(163 days)
Disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile Examination Gloves Powder Free (Blue) are available in blue color. The proposed device is single use, non-sterile, ambidextrous and meets all the requirements of ASTM Specification D6319-10 (2015) — Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Nitrile Examination Gloves Powder Free (Blue) product (K210868).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (and Standard) | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM D6319-10 (Reapproved 2015) | Determine length of the gloves | Length ≥ 230 mm for all sizes | Pass |
| ASTM D6319-10 (Reapproved 2015) | Determine width of the gloves | Size S – 85 ± 5 mm Size M – 95 ± 5 mm Size L – 105 ± 5 mm Size XL – 115 ± 5 mm | Pass |
| ASTM D6319-10 (Reapproved 2015) | Determine thickness of the gloves | Finger ≥ 0.05 mm Palm ≥ 0.05 mm for all sizes | Pass |
| ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves) | Determine holes in the gloves | Accept: 5 out of 125 pieces sample size | Pass |
| ASTM D6124-06 (Reapproved 2017, Standard Test Method for Residual Powder on Medical Gloves) | Determine residual powder in the gloves | ≤ 2 mg/glove | Pass (0.70 mg/glove) |
| ASTM D6319-10 (Reapproved 2015) | Determine physical properties - Tensile strength | Before aging ≥ 14 MPa After aging ≥ 14 MPa | Before aging: Average: 24.83 MPa, Median: 24.90 MPa After aging: Average: 26.23 MPa, Median: 25.95 MPa |
| ASTM D6319-10 (Reapproved 2015) | Determine physical properties - Ultimate Elongation | Before aging ≥ 500 % After aging ≥ 400 % | Before aging: Average: 509.23 %, Median: 500 % After aging: Average: 436.92 %, Median: 440 % |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Holes in Medical Gloves (ASTM D5151-19): An acceptance criterion of "5 out of 125 pieces sample size" is specified, implying a sample size of 125 pieces was used for this test.
- Sample Size for Residual Powder (ASTM D6124-06): While the acceptance criterion is ≤ 2 mg/glove, the specific sample size used for this test is not explicitly stated, only that the result was 0.70 mg/glove.
- Sample Size for other tests (Length, Width, Thickness, Physical Properties): The specific sample sizes for these tests are not explicitly mentioned in the provided text.
- Data Provenance: The studies were non-clinical performance tests conducted by Great Eco Glove Sdn. Bhd., a company located in Malaysia. The type of data is laboratory test results. The document does not specify if the data is retrospective or prospective, but given it's for a 510(k) submission, it would reflect tests performed on batches of the actual device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this device (nitrile examination gloves) relies on standardized objective measurements and chemical/physical properties as defined by ASTM and ISO standards, not expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements and adherence to specified ranges or limits outlined in the standards, rather than subjective interpretation requiring adjudication.
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 device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. As stated above, this device is a medical glove and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device is based on established industry standards and objective measurements. Specifically, the adherence to physical characteristics (length, width, thickness, tensile strength, ultimate elongation), absence of holes, and residual powder content are verified against the requirements set by:
- ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility)
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. It is a physical product whose performance is evaluated through non-clinical laboratory testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device. The "ground truth" for the device's performance is defined by the technical specifications and limits set forth in the aforementioned ASTM and ISO regulatory standards.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 2, 2021
Great Eco Glove Sdn. Bhd. Soh Li QA/OC Manager Lot 1675, Jalan Makmur, Batu 28, Ijok Bestari Jaya, Selangor 45600 Malaysia
Re: K210868
Trade/Device Name: Nitrile Examination Gloves Powder Free (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 6, 2021 Received: August 6, 2021
Dear Soh Li:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Liqun Zhao -S
For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K210868
Device Name
Nitrile Examination Gloves Powder Free (Blue)
Indications for Use (Describe)
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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for GREAT ECO GLOVE SDN BHD (970327-V). The logo consists of a stylized globe on the left, with the company name in red and green text to the right of the globe. The company registration number is in parentheses after the company name.
1.0 510(k) Summary – K210868
| 1.1 Submitter: | |
|---|---|
| Name: | Great Eco Glove Sdn. Bhd. |
| Address: | Lot 1675, Jalan Makmur, Batu 28, Ijok, |
| 45600, Bestari Jaya, Selangor, Malaysia. | |
| Contact: | +603-3279 2199 / +603-3279 3633 |
| 1.2 Contact Person: | |
| Name: | Dr. Neoh Vee Heng (Executive Chairman) |
| Email: | drneoh.geg@gmail.com |
| Name: | Mr. Ian Neoh Puay Guan (Assistant General Manager) |
| Email: | iannpg.geg@gmail.com |
| Name: | Ms. Shahnaz Sakinah Binti Shaiful Bahri (QA/QC Executive) |
| Email: | qaqc.geg@gmail.com |
| Date of summary prepared: | 23rd December 2020 |
| 1.3 Name of Device: | |
| Trade Name: | Nitrile Examination Gloves Powder Free (Blue) |
| Common Name: | Patient Examination Glove |
| Classification Name: | Patient Examination Glove |
| Classification Regulation: | 21 CFR 880.6250 |
Device Class: l Product Code: LZA Classification Panel: General Hospital
Legally Marketed Predicate Device: 1.4
| Predicate Device | |
|---|---|
| Manufacturer | Central Medicare Sdn. Bhd. |
| Trade Name | Orange Non Sterile Powder FreeNitrile Examination Gloves |
| 510 (k) Number | K172642 |
| Product Code | LZA |
| ClassificationRegulation | 21 CFR 880.6250 |
| Device Class | I |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for GREAT ECO GLOVE SDN BHD. The logo features a stylized globe on the left, with the company name in red and green text to the right of the globe. The registration number (970327-V) is in smaller text to the right of the company name.
Device Description: 1.5
Nitrile Examination Gloves Powder Free (Blue) are available in blue color. The proposed device is single use, non-sterile, ambidextrous and meets all the requirements of ASTM Specification D6319-10 (2015) — Standard Specification for Nitrile Examination Gloves for Medical Application.
1.6 Intended Use:
Nitrile Examination Gloves Powder Free (Blue) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
Technological Characteristics: 1.7
Nitrile Examination Gloves Powder Free (Blue) have either similar or the same technological characteristics as compared to the legally marketed predicated device, K172642, Orange Non Sterile Powder Free Nitrile Examination Gloves:
| Characteristics | Standards | Proposed Device:K210868 | Predicate Device:K172642 | Comparison |
|---|---|---|---|---|
| General | ||||
| Manufacturer | N/A | Great Eco Glove Sdn.Bhd. | Central Medicare Sdn.Bhd. | N/A |
| Trade Name | N/A | Nitrile ExaminationGloves Powder Free(Blue) | Orange Non SterilePowder Free NitrileExamination Gloves | Different |
| Product Code | N/A | LZA | LZA | Same |
| ClassificationRegulation | N/A | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Device Class | N/A | I | I | Same |
| Indicationforuse | N/A | Nitrile ExaminationGloves Powder Free(Blue) is a disposabledevice intended formedical purpose thatis worn on theexaminer's hand orfinger to preventcontaminationbetween examinerand patient. | Orange Non SterilePowder Free NitrileExamination Gloves isa disposable deviceintended for medicalpurposes that is wornon the examiner'shands to preventcontaminationbetween patient andexaminer. | Same |
| MaterialComposition | ASTM D6319-10(2015) | Synthetic nitrilerubber | Synthetic nitrilerubber | Similar |
| Color | N/A | Blue | Orange | Different |
| Design | N/A | Non-sterileSingle usePowder free | Non-sterileSingle usePowder free | Same |
| Ambidextrous | Ambidextrous | |||
| Beaded cuff | Beaded cuff | |||
| Labeling | N/A | Meet FDA'srecommendations | Meet FDA'srecommendations | Similar |
| Performance | ||||
| Length ≥ 230 mm | Length ≥ 230 mm | Similar | ||
| Palm Width: | Palm Width: | Similar | ||
| ASTM D6319-10(2015) | Size S - 85 ± 5 mm | Size S - 80 ± 10 mm | ||
| Size M - 95 ± 5 mm | Size M - 95 ± 10 mm | |||
| Dimension | Size L - 105 ± 5 mmSize XL - 115 ± 5 mm | Size L - 110 ± 10 mmSize XL - 120 ± 10 mm | ||
| Thickness:Finger ≥ 0.05 mmPalm ≥ 0.05 mm | Thickness:Finger ≥ 0.05 mmPalm ≥ 0.05 mm | Similar | ||
| Tensile Strength:Before aging ≥ 15MPaAfter aging ≥ 14 MPa | Tensile Strength:Before aging ≥ 15MPaAfter aging ≥ 14 MPa | Similar | ||
| ASTM D6319-10(2015) | Ultimate Elongation:Before aging ≥ 500 %After aging ≥ 400 % | Ultimate Elongation:Before aging ≥ 500 %After aging ≥ 400 % | Similar | |
| PhysicalProperties | ||||
| ASTM D6319-10(2015)ASTM D5151-19 | Passes or exceedsASTM D6319-10(2015) and ASTMD5151-19requirements of AQL2.5 / Inspection levelG1 | Passes or exceedsASTM D6319-10(2015) and ASTMD5151-19requirements of AQL2.5 / Inspection levelG1 | Similar | |
| Freedom ofHoles | ||||
| PowderContent | ASTM D6319-10(2015)ASTM D6124-06(2011) | ≤ 2 mg/glove | ≤ 2 mg/glove | Similar |
| Biocompatibility | ISO 10993-10:2010 | Primary Skin Irritation:Under conditions ofthe study not anirritant | Primary SkinIrritation: Underconditions of thestudy not an irritant | Similar |
| Dermal Sensitization:Under conditions ofthe study not asensitizer | Dermal Sensitization:Under conditions ofthe study not asensitizer |
{5}------------------------------------------------
GREAT ECO GLOVE SDN BHD (970327-V)
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for GREAT ECO GLOVE SDN BHD. The logo features a green and blue globe graphic on the left. To the right of the graphic is the company name in red and green text, with the registration number (970327-V) in parentheses.
Summary of Non-Clinical Performance Data: 1.8
Test results below demonstrated that the proposed device complies with the following specification and guidance:
- ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. -
- -Guidance for Industry and FDA Staff Medical Glove Guidance Manual (Document issued on January 22, 2008)
The following standards were followed to carry out the testing:
- -ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- -ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves.
- ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
- -ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers -Tension -
- ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves -
- -ASTM D573 - 04 Standard Test Method for Rubber—Deterioration in an Air Oven
{7}------------------------------------------------
GREAT ECO GLOVE SDN BHD (970327-V)
Non-clinical Testing Summary
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-10(Reapproved 2015)Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication | To determinethe length of thegloves | Length ≥ 230 mm for allsizes | Pass |
| ASTM D6319-10(Reapproved 2015)Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication | To determinethe width of thegloves | Size S – 85 ± 5 mmSize M – 95 ± 5 mmSize L – 105 ± 5 mmSize XL – 115 ± 5 mm | Pass |
| ASTM D6319-10(Reapproved 2015)Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication | To determinethe thickness ofthe gloves | Finger ≥ 0.05 mmPalm ≥ 0.05 mm for allsizes | Pass |
| ASTM D5151-19Standard Test Methodfor Detection of Holes inMedical Gloves. | To determinethe holes in thegloves | Accept: 5 out of 125pieces sample size | Pass |
| ASTM D6124-06(Reapproved 2017),Standard Test Methodfor Residual Powder onMedical Gloves. | To determinethe residualpowder in thegloves | ≤ 2 mg/glove | Pass (0.70 mg/glove) |
| ASTMD6319-10(Reapproved 2015)Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication | To determinethe physicalproperties -Tensile strength | Tensile Strength:Before aging ≥ 14 MPaAfter aging ≥ 14 MPa | Before aging,Average: 24.83 MPaMedian: 24.90 MPaAfter aging,Average: 26.23 MPaMedian: 25.95 MPa |
|---|---|---|---|
| To determinethe physicalproperties –UltimateElongation | Ultimate Elongation:Before aging ≥ 500 %After aging ≥ 400 % | Before aging,Average: 509.23 %Median: 500 %After aging,Average: 436.92 %Median: 440 % |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Great Eco Glove SDN BHD. The logo features a stylized globe graphic on the left. The text "GREAT ECO GLOVE SDN BHD" is in red and green, followed by the registration number "(970327-V)" in black.
1.9 Summary of Clinical Performance Data:
Clinical data is not necessary for Class I Patient Examination Glove 510(k) Submissions.
1.10 Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicated device, K172642, Orange Non Sterile Powder Free Nitrile Examination Gloves.
§ 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.