(126 days)
A Powder Free Patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Black Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, Black colour, powder free and non sterile.
This document is a 510(k) premarket notification for a medical device: "EMG Black Nitrile Medical Examination Glove Powder Free." It focuses on demonstrating the substantial equivalence of this new device to an existing legally marketed predicate device (K112924, RS Black Nitrile Medical Examination Gloves Powder Free).
The provided text does not describe an AI/ML-based medical device or any study involving AI/ML. Instead, it is a traditional medical device submission for examination gloves, which are physical products. Therefore, I cannot extract information related to:
- Acceptance criteria for an AI/ML device's performance.
- Sample sizes for test or training sets for AI/ML.
- Number of experts or their qualifications for AI/ML ground truth.
- Adjudication methods for AI/ML test sets.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies for AI assistance.
- Standalone performance of an AI algorithm.
- Type of ground truth used for AI/ML.
- How ground truth for a training set was established for an AI/ML device.
The document contains information on:
1. Acceptance Criteria and Reported Device Performance (for the physical glove):
The acceptance criteria and reported performance are based on the ASTM D 6319-10 standard for Nitrile Examination Gloves and other relevant ASTM standards for physical and biological properties.
| Characteristic | Acceptance Criteria | Reported Device Performance (EMG Black Nitrile Medical Examination Gloves Powder Free, K141579) |
|---|---|---|
| Physical Dimensions | Meets ASTM D6319-10 | |
| - Overall Length (mm) | 230mm min | 230mm min (all sizes) |
| - Width (± 5mm) | S=85, M=95, L=105, XL=115 | S=85, M=95, L=105, XL=115 |
| - Thickness at Palm (mm) | 0.05mm min | 0.05mm min |
| - Thickness at Finger Tip (mm) | 0.05mm min | 0.05mm min |
| Physical Properties (Before Aging) | ||
| - Tensile Strength (MPa) | 14 min | Meets ASTM D6319-10 (14 min) |
| - Ultimate Elongation (%) | 500 min | Meets ASTM D6319-10 (500 min) |
| Physical Properties (After Aging at 70°C for 168 hrs @ 100°C for 22 hrs) | ||
| - Tensile Strength (MPa) | 14 min | Meets ASTM D6319-10 (14 min) |
| - Ultimate Elongation (%) | 400 min | Meets ASTM D6319-10 (400 min) |
| Freedom from Pinholes | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-06 (AQL 2.5, Inspection Level G-1) |
| Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 |
| Biological Evaluation | ||
| - Primary Skin Irritation Test | Non-irritant | Test Article was a non-irritant |
| - Dermal Sensitization Assay | Non-sensitizer | Test Article was a non-sensitizer |
2. Sample size used for the test set and the data provenance:
The document implicitly refers to testing samples of gloves to meet the AQL (Acceptable Quality Level) standard for pinholes and other physical/biological tests. However, it does not specify the exact sample sizes used for these tests. The data provenance is from Malaysia, specifically from the manufacturing site of Eco Medi Glove SDN BHD. The data would be prospective as it's part of the premarket testing for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable for this type of medical device (physical examination gloves). Ground truth is established through standardized physical and chemical laboratory testing methods (e.g., ASTM standards), not expert interpretation.
4. Adjudication method for the test set:
Not applicable. Testing involves quantitative measurements and adherence to pass/fail criteria according to ASTM standards.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used:
The ground truth is based on objective measurements and laboratory tests performed according to established industry standards (e.g., ASTM D 6319-10, ASTM D 5151-06, ASTM D 6124-06) for physical properties (dimensions, tensile strength, elongation), freedom from pinholes, residual powder, and biological evaluations (skin irritation and sensitization).
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Eco Medi Glove SDN BHD Mr. Suresh Kumar Quality Assurance Manager Lot 23826, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Taiping, Perak Darul Ridzuan, Malaysia 34600
Re: K141579
Trade/Device Name: EMG Black Nitrile Medical Examination Glove Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 10, 2014 Received: September 12, 2014
Dear Mr. Kumar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Kumar
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141579
Device Name
EMG Black Nitrile Medical Examination Glove Powder Free
Indications for Use (Describe)
A Powder Free Patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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(formerly known as Sinetimed C nsumables Sdn. Bhd.
t 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALA YSIA. L +60-5-891 2777 FAX +60-5-891 2999
APPENDIX 2 510K#:141579
510(K) Summary EMG Black Nitrile Medical Examination Glove Powder Free .
1.0 Submitter :
| Company Name | : ECO MEDI GLOVE SDN. BHD. |
|---|---|
| Company Address | : Lot 23826,Jalan Tembaga KuningKamunting Raya Industrial Estate34600,Kamunting PerakMalaysia . |
| Contact Person | : Mr Suresh Kumar |
| Telephone No | : 603-60283033 |
| : suresh@ecomediglove.com.my |
- 2.0 Preparation Date : 03th October 2014 .
3.0 Name of the Device
Trade Name / Proprietary Name : EMG Black Nitrile Medical Examination Gloves Powder Free .
Device Name : Nitrile Patient Examination gloves .
Device Classification Name : Patient Examination gloves (21 CFR 880.6250).
Device Class : Class I .
Product Code : Nitrile-LZA .
Section 2A-1
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as Sinetimed (
t 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777
APPENDIX 2 510K#:141579
4.0 Identification of The Legally Marketed Device :
Class I patient Examination gloves,Powder Free,LZA which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.It is equivalent to K112924, RS Black Nitrile Medical Examination Gloves Powder Free ( Non-Sterile ) .
5.0 Description of Device :
Black Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, Black colour, powder free and non sterile.
6.0 Executive summary :
EMG Black Nitrile Medical Examination Glove Powder Free is a disposable glove made of nitrile latex compound Black colour powder free. This Black 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 .
6.1.1.1 Dimension and Thickness of Gloves .
6.1.1 Specification for Nitrile gloves:
| Dimension | Size S | Size M | Size L | Size XL |
|---|---|---|---|---|
| Overall Length (mm) | 230min | 230min | 230min | 230min |
| Width (± 5mm) | 85 | 95 | 105 | 115 |
| Thickness at Palm (mm) | 0.05min | 0.05min | 0.05min | 0.05min |
| Thickness at Finger Tip (mm) | 0.05min | 0.05min | 0.05min | 0.05min |
Section 2A-2
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(formerly known as Sinetimed Consumables Sdn. Bhd.)
t 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALA YSIA. TEL +60-5-891 2777 FAX +60-5-891 2999
APPENDIX 2 510K#:141579
| Measurement | Before Ageing | After Aging at 70 °C for168 hrs @ 100°C for 22 hrs |
|---|---|---|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5Inspection Level G-1 | AQL 2.5Inspection Level G-1 |
6.3.2.2 Gloves Physical Properties and Holes
Gloves meet all the specification listed in ASTM D 6319-10.
7.0 Intended use of the Device :
A Powder-free patient examination gloves 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. It is for over-the-counter use .
8.0 Summary of the Technological Characteristics of the Device compared to the Predicate Device for substantial equivalent discussion
There is no different technology characteristics compared to the predicate device . Gloves are made from nitrile latex compound, Black colour, powder free and non sterile. It is equivalent to K 112924, RS Black Nitrile Medical Examination Gloves Powder Free ( Non-Sterile ) .
| Characteristics | Acceptance Criteria | EMG Black NitrileMedical ExaminationGlovesPowder Free, K141579 | RS Black Nitrile MedicalExamination GlovesPowder Free(Non-Sterile) K112924 |
|---|---|---|---|
| Product Code | LZA | LZA | LZA |
| Intended use | A powder free patientexamination glove is adisposable device intended formedical purposes that is wornon the examiner's hand orfinger to preventcontamination between patientand examiner. The device isfor over-the-counter use. | A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner.The device is for over-the-counter use. | A powder free patientexamination glove is adisposable device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. Thedevice is for over-the-counter use. |
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(formerly known as Sinetimed Consumables Sdn. Bhd.)
Lot 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999
APPENDIX 2 510K#:141579
| Material use | Not made from Natural RubberLatex. | Nitrile latex compound. | Nitrile latex compound. | Before Ageing | |||
|---|---|---|---|---|---|---|---|
| Colour | Black | Black | Black | Tensile Strength (MPa)= Min 14min | Meets ASTM D6319-10 | ||
| Sterility | Non sterile | Non sterile | Non sterileSection 2A-3 | Ultimate Elongation (%)= Min 500min | |||
| Dimensions | Overall Length (mm)= Min 230mmWidth (± 5mm)Size S = 85mmSize M = 95mmSize L = 105mmSize XL = 115mmThickness at Palm (mm)= Min 0.05minThickness at Finger Tip (mm)= Min 0.05min | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Physical properties | After Aging at 70°C for168 hrs @ 100°C for 22 hrs | Meets ASTM D6319-10 | |
| Tensile Strength (MPa)= Min 14minUltimate Elongation (%)= Min 400min |
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ECO Medi ( (815262-D)
(formerly known as Sinetimed ( umables S
Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999
APPENDIX 2 510K#:141579
| Freedom from pinholes | AQL 2.5Inspection Level G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
|---|---|---|---|
| Residual Powder | $\leq$ 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Biological Evaluation onMedical Device -Primary Skin IrritationTest . | Test Article was non irritant. | Under the conditions ofthis study, the test articlewas a non-irritant . | Under the conditions ofthis study, the test articlewas a non-irritant . |
| Biological Evaluation onMedical Device-Dermal SensitizationAssay . | Test Article was nonsensitizer. | Under the conditions ofthis study, the test articlewas a non-sensitizer. | Under the conditions ofthis study, the test articlewas a non-sensitizer. |
9.0 Conclusion
It can be concluded that EMG Black Nitrile Medical Examination Gloves Powder Free
and predicate devices are substantially equivalent base on intended uses, physical
properties, technological characteristics and non-clinical performance .
Section 2A-5
§ 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.