Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro

K193573 · Molnlycke Health Care Us, LLC · KGO · Apr 10, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K193573
• Device Name: Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
• Applicant: Molnlycke Health Care Us, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Apr 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Skinsense polyisoprene underglove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

Device Story

Sterile, single-use, powder-free surgical gloves constructed of synthetic polyisoprene or polychloroprene. Used in surgical settings by healthcare professionals to provide a barrier against infectious materials and contaminants. Subject devices are existing cleared gloves with an added claim for resistance to chemotherapy drug permeation. Testing performed per ASTM D6978-05 (2019) to determine breakthrough detection times for various chemotherapy agents. Output is a physical barrier; healthcare providers use the gloves to protect themselves from exposure to hazardous drugs and infectious agents during surgical procedures.

Clinical Evidence

No clinical data. Bench testing only. Permeation testing performed per ASTM D6978-05 (2019) to assess resistance to chemotherapy drugs. Breakthrough detection times reported for 24 chemotherapy agents.

Technological Characteristics

Materials: Synthetic polyisoprene or polychloroprene. Design: Single-use, sterile, powder-free, hand-specific, beaded cuff. Sterilization: Irradiation (SAL 10^-6). Compliance: ASTM D6978-05 (2019) for chemotherapy resistance; ASTM D3577-09 (2015) for physical properties, freedom from holes, and powder residue; 21 CFR 800.20 for freedom from holes.

Indications for Use

Indicated for use as a disposable, sterile, powder-free surgeon's glove to provide a barrier against infectious materials and contaminants in surgical settings. Tested for resistance to permeation by chemotherapy drugs per ASTM D6978.

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® G Surgical Glove tested for use with chemotherapy agents (K140477)
• Biogel® Skinsense® Surgical Glove tested for use with chemotherapy agents (K140477)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

April 10, 2020

Molnlycke Health Care US LLC. Calen Souther Regulatory Affairs Specialist 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

Re: K193573

Trade/Device Name: Biogel® Skinsense® Indicator® Underglove tested for use with chemotherapy agents, Biogel® PI UltraTouch® tested for use with chemotherapy agents, Biogel® PI Indicator® Underglove tested for use with chemotherapy agents, Biogel® PI tested for use with chemotherapy agents, Biogel® PI Micro tested for use with chemotherapy agents

Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: January 16, 2020 Received: January 21, 2020

Dear Calen Souther:

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.

{1}------------------------------------------------

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,

CAPT 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K193573

Device Name

Biogel PI Indicator Underglove tested for use with chemotherapy agents

Indications for Use (Describe)

The Skinsense polyisoprene underglove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

[continued on next page]

| 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

[K193573 Indications for Use, continued]

| Biogel® PI Indicator® Underglove<br>Tested for use with chemotherapy agents | |
|-----------------------------------------------------------------------------|-------------------------------------------------------------|
| Drug and Concentration | Breakthrough detection time in<br>minutes (0.01µg/cm²/mins) |
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 17.3 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan)<br>20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 |
| Doxorubicin Hydrochloride<br>2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 24.1 |
| Vincristine Sulfate 1 mg/ml | >240 |

- י Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 17.3 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 24.1 minutes

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known) K193573

Device Name

Biogel PI Micro tested for use with chemotherapy agents

Indications for Use (Describe)

The Biogel PI Micro Surgical Glove is a disposable device made of polyisoprene material that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

[continued on next page]

| 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

[K193573 Indications for Use, continued]

| Biogel® PI Micro<br>Tested for use with chemotherapy agents | |
|-------------------------------------------------------------|-------------------------------------------------------------|
| Drug and Concentration | Breakthrough detection time in<br>minutes (0.01µg/cm²/mins) |
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 10.0 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan)<br>20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 |
| Doxorubicin Hydrochloride<br>2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 20.3 |
| Vincristine Sulfate 1 mg/ml | >240 |

- י Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 10.0 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 20.3 minutes

{6}------------------------------------------------

# Indications for Use

510(k) Number (if known) K193573

Device Name

Biogel PI UltraTouch tested for use with chemotherapy agents

Indications for Use (Describe)

A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

[continued on next page]

| 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{7}------------------------------------------------

[K193573 Indications for Use, continued]

| Biogel® PI UltraTouch | |
|-----------------------------------------|----------------------------------------------------------|
| Tested for use with chemotherapy agents | |
| Drug and Concentration | Breakthrough detection time in minutes (0.01µg/cm²/mins) |
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 24.2 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 17.9 |
| Vincristine Sulfate 1 mg/ml | >240 |

- י Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 24.2 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 17.9 minutes

{8}------------------------------------------------

# Indications for Use

510(k) Number (if known) K193573

Device Name

Biogel PI tested for use with chemotherapy agents

Indications for Use (Describe)

A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

[continued on next page]

| 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{9}------------------------------------------------

[K193573 Indications for Use, continued]

| Drug and Concentration | Breakthrough detection time in<br>minutes (0.01µg/cm²/mins) |
|----------------------------------------|-------------------------------------------------------------|
| | |
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 26.7 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan)<br>20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 |
| Doxorubicin Hydrochloride<br>2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 28.7 |
| Vincristine Sulfate 1 mg/ml | >240 |

- י Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 26.7 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 28.7 minutes

{10}------------------------------------------------

# Indications for Use

510(k) Number (if known) K193573

Device Name

Biogel Skinsense Indicator Underglove tested for use with chemotherapy agents

Indications for Use (Describe)

A powder-free, sterile, surgeon's glove is a disposable device made of non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

[continued on next page]

| 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{11}------------------------------------------------

[K193573 Indications for Use, continued]

| Drug and Concentration | Breakthrough detection time in |
|-------------------------------------|--------------------------------|
| | minutes (0.01µg/cm²/mins) |
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 6.6 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 16.9 |
| Vincristine Sulfate 1 mg/ml | >240 |

- י Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 6.6 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 16.9 minutes

{12}------------------------------------------------

# 510(k) Summary

The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92(c).

| Date Prepared: | March 23, 2020 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Mölnlycke Health Care US, LLC.<br>5550 Peachtree Parkway, Suite 500<br>Norcross, GA 30092<br>Registration Number: 3004763499<br>Owner/Operator Number: 8030877 |
| Official Correspondent: | Calen Souther<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Trade/Proprietary Names: | Biogel® Skinsense® Indicator® Underglove tested for use with<br>chemotherapy agents<br>Biogel® PI UltraTouch® tested for use with chemotherapy<br>agents<br>Biogel® PI Indicator® Underglove tested for use with<br>chemotherapy agents<br>Biogel® PI tested for use with chemotherapy agents<br>Biogel® PI Micro tested for use with chemotherapy agents |
| Common Name: | Surgeon's Gloves |
| Regulation Name: | Non-powdered surgeon's gloves |
| Device Class: | Class I |
| Regulation Number: | 21 CFR 878.4460 |
| Product Code: | KGO, LZC |
| Predicate Device Information: | K140477 |
| | Biogel® PI UltraTouch® G Surgical Glove tested for use with<br>chemotherapy agents |
| | Biogel® Skinsense® Surgical Glove tested for use with<br>chemotherapy agents |

{13}------------------------------------------------

### Reason for 510(k) submission

The purpose of this Traditional 510(k) submission is to add a "Tested for use with chemotherapy agents" claim to the following existing, 510(k) cleared surgical gloves: Biogel® Skinsense® Underglove, Biogel® Pl UltraTouch®, Biogel® PI Indicator® Underglove, Biogel® PI, Biogel® PI Micro.

## Description of Devices

The Biogel® surgical gloves that are the subject of this submission are sterile, single-use, powder-free gloves that are constructed of either synthetic polyisoprene or synthetic polychloroprene. Refer to Tables 6-1 to 6-5 for a detailed description of the technological characteristics and comparison to the applicable predicate device.

### Indications for Use

## Biogel® Skinsense® Indicator® Underglove tested for use with chemotherapy agents

A powder-free, sterile, surgeon's glove is a disposable device made of non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

| Drug and Concentration | Breakthrough<br>detection time in<br>minutes<br>(0.01µg/cm²/mins) |
|-------------------------------------------|-------------------------------------------------------------------|
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 6.6 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide<br>(Cytoxan)<br>20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10<br>mg/ml | >240 |
| Doxorubicin<br>Hydrochloride<br>2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20<br>mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1<br>mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |

{14}------------------------------------------------

| Mitomycin C 0.5 mg/ml | >240 |
|-----------------------------|------|
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 16.9 |
| Vincristine Sulfate 1 mg/ml | >240 |

- Carmustine (3.3 mg/ml) has a minimum breakthrough time of 6.6 minutes.
- . Thiotepa (10 mg/ml) has a minimum breakthrough time of 16.9 minutes

## Biogel® PI Micro tested for use with chemotherapy agents

The Biogel Pl Micro Surgical Glove is a disposable device made of polyisoprene material that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

| Drug and Concentration | Breakthrough<br>detection time in<br>minutes<br>(0.01µg/cm²/mins) |
|-------------------------------------------|-------------------------------------------------------------------|
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 10.0 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide<br>(Cytoxan)<br>20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10<br>mg/ml | >240 |
| Doxorubicin<br>Hydrochloride<br>2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20<br>mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1<br>mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |

{15}------------------------------------------------

| Mitomycin C 0.5 mg/ml | >240 |
|-----------------------------|------|
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 20.3 |
| Vincristine Sulfate 1 mg/ml | >240 |

- Carmustine (3.3 mg/ml) has a minimum breakthrough time of 10.0 minutes.
- . Thiotepa (10 mg/ml) has a minimum breakthrough time of 20.3 minutes

## Biogel® PI UltraTouch® tested for use with chemotherapy agents

A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

| Drug and Concentration | Breakthrough detection time in minutes (0.01µg/cm²/mins) |
|-------------------------------------|----------------------------------------------------------|
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 24.2 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |

{16}------------------------------------------------

| Mitomycin C 0.5 mg/ml | >240 |
|-----------------------------|------|
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 17.9 |
| Vincristine Sulfate 1 mg/ml | >240 |

- Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 24.2 minutes.
- . Thiotepa (10 mg/ml) has a minimum breakthrough time of 17.9 minutes

## Biogel® PI tested for use with chemotherapy agents

A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

| Drug and Concentration | Breakthrough<br>detection time in<br>minutes<br>(0.01µg/cm²/mins) |
|-------------------------------------------|-------------------------------------------------------------------|
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 26.7 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide<br>(Cytoxan)<br>20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10<br>mg/ml | >240 |
| Doxorubicin<br>Hydrochloride<br>2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20<br>mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1<br>mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |

{17}------------------------------------------------

| Mitomycin C 0.5 mg/ml | >240 |
|--------------------------------|------|
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6<br>mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 28.7 |
| Vincristine Sulfate 1<br>mg/ml | >240 |

- Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 26.7 minutes.
- . Thiotepa (10 mg/ml) has a minimum breakthrough time of 28.7 minutes

## Biogel® PI Indicator® Underglove tested for use with chemotherapy agents

The Skinsense polyisoprene underglove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

| Drug and Concentration | Breakthrough<br>detection time in<br>minutes<br>(0.01µg/cm²/mins) |
|-------------------------------------------|-------------------------------------------------------------------|
| Bleomycin 15 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carmustine 3.3 mg/ml | 17.3 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide<br>(Cytoxan)<br>20 mg/ml | >240 |
| Cytarabine 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10<br>mg/ml | >240 |
| Doxorubicin<br>Hydrochloride<br>2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Etoposide (Toposar) 20<br>mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 |
| Mechlorethamine HCl 1<br>mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 |

{18}------------------------------------------------

| Mitomycin C 0.5 mg/ml | >240 |
|-----------------------------|------|
| Mitoxantrone 2 mg/ml | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 |
| Paraplatin 10 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Thiotepa 10 mg/ml | 24.1 |
| Vincristine Sulfate 1 mg/ml | >240 |

- . Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 17.3 minutes.
- Thiotepa (10 mg/ml) has a minimum breakthrough time of 24.1 minutes ■

{19}------------------------------------------------

| Table 6-1: Technological Characteristics Comparison |
|-----------------------------------------------------|
|-----------------------------------------------------|

| | Subject Device | Predicate Device | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Feature | Biogel® Skinsense® Indicator® Underglove tested for use with chemotherapy agents | Biogel® Skinsense® Surgical Glove tested for use with chemotherapy agents | |
| 510(k) clearance | Originally cleared under K053102; subject of this premarket notification to add "tested for use with chemotherapy agents" claim | K140477 | |
| Manufacturer | Mölnlycke Health Care | Mölnlycke Health Care | |
| Regulation | 21 CFR 878.4460, | 21 CFR 878.4460, | |
| Class Name | Surgeon's Gloves | Surgeon's Gloves | |
| Classification | Class I | Class I | |
| Product Code | KGO, LZC | KGO, LZC | |
| Indication for Use | A powder-free, sterile, surgeon's glove is a disposable device made of non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.<br><br>In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: | Biogel® Skinsense® Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material and other contaminants.<br><br>In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | |
| | Drug and Concentration<br>Breakthrough detection time in minutes (0.01µg/cm²/mins)<br>Bleomycin 15 mg/ml >240<br>Busulfan 6 mg/ml >240<br>Carmustine 3.3 mg/ml 6.6<br>Cisplatin 1.0 mg/ml >240<br>Cyclophosphamide (Cytoxan) 20 mg/ml >240<br>Cytarabine 100 mg/ml >240 | Drug and Concentration<br>Breakthrough detection time in minutes (0.01µg/cm²/mins)<br>Bleomycin 15 mg/ml >240<br>Busulfan 6 mg/ml >240<br>Carmustine 3.3 mg/ml 60.2<br>Cisplatin 1.0 mg/ml >240<br>Cyclophosphamide (Cytoxan) 20 mgl/ml >240<br>Cytarabine 100 mg/ml >240<br>Dacarbazine (DTIC) 10 mg/ml >240 | |
| Dacarbazine (DTIC) 10 mg/ml | >240 | Doxorubicin Hydrochloride 2 mg/ml | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 | Ellence 2 mg/ml | >240 |
| Ellence 2 mg/ml | >240 | Etoposide (Toposar) 20 mg/ml | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | Fludarabine 25 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 | Fluorouracil 50 mg/ml | >240 |
| Fluorouracil 50 mg/ml | >240 | Idarubicin 1 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 | Ifosfamide 50 mg/ml | >240 |
| Ifosfamide 50 mg/ml | >240 | Mechlorethamine HCl 1 mg/ml | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | Melphalan 5 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 | Methotrexate 25 mg/ml | >240 |
| Methotrexate 25 mg/ml | >240 | Mitomycin C 0.5 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 | Mitoxantrone 2 mg/ml | >240 |
| Mitoxantrone 2 mg/ml | >240 | Paclitaxel (Taxol) 6 mg/ml…