(82 days)
A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Blue 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,Blue colour, powder free and non sterile.
The provided document describes the acceptance criteria and performance of the "EMG Blue Nitrile Medical Examination Gloves Powder Free (Non Sterile)". This is a medical device for patient examination, not an AI or software device. Therefore, many of the requested categories in the prompt, such as those related to AI algorithm performance, human expert involvement, and ground truth establishment, are not applicable.
Here's an analysis of the provided information, focusing on the relevant sections for a medical device:
1. A table of acceptance criteria and the reported device performance
The document provides a detailed comparison table on page 5, which is further summarized on page 7-8.
| Characteristics / Acceptance Criteria | Reported Device Performance (EMG Blue Nitrile Medical Examination Gloves Powder Free) |
|---|---|
| Product CodeLZA | LZA |
| Intended useA 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 useNot made from Natural Rubber Latex | Nitrile latex compound |
| ColourBlue | Blue |
| SterilityNon sterile | Non sterile |
| Dimensions (Meets ASTM D6319-10)- Overall Length (mm): ≥ 230mm- Width (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm- Thickness at Palm (mm): ≥ 0.05min- Thickness at Finger Tip (mm): ≥ 0.05min | Meets ASTM D6319-10 (Pages 5 and 7 state "Meets ASTM D6319-10" for dimensions) |
| Physical properties (Before Ageing - Meets ASTM D6319-10)- Tensile Strength (MPa): ≥ 14min- Ultimate Elongation (%): ≥ 500min | Meets ASTM D6319-10 (Pages 5 and 7 state "Meets ASTM D6319-10" for physical properties before ageing) |
| Physical properties (After Ageing at 70℃ for 168 hrs @ 100ºC for 22 hrs - Meets ASTM D6319-10)- Tensile Strength (MPa): ≥ 14min- Ultimate Elongation (%): ≥ 400min | Meets ASTM D6319-10 (Pages 5 and 7 state "Meets ASTM D6319-10" for physical properties after ageing) The table on page 5 specifically says "Meets ASTM D6319-10" for the proposed device, and also for the predicate (K 112928) physical properties after aging, implying similarity and compliance. Page 7 confirms the proposed device meets ASTM D6319-10 for physical properties. |
| Freedom from pinholesAQL 2.5, Inspection Level G-1 (Meets ASTM D6319-10) | Meets ASTM D6319-10 (Page 5: "Meets ASTM D6319-10"; Page 8: "Specification within ASTM D6319-10") |
| Residual Powder< 2.0 mg/pc (Meets ASTM D6319-10) | Meets ASTM D6319-10 (Page 5: "Meets ASTM D6319-10"; Page 8: "Specification within ASTM D6319-10") |
| Biocompatibility test- Primary Skin Irritation Test (Consumer Product Safety Commission, Title 16, Chapter II, Part 1500)- Dermal Sensitization Assay (ISO 10993-10:2010(E)) | Under the conditions of thestudy, not an irritant andUnder conditions of thestudy , not asensitizer (Page 5 and Page 8 show the same result for both tests for the proposed device, meeting the implicit criteria of not being an irritant or sensitizer). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that the gloves are manufactured in Malaysia by Eco Medi Glove SDN BHD. However, it does not explicitly mention the sample size used for the tests or the specific provenance of the data generated from these tests (e.g., retrospective or prospective data from a specific country). The tests refer to compliance with ASTM and ISO standards, which would imply that testing was performed according to the methods outlined in those standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to a medical examination glove. "Ground truth" in the context of diagnostic AI refers to the confirmed diagnosis or condition, usually established by medical experts or pathology. For a physical device like a glove, the "ground truth" is adherence to established engineering and medical device standards (ASTM, ISO), which is verified through laboratory testing. No medical experts are involved in establishing the "ground truth" for glove characteristics like tensile strength or pinhole presence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like '2+1' or '3+1' are used for resolving discrepancies in expert opinions during the establishment of ground truth for diagnostic studies, particularly in AI/ML performance evaluation. This is not relevant for the physical testing of a medical glove.
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. An MRMC study involves human readers (e.g., radiologists) interpreting cases, often with and without AI assistance, to measure the AI's impact on their performance. This is irrelevant for a physical medical glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention, which is a concept for AI/software devices. This document is for a physical medical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is its adherence to universally accepted medical device standards and specifications, specifically ASTM D6319-10 for Nitrile Examination Gloves, and biocompatibility standards like Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 for Primary Skin Irritation Test, and ISO 10993-10:2010(E) for Dermal Sensitization Assay. Compliance with these standards is verified through objective physical and chemical laboratory tests.
8. The sample size for the training set
Not applicable. "Training set" refers to data used to train an AI/machine learning model. This is a physical medical device, not an AI.
9. How the ground truth for the training set was established
Not applicable. As explained above, this is a physical medical device, not an AI.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 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 34600 MALAYSIA
Re: K141590
Trade/Device Name: EMG Blue Nitrile Medical Examination Glove Powder Free (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 08, 2014 Received: August 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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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 vou 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/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 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 Device Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K141590
Device Name
EMG Blue Nitrile Medical Examination Gloves Powder Free (Non Sterile)
Indications for Use (Describe)
A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers 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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510(K) Summary EMG Blue Nitrile Medical Examination Gloves Powder Free (Non Sterile)
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 : 22nd August 2014
3.0 Name of the Device
Trade Name / Proprietary Name : EMG Blue Nitrile Medical Examination Gloves Powder Free (Non Sterile)
Device Name : Nitrile Patient Examination gloves
Device Classification Name : Patient Examination gloves (21 CFR 880.6250)
Device Class : Class I
Product Code : Nitrile-LZA
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 K
100603, RS Safe Blue Nitrile Medical Examination Gloves Powder Free ( Non-
Sterile )
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5.0 Description of Device
Blue 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,Blue colour, powder free and non sterile.
6.0 Intended use of the Device
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. It is for over-the-counter use.
7.0 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 colour, powder free and non sterile. It is equivalent to K 100603, RS Safe Blue Nitrile Medical Examination Gloves Powder Free ( Non-Sterile )
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| Characteristics | Acceptance Criteria | EMG Blue NitrileMedical ExaminationGloves( Powder Free) | RS Blue Nitrile MedicalExamination GlovesPowder Free( Non-Sterile ) K 112928 |
|---|---|---|---|
| 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-counteruse.Intended 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. |
| Material use | Not made from Natural RubberLatex | Nitrile latex compound | Nitrile latex compound |
| Colour | Blue | Blue | Blue |
| Sterility | Non sterile | Non sterile | Non sterile |
| Dimensions | Overall Length (mm)= 230mmWidth (± 5mm)Size S = 85mmSize M = 95mmSize L = 105mmSize XL = 115mmThickness at Palm (mm)= 0.05minThickness at Finger Tip (mm)= 0.05min | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Before Ageing | |||
| Tensile Strength (MPa)= 14min | |||
| Ultimate Elongation (%)= 500min | |||
| Physical properties | After Aging at 70℃ for168 hrs @ 100ºC for 22 hrs | Meets ASTM D6319-10 | |
| Tensile Strength (MPa)= 14min | Meets ASTM D6319-10 | ||
| Ultimate Elongation (%)= 400min | |||
| Freedom from pinholes | AQL 2.5Inspection Level G-1 | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Residual Powder | < 2.0 mg/pc | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Biocompatability test-Primary Skin IrritationTest | Under the conditions ofthe study, not an irritantand Under conditions ofthe study , not asensitizer | Under the conditions of thestudy, not an irritant andUnder conditions of thestudy , not a sensitizer | |
| Dermal SensitizationAssay | Under the conditions ofthe study, not an irritantand Under conditions ofthe study , not asensitizer | Under the conditions of thestudy, not an irritant andUnder conditions of thestudy , not a sensitizer |
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EMG Blue Nitrile Medical Examination Gloves Powder Free posting the following technological characteristics
compared to ASTM or Equivalent standards:
| Acceptance Criteria | Standards | Device PerformanceEMG Blue Nitrile MedicalExamination GlovesPowder Free( Non-Sterile ) |
|---|---|---|
| DimensionOverall Length (mm)= 230mmWidth (± 5mm)Size S = 85mmSize M = 95mmSize L = 105mmSize XL = 115mmThickness at Palm (mm)= 0.05minThickness at Finger Tip (mm)= 0.05min Dimension | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Before AgeingTensile Strength (MPa)= 14minUltimate Elongation (%)= 500minAfter Aging at 70°C for168 hrs @ 100°C for 22hrsTensile Strength (MPa)= 14minUltimate Elongation (%)= 400min | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
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| Freedom from pinholeAQL 2.5Inspection Level G-1 | ASTM D 6319-10 | Specification within ASTMD6319-10 |
|---|---|---|
| Residual Powder$≤$ 2.0 mg/pc | ASTM D 6319-10 | Specification within ASTMD6319-10 |
| Biocompatability | Primary Skin Irritation TestConsumer Product SafetyCommission, Title 16,Chapter II, Part 1500 | Under the conditions of thestudy, not an irritant andUnder conditions of thestudy , not a sensitizer |
| Dermal SensitizationAssay-ISO 10993-10:2010(E) | Under the conditions of thestudy, not an irritant andUnder conditions of thestudy , not a sensitizer |
8.0 Conclusion
The Conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally Marketed 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.