(200 days)
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves are intended for medical purposes that are worn on the examiners hands to prevent contamination between patient and examiner.
The MICRO-TOUCH® DENTA-GLOVE® Nitrile HydraSoft™ are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the glove to make donning easy. Hydrasoft coating (containing glycerine) is applied on top of the polymer coating on the glove inner surface..
Characteristic:
- Ambidextrous with beaded cuff and straight fingers
- Finger-textured,
- White colored
- Featuring inner coating of polyacrylic polymer coating and HydraSoft™ coating.
- . Five (5) sizes – extra-small, small, medium, large, and extra-large.
The provided text describes the acceptance criteria and performance data for a medical device, the "Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves."
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Result Summary) |
|---|---|---|
| Physical Characteristics: | ASTM D6319-10 | Meets ASTM D6319-10 requirements for length, width and thickness |
| Length | Minimum 230mm | Minimum 240mm |
| Palm width (XS) | 70 ± 10 mm | 75 ± 5 mm |
| Palm width (S) | 80 ± 10 mm | 85 ± 5 mm |
| Palm width (M) | 95 ± 10 mm | 95 ± 5 mm |
| Palm width (L) | 110 ± 10 mm | 105 ± 5 mm |
| Palm width (XL) | 120 ± 10 mm | 115 ± 5 mm |
| Thickness (mm) - single-wall | minimum 0.05 mm | |
| Finger | minimum 0.05 mm | 0.11 ± 0.03 mm |
| Palm | minimum 0.05 mm | 0.07 ± 0.02 mm |
| Cuff | N/A (implied by minimum 0.05 for other areas) | 0.06 ± 0.02 mm |
| Physical Properties: | ASTM D6319-10 | Meets ASTM D6319-10 requirements for tensile strength and ultimate elongation before and after accelerated aging |
| Tensile Strength | ||
| Before Aging | minimum 14 MPa | minimum 17 MPa |
| After Aging | minimum 14 MPa | minimum 17 MPa |
| Ultimate Elongation | ||
| Before Aging | minimum 500% | minimum 500% |
| After Aging | minimum 400% | minimum 400% |
| Freedom from holes | ASTM D6319-10, ASTM D5151-06 (AQL 2.5) | Meets ASTM D6319-10 and ASTM D5151-06 requirements of AQL 2.5 |
| Powder Residual | ASTM D6319-10, ASTM D6124-06 (≤ 2 mg per glove) | Meets applicable requirement for powder free; ≤ 2 mg per glove |
| Biocompatibility: | ||
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009 | Under the conditions of the study, undiluted and 1:2 dilution was cytotoxic. 1:4, 1:8, 1:16, 1:32 and 1:64 are not cytotoxic |
| ISO Skin Irritation Study | ISO 10993-10:2010 | Under the conditions of the study, not an irritant |
| ISO Maximization Sensitization Study | ISO 10993-10:2010 | Under the conditions of the study, not a sensitizer |
| ISO acute systemic toxicity | ISO 10993-11: 2006 | Under the conditions of the study, no evidence of systemic toxicity |
2. Sample Size Used for the Test Set and Data Provenance:
The document focuses on non-clinical performance data and refers to established ASTM and ISO standards for testing. Specific sample sizes for each test are not explicitly stated in this summary but would be defined within the referenced ASTM and ISO standards. The data provenance is derived from these standard-compliant tests conducted on the device. No information on country of origin of the data is provided, nor whether it is retrospective or prospective, as these terms typically apply to clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this document. The "ground truth" for evaluating this device's performance is based on established engineering and biocompatibility standards (ASTM and ISO), not expert consensus in a clinical context.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods are typically used in clinical studies involving human readers/interpreters, not for performance testing against established engineering standards like those for examination gloves.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not conducted on the subject or predicate devices." This type of study would involve human readers (e.g., medical professionals) evaluating cases, which is not relevant for this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This information is not applicable given the device is a patient examination glove, not an AI algorithm. The performance evaluation is based on direct physical and chemical testing of the glove itself.
7. The Type of Ground Truth Used:
The "ground truth" for the performance evaluation of the Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves are established international and national standards for medical devices, specifically:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves.
- 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.
- ISO 10993-11:2006: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity.
8. The Sample Size for the Training Set:
This information is not applicable. "Training set" refers to data used to train machine learning algorithms. This device is a physical product, not an AI algorithm, and therefore does not have a "training set" in that context.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 29, 2017
Ansell Healthcare Products LLC Robert Mahler Director, Regulatory Affairs for the Americas 111 Wood Avenue South, Suite 210 Iselin, New Jersey 08830
Re: K171737
Trade/Device Name: Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: December 8, 2017 Received: December 11, 2017
Dear Robert Mahler:
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 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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang
-s
Tina Kiang, Ph.D. Acting 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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Indications for Use
510(k) Number (if known) K171737
Device Name
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Glove
Indications for Use (Describe)
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves are intended for medical purposes that are worn on the examiners hands to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter Use (21 CFR 801 Subnart C) |
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510k Summary
510(k): K171737
Submitter:
Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 USA
Contact Person:
Robert Mahler Director, Regulatory Affairs for the Americas Phone: (732) 345-2174 Email: rob.mahler@ansell.com
Date Prepared:
12/8/2017
Name of the Device:
| Trade Names: | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves | |
|---|---|---|
| Common Name: | Patient Examination Glove | |
| Classification Name: | Patient Examination Glove | |
| Classification Regulation: | 21 CFR 880.6250 | |
| Device Class: | 1 | |
| Product Code: | LZA | |
| Classification Panel: | General and Plastic Surgery | |
| Legally Marketed Predicate Device: | ||
| Company: | Wear Safe (Malaysia) Sdn Bhd | |
| Trade Name: | Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-colored), Non-sterile, Polymer CoatedPowder Free Nitrile Patient Examination Gloves, Blue Colored and white (Non-colored), Non-sterile, without Polymer (Chlorinated) | |
| 510(k) Number: | K123469 | |
| Device Class: | Class I |
| 510(k) Number: | K123469 |
|---|---|
| Device Class: | Class I |
| Product Code: | LZA (Nitrile) |
| Device Name: | Patient Examination Glove (21 CFR 880.6250) |
Reference Device:
| Company: | Ansell Healthcare LLC |
|---|---|
| Trade Name: | Encore Sterile Powder-Free Polymer Coated Latex Surgical Glove with Hydrasoft™Coating (containing glycerine) and Protein Labeling Claim (50mg or less) |
| 510(k) Number: | K051793 |
| Device Class: | Class I |
| Product Code: | KGO |
| Device Name: | Surgeon's Glove (21 CFR 878.4460) |
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Device Description:
The MICRO-TOUCH® DENTA-GLOVE® Nitrile HydraSoft™ are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the glove to make donning easy. Hydrasoft coating (containing glycerine) is applied on top of the polymer coating on the glove inner surface..
Characteristic:
- Ambidextrous with beaded cuff and straight fingers
- Finger-textured,
- White colored
- Featuring inner coating of polyacrylic polymer coating and HydraSoft™ coating.
- . Five (5) sizes – extra-small, small, medium, large, and extra-large.
High levels of ozone will degrade rubber material of the glove, therefore the glove should be protected from ozone in particular.
The gloves are designed to meets the specifications of ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Indications for Use Statement:
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.
Technological Characteristics:
Micro Touch Denta Glove with Hydrasoft Coating Nitrile Patient Examination Gloves have the following technological characteristics as compared to ASTM or equivalent standards:
| Characteristics | Standard/Test/ | Result Summary |
|---|---|---|
| FDA Guidance | ||
| Physical Characteristics : | ||
| Dimensions: | ASTM D6319-10 | Meets ASTM D6319-10 requirements for length, |
| width and thickness | ||
| Length | Minimum 230mm | Minimum 240mm |
| Palm width (mm) | ||
| Size — XS | 70 ± 10 | 75 ± 5 |
| Size — S | 80 ± 10 | 85 + 5 |
| Size — M | 95 ± 10 | 95 + 5 |
| Size — L | 110± 10 | 105 + 5 |
| Size - XL | 120 ± 10 | 115 ± 5 |
| Thickness (mm) - single-wall | ||
| Finger | minimum 0.05 | Finger - 0.11 ± 0.03 |
| Palm | minimum 0.05 | Palm – 0.07 ± 0.02 |
| Cuff | Cuff -- 0.06 ± 0.02 |
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Pre-market Notification: Traditional 510(k) Submission Micro-Touch Denta-Glove with HydraSoft Coating Nitrile Examination Glove
| Physical Properties: | ASTM D6319-10 | Meets ASTM D6319-10 requirements for tensilestrength and ultimate elongation before and afteraccelerated aging: |
|---|---|---|
| Tensile Strength | ||
| Before Aging | minimum 14 MPa | minimum 17 MPa |
| After Aging | minimum 14 MPa | minimum 17 MPa |
| Ultimate Elongation | ||
| Before Aging | minimum 500% | minimum 500% |
| After Aging | minimum 400% | minimum 400% |
| Freedom from holes | ASTM D6319-10ASTM D5151-06 | Meets ASTM D6319-10 and ASTM D5151-06requirements of AQL 2.5 |
| Powder Residual | ASTM D6319-10ASTM D6124-06 | Meets applicable requirement for powder free; ≤2 mg per glove |
| Biocompatibility: | ||
| ISO In VitroCytotoxicity | ISO 10993-5:2009 | Under the conditions of the study, undiluted and1:2 dilution was cytotoxic. 1:4, 1:8, 1:16, 1:32 and1:64 are not cytotoxic |
| ISO Skin IrritationStudy | ISO10993-10:2010 | Under the conditions of the study, not an irritant |
| ISO MaximizationSensitization Study | ISO 10993-10:2010 | Under the conditions of the study, not asensitizer |
| ISO acute systemictoxicity | ISO 10993-11: 2006 | Under the conditions of the study, no evidence ofsystemic toxicity |
Substantial Equivalence:
| Trade name | Predicate Device | Reference Device | Proposed SubjectDevice | SubstantialEquivalence toPredicate |
|---|---|---|---|---|
| Powder Free NitrilePatient ExaminationGlove, Blue Colored,and White (Non-colored). Non-sterile,Polymer Coated | Encore Sterile Powder-Free Polymer CoatedLatex Surgical Glovewith Hydrasoft Coating(containing glycerine)and Protein LabelingClaim (50mg or less) | MICRO-TOUCH®DENTA-GLOVE® NitrileHydraSoft™ Non-Sterile Powder-FreeExamination Glove | Not applicable | |
| 510k Number | K123469 | K051793 | Pending | Not Applicable |
| Product Owner | Wear Safe Malaysia | Ansell Healthcare | Ansell Healthcare | Ansell Healthcare |
| Product Code | LZA | KGO | LZA | Same |
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 878.4460 | 21 CFR 880.6250 | Same |
| Regulatory Class | 1 | 1 | 1 | Same |
| Regulation Name | Patient ExaminationGlove | Surgeon's Glove | Patient ExaminationGlove | Same |
| Iselin, NJ 088- | ||||
| Intended Uses | The patientexamination glove is adisposable deviceintended for medicalpurposes that is wornon the examiner's handto preventcontamination betweenpatient and examiner | The surgical glove isintended to be worn byoperating roompersonnel to protect asurgical wound fromcontamination. Thelatex glove contain 50micrograms or less ofwater extractable pergram | The patientexamination glove is adisposable deviceintended for medicalpurposes that is wornon the examiner'shand to preventcontaminationbetween patient andexaminer | Same |
| MaterialComposition | Synthetic nitrile rubber | Natural rubber latex | Synthetic nitrile rubber | Same |
| Coating | Polyacrylic polymerinner coating to aiddonning | Polyurethane polymerinner coating to aiddonning | Polyacrylic polymerinner coating to aiddonning | Same |
| HydraSoftCoating | N/A | HydraSoft™ Coatingcoated on the donningsurface | HydraSoft™ Coatingcoated on the donningsurface | Different frompredicate |
| Design | Non-sterile | Sterile | Non-sterile | Same |
| Single use | Single use | Single use | Same | |
| Powder-free | Powder-free | Powder-free | Same | |
| Ambidextrous | Hand specific | Ambidextrous | Same | |
| Beaded cuff | Beaded cuff | Beaded cuff | Same | |
| Color | White | White | White | Same |
| Shelf Life | 3 years | 3 years | 3 years | Same |
| Performance | Same | |||
| a. Dimensions | Meets ASTM D6319-10requirements | Meets ASTM 3577requirements | Meets ASTM D6319-10requirements | |
| b. PhysicalProperties | Meets ASTM D6319-10requirements | Meets ASTM 3577requirements | Meets ASTM D6319-10requirements | Same |
| c. Freedom fromholes | Meets ASTM D6319-10requirements of GI, AQL2.5 | Meets ASTM 3577requirementsof GI, AQL 1.5 | Meets ASTM D6319-10requirements of GI,AQL 2.5 | Same |
| d. PowderResidual | Meets ASTM D6319-10requirements; Notmore than 2.0mg/glove | Meets ASTM 3577requirements; Not morethan 2.0mg/glove | Meets ASTM D6319-10requirements; Notmore than2.0mg/glove | Same |
| e. Sterility | Non-sterile | Sterile | Non-sterile | Same |
| Biocompatibility | Passes Primary SkinIrritation Test andDermal SensitizationTest | Passes Primary SkinIrritation Test andDermal SensitizationTest | "Under the conditionsof the study, not anirritant" and "Underthe conditions of thestudy, not a sensitizer" | Same |
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Pre-market Notification: Traditional 510(k) Submission Micro-Touch Denta-Glove with HydraSoft Coating Nitrile Examination Glove
The MICRO-TOUCH® DENTA-GLOVE® Nitrile HydraSoft™ are non-sterile, single use only, disposable, powder free patient examination gloves. The glove is made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the glove to make donning easy. Hydrasoft coating glycerine) is applied on top of the polymer coating on the glove inner surface.
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The subject device meets the applicable requirements for patient examination gloves regarding dimensions and sizes, physical properties, freedom from holes, and powder residues as found in the following standards: ASTM D6319, ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization and irritation, in accord with the ISO 10993 series of standards.
Performance Data:
A clinical study was not conducted on the subject or predicate devices.
Substantial Equivalence Statement
The Micro-Touch Denta-Glove with HydraSoft Coating Nitrile Patient Examination Glove is as safe and effective as the predicate device with respect to design, technological characteristics, intended use and conformance to standard requirements.
Conclusion
The conclusions drawn from the non clinical tests demonstrate that theMicro-Touch Denta-Glove with HydraSoft Coating Nitrile Patient Examination Glove is as safe and effective as the legally marketed predicate device previously cleared under K123469, Class I (21 CFR 880.6250, Product Code: LZA).
§ 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.