glove, not an AI/ML powered device. Therefore, no standalone algorithm performance study was conducted or reported.
7. The Type of Ground Truth Used
- Objective Measurement/Standard Compliance: For physical properties (dimensions, tensile strength, elongation, pinholes, residual powder) and chemotherapy drug resistance, the ground truth is based on direct laboratory measurements and adherence to established ASTM standards.
- Clinical Observation: For the biocompatibility claims (primary skin irritation, dermal sensitization, cytotoxicity) and the low dermatitis potential claim, the ground truth is based on clinical observations and laboratory assays as per ISO 10993-10:2010, ISO10993-5, 16 CFR Part 1500.41, and the Modified Draize-95 test results on human subjects.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI/ML component, there is no training set or ground truth establishment for such a set.
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(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.
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(112 days)
A Powder Free Examination Glove is a disposable device intended for Medical Purpose that is worn on the examiner's hand of fingers to prevent contamination between patient and examiner 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 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.
This document describes the validation of the "EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs" (K141623) by establishing its substantial equivalence to a legally marketed predicate device (K110921). The "device" in this context refers to these medical examination gloves.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparative table between the subject device (K141623) and the predicate device (K110921), outlining acceptance criteria for various characteristics and how both devices perform against them.
| Characteristics | Acceptance Criteria | EMG Blue Nitrile Medical Examination Gloves Powder Free with tested for use with chemotherapy drugs (K141623) (Reported Performance) | Nitrile Cornflower Blue Powder Free gloves tested for use with Chemotherapy drugs (Non-Sterile ), K110921 (Predicate Performance) |
|---|---|---|---|
| Product Code | LZC | LZC | LZC |
| 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. Also, tested for use with chemotherapy drugs. | Meets the description: 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. | Meets the description: 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. |
| Material use | Nitrile latex compound | Nitrile latex compound | Nitrile latex compound |
| Colour | Blue | Blue | Blue |
| Sterility | Non sterile | Non sterile | Non sterile |
| Single used | Single used | Single used | Single used |
| Dimensions | Overall Length (mm) Min 270mmWidth (± 5mm) Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mmThickness at Palm (mm) Min; 0.10mmThickness at Finger Tip (mm) Min 0.10 mm | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Physical properties | Before Ageing: Tensile Strength (MPa) = 14min, Ultimate Elongation (%) = 500minAfter Aging at 70°C for 168 hrs @ 100°C for 22 hrs: Tensile Strength (MPa) = 14min, Ultimate Elongation (%) = 400min | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Freedom from pinholes | AQL 2.5 Inspection Level G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Biological Evaluation on Medical Device - Primary Skin Irritation Test | Non-irritant | Under the conditions of this study, the test article was a non-irritant. | Under the conditions of this study, the test article was a non-irritant. |
| Biological Evaluation on Medical Device - Dermal Sensitization Assay | Non-sensitizer | Under the conditions of this study, the test article was a non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. |
| Resistance against Chemotherapy Drugs (ASTM D6978-05 Standards for Breakthrough Time) | Carmustine (BCNU) (3.3mg/ml): Min Breakthrough detection time in Minutes, 0.01µg/cm²/minute: Not explicitly stated as acceptance criteria, but listed as observed performance. | 1) Carmustine (3.3mg/ml): 1.3 minutes2) Cyclophosphamide (20mg/ml): > 240 minutes3) Cytarabine (100mg/ml): > 240 minutes4) Doxorubicin Hydrochloride (2 mg/ml): > 240 minutes5) Etoposide (20mg/ml): > 240 minutes6) Fluorouracil (50mg/ml): > 240 minutes7) Methorexate (25mg/ml): > 240 minutes8) Paclitaxel (6mg/ml): > 240 minutes9) Thiotepa (10mg/ml): 67.8 minutes | 1) Carmustine (3.3mg/ml): 4.5min.2) Cyclophosphamide (20mg/ml): >240 min.3) Cytarabine (100mg/ml): >240 min.4)Doxorubicin Hydrochloride (2.0mg/ml): >240 min.5) Etoposide (20mg/ml): >240 min.6) Flourouracil (50mg/ml): >240 min.7) Methorexate (25mg/ml): > 240 min.8) Paclitaxel (6mg/ml): >240 min.9) Thiotepa (10mg/ml): 6.88 min. |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a substantial equivalence demonstration based on performance testing and comparison to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, or how many individual glove samples were used for chemotherapy permeation per drug). However, the general acceptance criteria for "Freedom from pinholes" adheres to AQL 2.5, Inspection Level G-1, which implies a sampling plan defined by ASTM D5151-06. The dimensions, physical properties, and residual powder also refer to ASTM standards (D6319-10 and D6124-06) which include sampling plans. For the chemotherapy drug permeation, it states "Minimum Breakthrough detection time" for each drug, which is typically derived from a set of tests.
- Data Provenance: The manufacturing company is ECO MEDI GLOVE SDN. BHD. from Malaysia. Therefore, the testing and data provenance is likely from Malaysia or conducted by a laboratory collaborating with the Malaysian manufacturer. The document doesn't specify if the data is retrospective or prospective, but given it's part of a 510(k) submission, it would be collected specifically for the purpose of demonstrating equivalence, making it effectively prospective for this regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This type of device (medical examination gloves) does not typically involve human experts establishing "ground truth" in the way a diagnostic AI device would. The "ground truth" here is objective measurement against established industry standards and regulatory requirements.
- For standards like ASTM D6319-10 (physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (residual powder), and ASTM D6978-05 (chemotherapy permeation), the "ground truth" is defined by the methodology and specifications within the standard itself, executed by trained laboratory personnel.
- For biological evaluations (skin irritation, dermal sensitization), "ground truth" is established through standardized biological testing protocols and interpreted by qualified toxicologists or biologists, although the specific number and qualifications are not detailed here.
4. Adjudication Method for the Test Set:
Not applicable in the conventional sense for this type of device. The determination of whether a glove "meets" a standard (e.g., AQL 2.5 for pinholes) is based on the objective outcome of the standardized test and the defined acceptance limits, not human expert adjudication of a diagnostic result.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI diagnostic device where human reader performance (with or without AI assistance) would be a relevant metric. The device is a physical product (gloves) whose performance is measured against physical and chemical standards.
6. Standalone Performance Study (Algorithm Only):
Not applicable. This is not an algorithm or software device. The "performance" described is that of the physical glove itself.
7. Type of Ground Truth Used:
The ground truth used is primarily based on established industry standards and physical/chemical measurements:
- Physical Specifications: Dimensions, tensile strength, ultimate elongation, freedom from pinholes (AQL 2.5, Inspection Level G-1), residual powder. These are objective measurements compared against criteria set in ASTM standards (D6319-10, D5151-06, D6124-06).
- Biocompatibility: Primary Skin Irritation Test and Dermal Sensitization Assay results (non-irritant, non-sensitizer). These are derived from biological testing protocols following standard toxicology guidelines.
- Chemical Resistance: Minimum Breakthrough Detection Time for various chemotherapy drugs, measured according to ASTM D6978-05. This involves laboratory testing where the time it takes for a chemical to permeate the glove material is objectively measured.
8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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