(262 days)
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner
Blue Nitrile Examination gloves powder free with Peppermint Scented , 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, Blue color, Powder free and non sterile.
The provided document is an FDA 510(k) Premarket Notification for a medical device: "EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented." This document focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than proving superiority or conducting complex clinical studies for a novel AI/software device.
Therefore, the specific information requested about acceptance criteria for AI/software, multi-reader studies, ground truth establishment for training sets, etc., as typically applied to AI/ML medical devices, is not applicable to this submission for examination gloves.
However, I can extract and present the acceptance criteria and performance data for the examination gloves as presented in the document, which are primarily based on physical properties and biocompatibility testing against established ASTM standards.
Here's the information derived from the document, tailored to the context of examination gloves:
Acceptance Criteria and Device Performance for EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented
The device is an examination glove, and its performance is evaluated against established industry standards (primarily ASTM D6319-10 for Nitrile Examination Gloves and ISO 10993-10 for biocompatibility) and compared to a predicate device. The goal of this 510(k) submission is to demonstrate "substantial equivalence" rather than a superior clinical outcome delivered by an AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
The following table summarizes the key performance characteristics and their corresponding acceptance criteria, along with the reported performance of the EMG Powder Free Nitrile Examination Glove. The predicate device's performance is also included for comparative purposes, as the entire submission is based on demonstrating equivalence.
| Characteristic | Acceptance Criteria (Standards/Specifications) | Reported Device Performance (EMG Glove) | Predicate Device Performance (K070097) |
|---|---|---|---|
| General | |||
| Product Code | LZA (Patient Examination Glove) | LZA | LZA |
| 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. | Meets the specified intended use. | Meets the specified intended use. |
| Type of Use | Over-the-counter use. | For over-the-counter use. | For over-the-counter use. |
| Material Use | Not made from Natural Rubber Latex. | Nitrile latex compound. | Nitrile latex compound. |
| Color | Peppermint Scented, blue Color. | Peppermint Scented, blue Color. | Peppermint Scented, blue Color. |
| Sterility | Non-sterile. | Non-sterile. | Non-sterile. |
| Physical Dimensions | (Meets ASTM D6319-10) | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Overall Length (mm) | ≥ 230 min (for all sizes S, M, L, XL) | 230mm min | (Implied to meet ASTM D6319-10) |
| Width (± 5mm) | Size S = 85mm; Size M = 95mm; Size L = 105mm; Size XL = 115mm | S=85, M=95, L=105, XL=115 | (Implied to meet ASTM D6319-10) |
| Thickness at Palm (mm) | ≥ 0.05 min | 0.05mm min | (Implied to meet ASTM D6319-10) |
| Thickness at Finger Tip (mm) | ≥ 0.05 min | 0.05mm min | (Implied to meet ASTM D6319-10) |
| Physical Properties | (Meets ASTM D6319-10) | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Tensile Strength (MPa) - Before Aging | ≥ 14 min | 14 min | (Implied to meet ASTM D6319-10) |
| Ultimate Elongation (%) - Before Aging | ≥ 500 min | 500 min | (Implied to meet ASTM D6319-10) |
| Tensile Strength (MPa) - After Aging (70°C for 168 hrs / 100°C for 22 hrs) | ≥ 14 min | 14 min | (Implied to meet ASTM D6319-10) |
| Ultimate Elongation (%) - After Aging (70°C for 168 hrs / 100°C for 22 hrs) | ≥ 400 min | 400 min | (Implied to meet ASTM D6319-10) |
| Freedom from Pinhole | AQL 2.5 (Inspection Level G-1) (Meets ASTM D5151-06) | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-06 |
| Residual Powder | ≤ 2.0 mg/pc (Meets ASTM D6124-06) | ≤ 2.0 mg/pc | Meets ASTM D6124-06 |
| Biocompatibility | |||
| Primary Skin Irritation Test | Non-irritant per ISO 10993-10. | The test article is a non-irritant per ISO 10993-10. | Under the conditions of this study, the test article was a non-irritant. |
| Dermal Sensitization Assay | Non-sensitizer per ISO 10993-10. | The test article is a non-sensitizer per ISO 10993-10. | 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 exact sample sizes (e.g., number of gloves) for each specific physical and biocompatibility test performed. However, it indicates adherence to ASTM standards (e.g., ASTM D6319-10, ASTM D5151-06, ASTM D6124-06) and ISO 10993-10. These standards specify sampling plans and test methodologies.
- Data Provenance: The tests would have been performed on samples of the manufactured EMG Powder Free Nitrile Examination Glove. The manufacturer, Eco Medi Glove Sdn. Bhd., is based in Malaysia. The testing described is retrospective in the sense that it's performed on finished product samples to demonstrate compliance with standards for market clearance, rather than a clinical trial on patients.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This concept is not applicable to this type of device submission. Examination gloves are physical products evaluated against standardized engineering and biological performance tests, not against interpretations of medical images or other data where expert consensus is needed to establish "ground truth." The "ground truth" is the objective measurement of physical properties (e.g., tensile strength, dimensions, pinholes) and biological responses (e.g., irritation, sensitization) following well-defined test protocols.
4. Adjudication Method for the Test Set
This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, often for medical imaging, to resolve disagreements among reviewers. The testing for examination gloves is based on objective, quantifiable measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids where the impact of the AI on human reader performance is evaluated. For examination gloves, the safety and effectiveness are tied to their physical properties and biocompatibility, not to how they might assist human interpretation of data.
6. If a Standalone (Algorithm Only) Performance Study was Done
No, a standalone performance study (algorithm only) was not done. This submission is for a physical medical device (examination gloves), not an artificial intelligence algorithm.
7. The Type of Ground Truth Used
The "ground truth" for examination gloves is established through adherence to recognized industry standards and laboratory testing protocols. This includes:
- Engineering/Physical Standards: ASTM D6319-10 for physical characteristics (dimensions, tensile strength, elongation), ASTM D5151-06 for pinhole levels, and ASTM D6124-06 for residual powder.
- Biocompatibility Standards: ISO 10993-10 for primary skin irritation and dermal sensitization.
The "ground truth" is the objective measurement result from these standardized tests, which is then compared against the predetermined acceptance criteria within the standards.
8. The Sample Size for the Training Set
This concept is not applicable. This device is not an AI/ML algorithm that requires a "training set." The product is manufactured and then tested to ensure it meets pre-defined specifications.
9. How the Ground Truth for the Training Set was Established
This concept is not applicable as there is no "training set" for this physical device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2016
Eco Medi Glove Sdn. Bhd. Mr. Suresh Kumar Official Correspondent Lot 23826. Jalan Tembaga Kuning. Kamunting Raya Industrial Estate Taiping Perak, 34600 MALAYSIA
Re: K152937
Trade/Device Name: EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 2, 2016 Received: May 13, 2016
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. Isting 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.
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152937
Device Name
EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint scented
Indications for Use (Describe)
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands 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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ECO Medi Glove Sdn
ables merly known as Sinetimed
t 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. L +60-5-891 2777 FAX +60-5-891 2999
510(K) Summary EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented.
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 : 2nd June 2016 .
3.0 Name of the Device
Trade Name / Proprietary Name : EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented
Device Name : Nitrile Patient Examination gloves .
Device Classification Name : Patient Examination gloves (21 CFR 880.6250).
Device Class : Class I .
Product Code : LZA .
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ECO Medi Glove Sdn. Bhd. (815262-D)
(formerly known as Sinetimed Consumables Sdn. Bhd.)
t 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999
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 K070097.Powder Free Nitrile Examination Glove, Peppermint Scented , blue Color
5.0 Description of Device :
Blue Nitrile Examination gloves powder free with Peppermint Scented , 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, Blue color, Powder free and non sterile.
6.0 Executive summary :
EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented is a disposable glove made of nitrile latex compound Blue color powder free. This Blue Nitrile Examination Gloves Powder Free with Peppermint Scented 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 .
| 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 |
6.1.1 Specification for Nitrile gloves: 6.1.1.1 Dimension and Thickness of Gloves .
Section 2A-2
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BCO Medi Glo . Bhd. (815262-D)
(formerly known as Sinetimed Consumables Sdn. Bhd.)
23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALA YSIA. +60-5-891 2777
| Measurement | Before Aging | 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 glove is a disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner .
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, Blue color, powder free and non sterile. It is equivalent to K070097,Powder Free Nitrile Examination Glove, Peppermint Scented, blue Color
| Characteristics | Acceptance Criteria | EMG Powder FreeNitrile ExaminationGlove (Blue) withPeppermint Scented | Powder Free NitrileExamination Glove,Peppermint Scented ,blue Color510K#:070097 |
|---|---|---|---|
| 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. | A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner. | A powder free patientexamination glove is adisposable device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. |
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ECO Medi Glove Sdn. Bhd. (815262-D)
(formerly known as Sinetimed Consumables Sdn. Bhd.)
(formerly known as Sinetimed Consumables Sdn. Bhd.)
Lot 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. FAX +60-5-891 2999 TEL +60-5-891 2777
| The device is for over-the-counter use. | The device is for over-the-counter use. | The device is for over-the-counter use. | ||
|---|---|---|---|---|
| Material use | Not made from Natural RubberLatex. | Nitrile latex compound. | Nitrile latex compound. | |
| Colour | Peppermint Scented , blueColor | Peppermint Scented ,blue Color | Peppermint Scented , blueColor | |
| Sterility | Non sterile | Non sterile | Non sterile | |
| 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 | Before AgingTensile Strength(MPa)= Min 14minUltimateElongation (%)= Min 500minAfter Aging at70°C for168 hrs @100°C for 22hrsTensile Strength(MPa)= Min 14minUltimateElongation (%)= Min 400min | Meets ASTM D6319-10 | Meets ASTM D6319-10 | |
| Freedom from pinholes | AQL 2.5Inspection LevelG-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 MedicalDevice -Primary Skin IrritationTest . | The test articleis a non-irritantper ISO 10993-10. | Under the conditions ofthis study, the test articlewas a non-irritant. | Under the conditions of thisstudy, the test article was a non-irritant. | |
| Biological Evaluation on MedicalDevice-Dermal Sensitization Assay . | The test articleis a non-sensitizer perISO 10993-10. | Under the conditions ofthis study, the test articlewas a non-sensitizer. | Under the conditions of thisstudy, the test article was a non-sensitizer. |
Section 2A-4
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ECO Medi Glove Sdn. Bhd. (815262-D)
(formerly known as Sinetimed Consumables Sdn. Bhd.)
(formerly known as Sinetimed Consumables Sdn. Bhd.)
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
Section 2A-5
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ECO Medi Glove Sdn. Bhd. (815262-D)
(formerly known as Sinetimed Consumables Sdn. Bhd.
Lot 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALA YSIA. TEL +60-5-891 2777 FAX +60-5-891 2999
9.0) Substantial Equivalent Based on Assessment of Non-Clinical Performance data
Performance testing was completed in accordance with ASTM D6319-10 , ASTM D5151-06, and ASTM D6124-06. The glove meet standards requirement referenced in section 6.0 above. Biocompatibility testing per ISO 10993-10:2010 indicates that the subject gloves are non-sensitizing and non-irritating under the conditions tested
9.0 Conclusion
The conclusions drawn from the nonclinical and clinical tests demonstrate that EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented is as safe, as effective, and performs as well as the legally marketed predicate device K070097 Powder Free Nitrile Examination Glove, Peppermint Scented, Blue Color
§ 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.