Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim

K191869 · Molnlycke Health Care Us, LLC · KGO · Mar 13, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K191869
• Device Name: Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
• Applicant: Molnlycke Health Care Us, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Mar 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended 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. 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

Device Story

Disposable, sterile, powder-free synthetic polyisoprene surgical gloves; straw-colored overglove and blue underglove; used independently or as double-gloving pair. Provides barrier against infectious materials/contaminants in surgical settings. Features 'Low Dermatitis Potential' claim, indicating reduced potential for sensitizing users to chemical additives. Used by healthcare professionals in surgical environments. Benefits include protection for patient and clinician while minimizing risk of contact dermatitis.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-10, ISO 10993-11), physical properties (ASTM D3577-09), and sensitization testing (Modified Draize-95).

Technological Characteristics

Synthetic polyisoprene material; sterile; powder-free; hand-specific; beaded cuff; straw (overglove) or blue (underglove) color. Sterilization via radiation (10^-6 SAL). Dimensions and physical properties meet ASTM D3577-09(2015). Freedom from holes meets ASTM D5151-06(2015) and 21 CFR 800.20.

Indications for Use

Indicated for use as a disposable, sterile, powder-free polyisoprene surgical glove (or underglove) to provide a barrier against infectious materials and contaminants in surgical settings.

Regulatory Classification

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.

Predicate Devices

• Biogel® PI UltraTouch S Surgical Glove and Biogel® PI UltraTouch S Indicator Underglove (K190077)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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, LLC<br>5550 Peachtree Parkway, Suite 500<br>Norcross, GA 30092<br>Registration number: 3004763499<br>Owner/Operator Number: 8030877 |
| Submission Correspondent: | Leonard Stewart<br>Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone]<br>email: [e-mail] |
| Trade/Proprietary Names: | Biogel® PI UltraTouch S Surgical Glove with a Low Dermatitis<br>Potential Claim and Biogel® PI UltraTouch S Indicator Underglove<br>with 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 UltraTouch<br>S 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:<br>Summary of technological characteristics of the subject device<br>compared to the predicate device<br>(overglove) | | | | (underglove) | | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--|--|
| | Biogel® PI<br>UltraTouch S<br>Surgical<br>Glove with<br>Low<br>Dermatitis<br>Potential<br>Claim<br>(Subject<br>Device) | Biogel® PI<br>UltraTouch<br>S Surgical<br>Glove<br>(Predicate<br>Device) | Comment | Biogel® PI<br>UltraTouch S<br>Indicator<br>Underglove<br>with Low<br>Dermatitis<br>Potential<br>Claim<br>(Subject<br>Device) | Biogel® PI<br>UltraTouch<br>S Indicator<br>Underglove<br>(Predicate<br>Device) | Comment | | |
| 510(k)<br>Number | K191869 | K190077 | - | K191869 | K190077 | - | | |
| Manufacturer | Mölnlycke | Mölnlycke | Identical | Mölnlycke | Mölnlycke | Identical | | |
| Regulation<br>number | 21CFR<br>878.4460 | 21CFR<br>878.4460 | Identical | 21CFR<br>878.4460 | 21CFR<br>878.4460 | Identical | | |
| Regulation<br>name | Surgeon's<br>Glove | Surgeon's<br>Glove | Identical | Surgeon's<br>Glove | Surgeon's<br>Glove | Identical | | |
| Regulatory<br>class | Class 1 | Class 1 | Identical | Class 1 | Class 1 | Identical | | |
| Product code | KGO | KGO | Identical | KGO | KGO | Identical | | |
| Intended use | Powder-Free<br>Surgeon's<br>Glove | Powder-Free<br>Surgeon's<br>Glove | Identical | Powder-Free<br>Surgeon's<br>Glove | Powder-Free<br>Surgeon's<br>Glove | Identical | | |
| Indication for<br>use | Biogel® PI<br>UltraTouch S<br>Surgical Glove<br>with a low<br>dermatitis<br>potential claim<br>is a<br>disposable<br>device made<br>of<br>polyisoprene,<br>that is<br>intended to be<br>worn on the<br>hands, usually<br>in surgical<br>settings, to<br>provide a<br>barrier against | Biogel® PI<br>UltraTouch S<br>Surgical<br>Glove is a<br>disposable<br>device made<br>of<br>polyisoprene,<br>that is<br>intended to<br>be worn on<br>the hands,<br>usually in<br>surgical<br>settings, to<br>provide a<br>barrier<br>against | Same | Biogel® PI<br>UltraTouch S<br>Indicator<br>Underglove<br>with a low<br>dermatitis<br>potential claim<br>is a disposable<br>device made of<br>polyisoprene,<br>blue in color<br>that is intended<br>to be worn on<br>the hands,<br>usually in<br>surgical<br>settings, to<br>provide a<br>barrier against | Biogel® PI<br>UltraTouch S<br>Indicator<br>Underglove<br>is a<br>disposable<br>device made<br>of<br>polyisoprene,<br>blue in color<br>that is<br>intended to<br>be worn on<br>the hands,<br>usually in<br>surgical<br>settings, to<br>provide a<br>barrier | Same | | |

## Technological Characteristics:

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| | Summary of technological characteristics of the subject device compared to the predicate device | | | | | |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------|
| | potentially<br>infectious<br>material and<br>other<br>contaminants | potentially<br>infectious<br>material and<br>other<br>contaminants | | potentially<br>infectious<br>material and<br>other<br>contaminants | potentially<br>infectious<br>material and<br>other<br>contaminants | |
| Low<br>Dermatitis<br>Potential<br>Claim | Low<br>dermatitis<br>potential:<br>reduced<br>potential for<br>sensitizing<br>users to<br>chemical<br>additives | | | Low<br>dermatitis<br>potential:<br>reduced<br>potential for<br>sensitizing<br>users to<br>chemical<br>additives | | |
| Material | Synthetic<br>Polyisoprene | Synthetic<br>Polyisoprene | Identical | Synthetic<br>Polyisoprene | Synthetic<br>Polyisoprene | 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<br>(Natural) | Straw<br>(Natural) | Identical | Blue | Blue | Identical |
| Sterilization<br>method | Radiation | Radiation | Identical | Radiation | Radiation | Identical |
| Sterility<br>Assurance<br>Level (SAL) | 10-6 SAL | 10-6 SAL | Identical | 10-6 SAL | 10-6 SAL | Identical |
| Dimensions<br>& physical<br>properties | Meets ASTM<br>D3577-<br>09(2015) | Meets ASTM<br>D3577-<br>09(2015) | Identical | Meets ASTM<br>D3577-<br>09(2015) | Meets ASTM<br>D3577-<br>09(2015) | Identical |
| Freedom<br>from holes | AQL meets 21<br>CFR 800.20<br>and ASTM<br>D3577-<br>09(2015)<br>requirements | AQL meets<br>21 CFR<br>800.20 and<br>ASTM<br>D3577-<br>09(2015)<br>requirements | Identical | AQL meets 21<br>CFR 800.20<br>and ASTM<br>D3577-<br>09(2015)<br>requirements | AQL meets<br>21 CFR<br>800.20 and<br>ASTM<br>D3577-<br>09(2015)<br>requirements | Identical |
| Powder<br>residual | Meets<br>requirements<br>of ≤ 2.0<br>mg/glove for<br>Powder-free<br>designation<br>per ASTM<br>D3577-<br>09(2015) | Meets<br>requirements<br>of ≤ 2.0<br>mg/glove for<br>Powder-free<br>designation<br>per ASTM<br>D3577-<br>09(2015) | Identical | Meets<br>requirements of<br>≤ 2.0 mg/glove<br>for Powder-free<br>designation per<br>ASTM D3577-<br>09(2015) | Meets<br>requirements<br>of ≤ 2.0<br>mg/glove for<br>Powder-free<br>designation<br>per ASTM<br>D3577-<br>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 Gloves<br>ASTM 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 Gloves<br>ASTM 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 S<br>Surgical Glove with Low<br>Dermatitis Potential Claim<br>(Subject Device), Biogel® PI<br>UltraTouch S Indicator<br>Underglove with Low<br>Dermatitis Potential<br>Claim (Subject Device) | Biogel® PI UltraTouch S<br>Surgical Glove (Predicate<br>Device), Biogel® PI<br>UltraTouch S Indicator<br>Underglove (Predicate<br>Device) | Comment |
| Clinical testing | Clinical data was not required | Clinical data was not<br>required | 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).