(82 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free synthetic Nitrile patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.
The document describes the Edma Synthetic Nitrile Examination Gloves (K211540) and their acceptance criteria through non-clinical testing.
Here's the breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions | Length: ≥230mm; Width (M: 95±10, L: 110±10, XL: 120±10); Thickness (Finger: ≥0.08mm, Palm: ≥0.08mm) | Length: >230mm; Width (M: 96-99, L: 106-109, XL: 114-118); Thickness (Finger: 0.08-0.13mm, Palm: 0.08-0.09mm). Pass |
| ASTM D5151 | Watertightness | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks. Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.07 mg. Pass |
| ASTM D412 | Physical properties | Before Aging Tensile Strength ≥14MPa; Ultimate Elongation ≥500% | Tensile Strength: 15-18.5MPa. Pass; Ultimate Elongation: 506-576%. Pass |
| ASTM D412 | Physical properties | After Aging Tensile Strength ≥14MPa; Ultimate Elongation ≥400% | Tensile Strength: 14-17.6MPa. Pass; Ultimate Elongation: 400-522%. Pass |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. Pass. |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. Pass. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Watertightness Test (Detection of Holes): 125 (0/125 leaks reported). No specific sample sizes for other tests were explicitly stated within the document.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The applicant is Edma Group, LLC, based in Phoenix, AZ, USA. The designated submission correspondent is Shanghai Truthful Information Technology Co., Ltd., based in Shanghai, China. This suggests testing could have been conducted in either location or by a third-party laboratory.
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 information is not applicable as the document describes the testing of a medical device (examination gloves) based on established international and national standards (ASTM, ISO). The "ground truth" here is compliance with these standards, measured through physical and biological tests, not through expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable to this type of device testing. Adjudication methods are typically used in studies involving human interpretation (e.g., imaging studies) to resolve discrepancies among experts. The tests performed are objective laboratory measurements.
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:
This information is not applicable. This document evaluates physical characteristics and biocompatibility of examination gloves, not an AI-powered diagnostic device or a system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is an examination glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is compliance with established national and international standards and specifications (ASTM D6319, ASTM D6124, ASTM D5151, ISO 10993-5, ISO 10993-10). These standards define objective criteria (e.g., minimum tensile strength, maximum powder content, absence of holes, non-cytotoxicity) that the device must meet.
8. The sample size for the training set:
This information is not applicable. The device is an examination glove, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 9, 2021
Edma Group, LLC % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161, Lujiazui East Rd., Pudong Shanghai, 200120 China
Re: K211540
Trade/Device Name: Edma Synthetic Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 12, 2021 Received: May 19, 2021
Dear Boyle Wang:
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.
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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 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 (QS) 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.
For Clarence W. Murray III, Ph.D. 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
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Indications for Use
510(k) Number (if known) K211540
Device Name
Edma Synthetic Nitrile Examination Gloves
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (K211540)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Edma Group, LLC. Name: Address: 3634 E Piccadilly Rd, Phoenix, AZ 85018. Contact: Mr. Vio Cretu Date of Preparation: 07/03/2021
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Edma Synthetic Nitrile Examination Gloves Common name: Patient Examination Glove Classification name: Non-powdered patient examination glove Model(s): M. L. XL
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Careglove Global Sdn Bhd Device: Powder Free Nitrile Examination Gloves, Blue (colored) 510(k) number: K172015
5.0 Indication for Use
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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.
6.0 Device Description
The subject device is powder free synthetic Nitrile patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.
| Item | Subject device | Predicate device | Comparison |
|---|---|---|---|
| 510(k) number | K211540 | K172015 | -- |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner. | A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner. | Same |
| Powdered orPowered free | Powdered free | Powdered free | Same |
| Main Material | Nitrile | Nitrile | Same |
| Colorant | Blue | Blue | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Single Use | Yes | Yes | Same |
| Sterility status | Non-Sterile | Non-Sterile | Same |
| Dimensions(mm) | Length:≥230;Width:M:95±10;L:110±10;XL:120±10; | Length:XS/S:≥220;M/L/XL: ≥230;Width:XS:70±10;S:80±10;M:95±10;L:110±10;XL:120±10; | Similar |
| Physical | Before Tensile 14MPa min | Tensile 14MPa min | Same |
7.0 Technological Characteristic Comparison Table
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| Properties | Aging | Strength | Strength | ||||
|---|---|---|---|---|---|---|---|
| UltimateElongation | 500%min | UltimateElongation | 500%min | Same | |||
| AfterAging | TensileStrength | 14MPa,min | TensileStrength | 14MPa,min | Same | ||
| UltimateElongation | 400%min | UltimateElongation | 400%min | Same | |||
| FreedomfromHoles | Be free from holes whentested in accordancewith ASTM | Meet AQL 1.5Meet AQL 2.5 | Same | ||||
| AQL=2.5 | D5151 | ||||||
| Powder Content | <0.07 mg per glove.Meet the requirementsof ASTM D6124 | Meet 2mg/glove max.Meet the requirementsof ASTM D6124 | Same | ||||
| Biocompatibility | Irritation: Under theconditions of the study,not an irritant or asensitizer. | Under the conditions ofthis study the testmaterial did not cause anirritant response. | |||||
| Sensitization: Underconditions of the study,not a sensitizer. | Under the conditions ofthis study,the testmaterial did not producea skin sensitization effect | Same | |||||
| Cytotoxicity: Underconditions of the study,did not show potentialtoxicity to L-929 cells. | / | ||||||
| LabelingInformation | Single use, powder free,device color, devicename, glove size andquantity, Non-Sterile | Single use, powder free,device color, devicename, glove size andquantity, Non-Sterile | Same |
8.0 Summary of Non-clinical Testing
Non clinical tests were conducted to verify that the subject device met all
design specifications as was Substantially Equivalent (SE) to the predicate
device. The subject device were evaluated according to the following standards:
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
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ASTMD5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
Biocompatibility Testing:
The biocompatibility evaluation for the subject device were evaluated
according to the following standard:
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Biocompatibility testing including cytotoxicity test, sensitization test and irritation test according to ISO 10993-1 standards, have been conducted on the Edma Synthetic Nitrile Examination Gloves.
Under the parameters of the tests it is concluded that they are biocompatible, and that there are no new issues of biocompatibility regarding their use as intended.
| TestMethodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | PhysicalDimensionsTest | Length(mm):≥230;Width(mm):M: 95±10;L: 110±10;XL: 120±10 | Length: >230Width:M: 96-99L: 106-109XL: 114-118Pass |
| Thickness (mm):Finger: ≥0.08Palm: ≥0.08 | Finger: 0.08-0.13Palm: 0.08-0.09Pass | ||
| ASTM D5151 | WatertightnessTest forDetection ofHoles | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaksPass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.07 mgPass |
| ASTM D412 | Physicalproperties | Before TensileAging Strength ≥14MPa | 15-18.5Pass |
Table 2: Performance Characteristic Comparison
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| UltimateElongation | ≥500% | 506-576Pass | ||||
|---|---|---|---|---|---|---|
| AfterAging | TensileStrength | ≥14MPa | 14-17.6Pass | |||
| UltimateElongation | ≥400% | 400-522Pass | ||||
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditionsof the study, didnot show potentialtoxicity to L-929cells.Pass | |||
| ISO 10993-10 | Irritation | Non-irritating | Under theconditions of thestudy, not anirritant.Pass | |||
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditionsof the study, not asensitizer.Pass |
9.0 Summary of Clinical Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device, K211540 is as safe, as effective, and performs as well as or better than the legally marketed predicated 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.