(68 days)
The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential meet ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This document pertains to the 510(k) submission for Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential (K241528).
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions - Thickness | ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application ISO 2859-1/S2/AQL 4.0 Length - Size XS, S, M, L, XL – Min. 230 mm Width - XS - 70±10mm, S – 80±10mm, M – 95±10mm, L – 110±10mm, XL – 120±10mm Thickness at Finger – min. 0.05mm Thickness at Palm – min. 0.05mm | Pass |
| Physical Properties | ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application & ASTM D412-16(2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension Before aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500% After aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400% | Pass |
| Powder Residue | ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves ≤ 2 mg/glove | Pass |
| Freedom from Holes | ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves AQL 1.5 | Pass |
| Irritation | ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation Under the conditions of the study, the device is not an irritant. | Under the conditions of the study, the device was not an irritant. |
| Sensitization | ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization Under the conditions of the study, the device is not a sensitizer. | Under the conditions of the study, the device was not a sensitizer. |
| Cytotoxicity | ISO 10993-5 Biological evaluation of medical devices-Part 5 Tests for in vitro cytotoxicity Under the conditions of the study, the subject device extract does not exhibit cytotoxicity reactivity. | Under the conditions of the study, the subject device extract exhibits cytotoxicity from 100.0% extract concentrations to 50.0% extract concentrations and no cytotoxicity reactivity from 25.0% extract concentrations to 3.125% extract concentrations. (Note: This is a deviation from the acceptance criteria, as the device exhibited cytotoxicity at higher concentrations). |
| Acute systemic toxicity | ISO 10993-11 Biological evaluation on medical device Part 11 - Test for systemic toxicity Under the conditions of this study, the test article does not induce acute systemic toxicity. | Under the conditions of this study, the test article did not induce acute systemic toxicity. |
| Low Dermatitis Potential (Modified Draize) | Modified Draize ASTM 6355-07 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves. No clinical evidence that the glove may induce Type IV allergy in the unsensitized general user population. | There was no clinical evidence that the glove may induce Type IV allergy in the unsensitized general user population. |
2. Sample size used for the test set and the data provenance:
- Physical Dimensions, Physical Properties, Powder Residue, Freedom from Holes: The specific sample sizes are not explicitly stated within the provided text, but the tests were conducted according to ASTM and ISO standards (e.g., ISO 2859-1/S2/AQL 4.0 for dimensions, AQL 1.5 for freedom from holes), which prescribe sampling plans. The data provenance is from non-clinical tests conducted by the manufacturer, Comfort Rubber Gloves Industries Sdn. Bhd. No country of origin for the specific testing labs is provided, nor is it specified if the data is retrospective or prospective, though it's likely prospective for the submission.
- Irritation, Sensitization, Cytotoxicity, Acute systemic toxicity: The specific sample sizes for these biocompatibility tests are not explicitly stated in the document. These tests are likely performed ex vivo or in vivo with animal models (e.g., mice for acute systemic toxicity) or in vitro (e.g., for cytotoxicity). The data provenance is from non-clinical tests conducted by the manufacturer.
- Low Dermatitis Potential (Modified Draize): The specific sample size for the human repeat insult patch test (HRIPT) is not explicitly stated. The Modified Draize test (ASTM 6355-07) is a clinical test involving human subjects, therefore, the data provenance is clinical, likely from a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are primarily laboratory-based or standardized clinical tests with defined acceptance criteria, rather than requiring expert interpretation for ground truth establishment in the traditional sense of medical image analysis or complex diagnostic tasks. The "ground truth" for these tests is the quantitative or qualitative outcome against a standard.
4. Adjudication method for the test set:
Not applicable. The tests performed are objective, standardized tests with predefined acceptance criteria. There is no mention or implication of a need for adjudication by multiple human experts for the results of these physical, chemical, or biological tests.
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 assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical glove, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for most of these tests is based on objective measurements and established standards:
- Physical Properties (Dimensions, Tensile Strength, Elongation, Powder Residue, Freedom from Holes): Ground truth is based on quantitative measurements against the physical requirements specified in ASTM D6319-19, ASTM D412-16(2021), ASTM D6124-06(2022), and ASTM D5151-19.
- Biocompatibility (Irritation, Sensitization, Acute Systemic Toxicity): Ground truth is based on observations and measurements from standardized biological evaluations (ISO 10993 series) against set criteria for biological responses.
- Cytotoxicity: Ground truth is based on observable cellular responses in in vitro tests (ISO 10993-5).
- Low Dermatitis Potential (Modified Draize): Ground truth is based on the absence of clinical evidence of Type IV allergy in human subjects, as observed and reported in the HRIPT study, following ASTM 6355-07. This involves clinical observation in human subjects.
8. The sample size for the training set:
Not applicable. This is a physical medical device (gloves) and not an AI/ML-based algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As this device is a medical glove, it does not involve a training set or associated ground truth establishment for an AI/ML model.
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August 8, 2024
Comfort Rubber Gloves Industries Sdn. Bhd. % Terrell Cunningham Regulatory Consultant T. Cunningham Consulting & Associates, LLC 12812 Meadowbrook LN Waldorf, Maryland 20601
Re: K241528
Trade/Device Name: Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA
Dear Terrell Cunningham:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 6, 2024. Specifically, FDA is updating this SE Letter to correct a typo in the Regulatory Class as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, M.D., Ph.D., OHT4: Office of Surgical and Infection Control Devices, at Bifeng. Qian@fda.hhs.gov.
Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
August 6, 2024
Comfort Rubber Gloves Industries Sdn. Bhd. % Terrell Cunningham Regulatory Consultant T. Cunningham Consulting & Associates, LLC 12812 Meadowbrook LN Waldorf, Maryland 20601
Re: K241528
Trade/Device Name: Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class II Product Code: LZA Dated: April 2, 2024 Received: May 30, 2024
Dear Terrell Cunningham:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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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Additional information about changes that may requre a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4C: Division of Infection Control 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
Submission Number (if known)
Device Name
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
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- K241528
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
1.0 Submitter:
| Name | Comfort Rubber Gloves Industries Sdn. Bhd. |
|---|---|
| Address | Lot 821, Jalan Matang,34750 Matang, Perak, Malaysia.Malaysia. |
| Phone No. | 605-847 2777 |
| Fax No. | 605-847 9108 |
| Contact Person: | Sumathi d/o Sararavan Sami (Miss.) |
Date of Preparation: 1st August 2024
2.0 Name of the Device
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
Common Name: Patient Examination Gloves
Classification Name: Patient Examination Gloves (21 CFR 880.6250)
Class: I
Product Code: LZA
3.0 Predicate Device
Device Name: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Company: Hartalega SDN. BHD 510(k) No.: K162646
Common Name: Patient Examination Gloves
Classification Name: Patient Examination Gloves (21 CFR 880.6250)
Class: I
Product Code: LZA
4.0 Description of the Device:
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential meet ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
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5.0 Indication for Use of the Device
The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
6.0 Summary of the Technological Characteristics of the Device:
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential and predicate, K162646 are summarized with the following technological characteristics. Both gloves are made with nitrile and meets ASTM D6319-19 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.
| CHARACTERISTIC | PREDICATEDEVICEK162646 | SUBJECTDEVICEK241528 | COMPARISON |
|---|---|---|---|
| Manufacturer(s) | HartalegaSDN. BHD | ComfortRubberGlovesIndustriesSdn. Bhd | Different |
| Device Name | Nitrile PowderFreeExaminationGlove, Non-Sterile LowDermatitisPotential (Blue) | Nitrile PowderFreeExaminationGloves (Blue),Non-SterileLowDermatitisPotential | Similar |
| Indications for Use | The NitrilePowder FreeExaminationGlove, Non-Sterile LowDermatitis(Blue)Potential is amedical glovewhich is adisposabledeviceintended formedicalpurposes thatis worn on theexaminer'shand or fingerto preventcontaminationbetweenexaminer andpatient. | The NitrilePowder FreeExaminationGloves(Blue), Non-Sterile LowDermatitisPotential is amedical glovewhich is adisposabledeviceintended formedicalpurposes thatis worn on theexaminer'shand or fingerto preventcontaminationbetweenexaminer andpatient. | Similar |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| CHARACTERISTIC | PREDICATE DEVICE K162646 | SUBJECT DEVICE | COMPARISON |
| Size | XS, S, M, L, XL | XS, S, M, L, XL | Same |
| Dimensions | Meets ASTM D6319-10Thickness at Finger - min. 0.05mmThickness at Palm - min. 0.05mmLength - Min. 230 mmWidth - M - 95±10mm | Meets ASTM D6319-19Thickness at Finger - min. 0.05mmThickness at Palm - min. 0.05mmLength - Size XS, S, M, L, XL - Min. 230Width - XS- 70±10mm S- 80±10mm M- 95±10mm L- | Similar |
| Physical Properties | Meets ASTM D6319-10.Tensile Strength:Before AgingMin. 14 MPaUltimate Elongation:Before Agingmin. 500% | Meets ASTM D6319-19.TensileBefore AgingMin. 14 MPaUltimate ElongationBefore Agingmin. 500% | Same |
| After AgingMin. 14 MPaAfter Agingmin. 400% | After AgingMin. 14 MPaAfter Agingmin. 400% | ||
| Powder Content | Meets ASTM 6124-06 (2011)(≤ 2 mg/glove) | Meets ASTM 6124-06 (2022)(≤ 2 mg/glove) | Same |
| Freedom from Holes | Meets ASTM D5151-06. | Meets ASTM D5151-19. | Same |
| CHARACTERISTIC | PREDICATEDEVICEK162646 | SUBJECTDEVICEK241528 | COMPARISON |
| Low DermatitisPotential | Meets ModifiedDraize ASTM6355-07Standard TestMethod for HumanRepeat Insult PatchTesting of MedicalGloves. | Meets ModifiedDraize ASTM6355-07Standard TestMethod for HumanRepeat Insult PatchTesting of MedicalGloves. | Same |
| Biocompatibility:Irritation Tests | Under the conditionsof the study, thesubject device is non-irritating. | Under the conditionsof the study, thesubject device is non-irritating. | Same |
| Biocompatibility:SkinSensitization Tests | Under the conditionsof the study, thesubject device is notsensitizing. | Under the conditionsof the study, thesubject device is notsensitizing. | Same |
| Biocompatibility:Cytotoxicity | No test report wassubmitted for thepredicate. | Under the conditionsof the study, thesubject device extractexhibits mild | Different |
| Biocompatibility:Acute systemic Toxicity | No test report wassubmitted for thepredicate. | Did not induce anyacute systemic toxicityin swiss albino miceunder the conditionsof the study. | Different |
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8.0 Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|
| Physical DimensionsThickness | ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplication | ISO 2859-1/S2/AQL 4.0Length -Size XS, S, M, L, XL –Min. 230Width -XS - 70±10mm S –80±10mmM – 95±10mmL – 110±10mmXL – 120±10mmThickness at Finger –min. 0.05mmThickness at Palm –min. 0.05mm | Pass |
| Physical Properties | ASTM D6319-19Standard Specificationfor Nitrile ExaminationGloves for MedicalApplicationASTM D412-16(2021)Standard Test Methodsfor Vulcanized Rubberand ThermoplasticElastomers-Tension | Before aging:Tensile Strength: ≥14MPaUltimate elongation:≥500%After aging:Tensile Strength: ≥14MPaUltimate elongation:≥400% | Pass |
| Powder Residue | ASTM D6124-06(2022)Standard Test Methodfor Residual Powder onMedical Gloves | ≤ 2 mg/glove | Pass |
| Freedom from Holes | ASTM D5151-19Standard Test Methodfor Detection of Holes inMedical Gloves | AQL 1.5 | Pass |
| Irritation | ISO 10993-23:2021Biological evaluation ofmedical devices Part 23:Tests for irritation | Under the conditions of thestudy, the device is not anirritant. | Under the conditions of thestudy, the device was notan irritant. |
| Sensitization | ISO 10993-10:2021Biological evaluation ofmedical devices Part 10:Tests for skinsensitization | Under the conditions of thestudy, the device is not asensitizer. | Under the conditions ofthe study, the devicewas not a sensitizer. |
| Cytotoxicity | ISO 10993-5 Biologicalevaluation of medicaldevices-Part 5 Tests forin vitro cytotoxicity | Under the conditions ofthe study, the subjectdevice extract does notexhibit cytotoxicityreactivity. | Under the conditions ofthe study, the subjectdevice extract exhibitscytotoxicity from 100.0 %extract concentrations to50.0 % extractconcentrations andno cytotoxicity reactivityfrom 25.0 % extractconcentrations to 3.125% extractconcentrations. |
| Acute systemic toxicity | ISO 10993-11 Biologicalevaluation on medicaldevice Part 11 - Test forsystemic toxicity | Under the conditions ofthis study, the test articledoes not induce acutesystemic toxicity. | Under the conditions ofthis study, the test articledid not induce acutesystemic toxicity. |
| Low Dermatitis Potential | Modified DraizeASTM 6355-07Standard Test Methodfor Human Repeat InsultPatch Testing of MedicalGloves. | No clinical evidence thatthe glove may induceType IV allergy in theunsensitized generaluser population. | There was no clinicalevidence that the glovemay induce Type IVallergy in theunsensitized generaluser population. |
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9.0 Clinical Performance Data
Clinical data is not needed.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate 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.