(245 days)
The Biogel® PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim is a disposable device made of polyisoprene, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The Biogel® PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene, and a single-use, sterile, blue underglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene. The overglove, and underglove may be used independently or worn as a double-gloving pair if desired.
This document is a 510(k) summary for a medical device (surgical gloves) and not a study describing the validation of an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/ML device is not applicable and cannot be extracted from the provided text.
The document discusses the substantial equivalence of the subject devices (Biogel® PI UltraTouch S Surgical Glove and Indicator Underglove with a Low Dermatitis Potential Claim) to predicate devices already on the market. The low dermatitis potential claim is supported by non-clinical testing.
Here's what can be extracted, although it pertains to non-AI/ML device testing:
1. Acceptance Criteria and Reported Device Performance (for the non-AI/ML medical device):
The acceptance criteria for the surgical gloves are primarily defined by adherence to recognized standards and the demonstration of "Low Dermatitis Potential."
| Test/Characteristic | Acceptance Criteria (Standard/Requirement) | Reported Device Performance (Subject Device) |
|---|---|---|
| Biocompatibility | ||
| Primary Skin Irritation | ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Not an irritant |
| ISO Closed Patch Sensitization | ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Not a sensitizer |
| Acute Systemic Toxicity | ISO 10993-11:2010 (Tests for systemic toxicity) | No mortality or evidence of systemic toxicity from the extracts |
| Performance Test | ||
| Low Dermatitis Potential | Modified Draize-95 Test (demonstrate reduced potential for sensitizing users to chemical additives) | Demonstrated Low dermatitis potential: reduced potential for sensitizing users to chemical additives |
| Physical Characteristics | ||
| Dimensions | ASTM D3577-09(2015) requirements for length, width, and thickness | Meets ASTM D3577-09(2015) requirements for length, width, and thickness. Identical to predicate. |
| Physical Properties | ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging | Meets ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging. Identical to Predicate. |
| Freedom from holes | 21 CFR 800.20 and ASTM D3577-09(2015) requirements of AQL 1.5; ASTM D5151-06(2015) (Detection of Holes in Medical Gloves) | Exceeds 21 CFR 800.20 and ASTM D3577-09(2015) requirements of AQL 1.5. Identical to predicate. |
| Powder residual | ≤ 2.0 mg/glove for Powder-free designation per ASTM D3577-09(2015); ASTM D6124-06(2017) (Residual Powder on Medical Gloves) | Meets powder level requirements for "Powder-free" designation per ASTM D3577-09(2015). Identical to predicate. |
2. Sample size used for the test set and the data provenance:
The document refers to "studies" for biocompatibility and performance, but does not specify sample sizes for these tests. The data provenance is implied to be from testing conducted by or for the manufacturer, Mölnlycke Health Care US, LLC. The testing is described as "non-clinical," meaning it does not involve human subjects in a clinical setting when assessing device performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device requiring expert ground truth establishment for algorithm performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device requiring adjudication of expert interpretations.
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 as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device. "Clinical data was not required" for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the surgical gloves is established by their adherence to defined physical, chemical, and biological performance characteristics measured against industry standards (e.g., ASTM, ISO) and specific test methodologies (e.g., Modified Draize-95 Test).
8. The sample size for the training set:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device that requires a training set and corresponding ground truth.
In summary, the provided FDA 510(k) summary is for a traditional Class I medical device (surgical gloves) and therefore does not contain the information typically associated with the validation of an AI/ML-driven device.
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March 13, 2020
Molnlycke Health Care, US LLC Leonard Stewart Regulatory Affairs Specialist 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092
Re: K191869
Trade/Device Name: Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: February 17, 2020 Received: February 18, 2020
Dear Leonard Stewart:
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 medical devices and radiation-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.
Elizabeth Claverie, M.S. 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
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Indications for Use
510(k) Number (if known)
K191869
Device Name
Biogel® PI UltraTouch S Surgical Glove with a Low Dermatis Potential Claim and Biogel® PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
Indications for Use (Describe)
The Biogel® PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim is a disposable device made of polyisoprene, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The Biogel® PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants
| 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 (K191869)
for
Biogel® PI UltraTouch S Surgical Glove with Low Dermatitis Potential Claim and Biogel® PI UltraTouch S Indicator Underglove with Low Dermatitis Potential Claim
| Date Prepared: | March 11, 2020 |
|---|---|
| Submission Sponsor: | Mölnlycke Health Care US, LLC5550 Peachtree Parkway, Suite 500Norcross, GA 30092Registration number: 3004763499Owner/Operator Number: 8030877 |
| Submission Correspondent: | Leonard StewartRegulatory Affairs SpecialistTel: 470-375-0178Fax: 678-245-7746email: leonard.stewart@molnlycke.com |
| Trade/Proprietary Names: | Biogel® PI UltraTouch S Surgical Glove with a Low DermatitisPotential Claim and Biogel® PI UltraTouch S Indicator Underglovewith a Low Dermatitis Potential Claim |
| Regulation Name: | Non-powered surgeon's glove |
| Common Name: | Surgeon's Glove |
| Classification Name: | Surgeon's Glove |
| Device Class: | Class I |
| Regulation Number: | 21 CFR 878.4460 |
| Product Code: | KGO |
| 510(k) Submission Number: | |
| Predicate Device Name(s): | Biogel® PI UltraTouch S Surgical Glove and Biogel® PI UltraTouchS Indicator Underglove (K190077) |
Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene, and a single-use, sterile, blue underglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene. The overglove, and underglove may be used independently or worn as a double-gloving pair if desired.
Indications for Use:
The Biogel® PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim is a disposable device made of polyisoprene, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
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The Bioge® Pl UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and othercontaminants
| Technological Characteristics:Summary of technological characteristics of the subject devicecompared to the predicate device(overglove) | (underglove) | |||||||
|---|---|---|---|---|---|---|---|---|
| Biogel® PIUltraTouch SSurgicalGlove withLowDermatitisPotentialClaim(SubjectDevice) | Biogel® PIUltraTouchS SurgicalGlove(PredicateDevice) | Comment | Biogel® PIUltraTouch SIndicatorUnderglovewith LowDermatitisPotentialClaim(SubjectDevice) | Biogel® PIUltraTouchS IndicatorUnderglove(PredicateDevice) | Comment | |||
| 510(k)Number | K191869 | K190077 | - | K191869 | K190077 | - | ||
| Manufacturer | Mölnlycke | Mölnlycke | Identical | Mölnlycke | Mölnlycke | Identical | ||
| Regulationnumber | 21CFR878.4460 | 21CFR878.4460 | Identical | 21CFR878.4460 | 21CFR878.4460 | Identical | ||
| Regulationname | Surgeon'sGlove | Surgeon'sGlove | Identical | Surgeon'sGlove | Surgeon'sGlove | Identical | ||
| Regulatoryclass | Class 1 | Class 1 | Identical | Class 1 | Class 1 | Identical | ||
| Product code | KGO | KGO | Identical | KGO | KGO | Identical | ||
| Intended use | Powder-FreeSurgeon'sGlove | Powder-FreeSurgeon'sGlove | Identical | Powder-FreeSurgeon'sGlove | Powder-FreeSurgeon'sGlove | Identical | ||
| Indication foruse | Biogel® PIUltraTouch SSurgical Glovewith a lowdermatitispotential claimis adisposabledevice madeofpolyisoprene,that isintended to beworn on thehands, usuallyin surgicalsettings, toprovide abarrier against | Biogel® PIUltraTouch SSurgicalGlove is adisposabledevice madeofpolyisoprene,that isintended tobe worn onthe hands,usually insurgicalsettings, toprovide abarrieragainst | Same | Biogel® PIUltraTouch SIndicatorUnderglovewith a lowdermatitispotential claimis a disposabledevice made ofpolyisoprene,blue in colorthat is intendedto be worn onthe hands,usually insurgicalsettings, toprovide abarrier against | Biogel® PIUltraTouch SIndicatorUndergloveis adisposabledevice madeofpolyisoprene,blue in colorthat isintended tobe worn onthe hands,usually insurgicalsettings, toprovide abarrier | Same |
Technological Characteristics:
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| Summary of technological characteristics of the subject device compared to the predicate device | ||||||
|---|---|---|---|---|---|---|
| potentiallyinfectiousmaterial andothercontaminants | potentiallyinfectiousmaterial andothercontaminants | potentiallyinfectiousmaterial andothercontaminants | potentiallyinfectiousmaterial andothercontaminants | |||
| LowDermatitisPotentialClaim | Lowdermatitispotential:reducedpotential forsensitizingusers tochemicaladditives | Lowdermatitispotential:reducedpotential forsensitizingusers tochemicaladditives | ||||
| Material | SyntheticPolyisoprene | SyntheticPolyisoprene | Identical | SyntheticPolyisoprene | SyntheticPolyisoprene | Identical |
| Design | Single use | Single use | Identical | Single use | Single use | Identical |
| Sterile | Sterile | Identical | Sterile | Sterile | Identical | |
| Powder-free | Powder-free | Identical | Powder-free | Powder-free | Identical | |
| Hand specific | Hand specific | Identical | Hand specific | Hand specific | Identical | |
| Beaded Cuff | Beaded cuff | Identical | Beaded cuff | Beaded cuff | Identical | |
| Coating | Yes | Yes | Identical | Yes | Yes | Identical |
| Color | Straw(Natural) | Straw(Natural) | Identical | Blue | Blue | Identical |
| Sterilizationmethod | Radiation | Radiation | Identical | Radiation | Radiation | Identical |
| SterilityAssuranceLevel (SAL) | 10-6 SAL | 10-6 SAL | Identical | 10-6 SAL | 10-6 SAL | Identical |
| Dimensions& physicalproperties | Meets ASTMD3577-09(2015) | Meets ASTMD3577-09(2015) | Identical | Meets ASTMD3577-09(2015) | Meets ASTMD3577-09(2015) | Identical |
| Freedomfrom holes | AQL meets 21CFR 800.20and ASTMD3577-09(2015)requirements | AQL meets21 CFR800.20 andASTMD3577-09(2015)requirements | Identical | AQL meets 21CFR 800.20and ASTMD3577-09(2015)requirements | AQL meets21 CFR800.20 andASTMD3577-09(2015)requirements | Identical |
| Powderresidual | Meetsrequirementsof ≤ 2.0mg/glove forPowder-freedesignationper ASTMD3577-09(2015) | Meetsrequirementsof ≤ 2.0mg/glove forPowder-freedesignationper ASTMD3577-09(2015) | Identical | Meetsrequirements of≤ 2.0 mg/glovefor Powder-freedesignation perASTM D3577-09(2015) | Meetsrequirementsof ≤ 2.0mg/glove forPowder-freedesignationper ASTMD3577-09(2015) | Identical |
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Summary of Non-Clinical/Clinical Testing:
| Summary of Non-Clinical Testing | |||
|---|---|---|---|
| Standard/Test/FDA Guidance | Biogel® PI UltraTouch S Surgical Glove with Low Dermatitis Potential Claim (Subject Device) | Biogel® PI UltraTouch S Indicator Underglove with Low Dermatitis Potential Claim (Subject Device) | |
| Biocompatibility: | |||
| Primary Skin Irritation | ISO 10993-10:2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, not an irritant. | Under the conditions of the study, not an irritant. |
| ISO Closed Patch Sensitization | ISO 10993-10:2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, not a sensitizer. | Under the conditions of the study, not a sensitizer. |
| Acute Systemic Toxicity Study | ISO 10993-11:2010 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | Under the conditions of the study, no mortality or evidence of systemic toxicity from the extracts. | Under the conditions of the study, no mortality or evidence of systemic toxicity from the extracts. |
| Performance Test: | |||
| Low Dermatitis Potential | Modified Draize-95 Test | Under the conditions of the study, the subject devices demonstrated Low dermatitis potential: reduced potential for sensitizing users to chemical additives | Under the conditions of the study, the subject devices demonstrated Low dermatitis potential: reduced potential for sensitizing users to chemical additives |
| Physical characteristics: | |||
| Dimensions | ASTM D3577-09(2015) Standard Specification for Rubber Surgical Gloves | Meets ASTM D3577-09(2015) requirements for length, width, and thickness. Identical to predicate. | Meets ASTM D3577-09(2015) requirements for length, width, and thickness. Identical to predicate. |
| Physical Properties | ASTM D3577-09(2015) Standard Specification for Rubber Surgical Gloves | Meets ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging. Identical to Predicate. | Meets ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging. Identical to Predicate. |
| Freedom from holes | ASTM D5151-06(2015) Standard Test Method for Detection of Holes in Medical GlovesASTM D3577-09(2015) Standard Specification for Rubber Surgical Gloves | Exceeds 21 CFR 800.20 and ASTM D3577-09(2015) requirements of AQL 1.5. Identical to predicate. | Exceeds 21 CFR 800.20 and ASTM D3577-09(2015) requirements of AQL 1.5. Identical to predicate. |
| Powder residual | ASTM D6124-06(2017) Standard Test Method for Residual Powder on Medical GlovesASTM D3577-09(2015) Standard Specification for Rubber Surgical Gloves | Meets powder level requirements for "Powder-free" designation per ASTM D3577-09(2015). Identical to predicate. | Meets powder level requirements for "Powder-free" designation per ASTM D3577-09(2015). Identical to predicate. |
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| Clinical Data Summary | |||
|---|---|---|---|
| Biogel® PI UltraTouch SSurgical Glove with LowDermatitis Potential Claim(Subject Device), Biogel® PIUltraTouch S IndicatorUnderglove with LowDermatitis PotentialClaim (Subject Device) | Biogel® PI UltraTouch SSurgical Glove (PredicateDevice), Biogel® PIUltraTouch S IndicatorUnderglove (PredicateDevice) | Comment | |
| Clinical testing | Clinical data was not required | Clinical data was notrequired | Identical |
Conclusion:
The conclusions drawn from the nonclinical test for Biogel® Pl UltraTouch S Surgical Glove with a low dermatitis potential claim and Biogel® Pl UltraTouch S Indicator Underglove with a low dermatitis potential claim demonstrates that these subject devices are as safe, as effective, and perform as well or better than the legally marketed predicate devices Biogel® Pl UltraTouch S Surgical Glove and Biogel® PI UltraTouch S Indicator Underglove (K190077).
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).