The Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, 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. 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.

The Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber lates, 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. 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.

The Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, 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. 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® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber latex, 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. 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.

The Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents 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. 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.

The Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents 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. 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.

The Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents 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. 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 Description

AI/ML Overview

The document provides information on the performance of several types of surgical gloves when tested for resistance to permeation by chemotherapy drugs. The acceptance criteria and the study method are based on ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The implicit acceptance criterion for these gloves, based on the Breakthrough detection time values and the common understanding in such tests, is that the gloves should demonstrate resistance to permeation by chemotherapy drugs for a reasonable duration (e.g., as long as possible, or at least a certain minimum time). While a specific "pass/fail" threshold is not explicitly stated as an acceptance criterion in minutes, the values of ">240 minutes" indicate excellent performance for most drugs. The lower values for Carmustine and Thiotepa highlight instances where permeation occurs more quickly.

The reported device performance for each glove type and chemotherapy drug is provided in the tables across the document. Below is a summary table combining this information as an example, for "Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents" (from page 3):

Drug and Concentration	Acceptance Criteria (Breakthrough Detection Time - implicit goal)	Reported Device Performance (Breakthrough detection time in minutes (0.01µg/cm²/mins))
Bleomycin 15 mg/ml	As long as possible, ideally >240 minutes	>240
Busulfan 6 mg/ml	As long as possible, ideally >240 minutes	>240
Carmustine 3.3 mg/ml	As long as possible, ideally >240 minutes	12.1
Cisplatin 1 mg/ml	As long as possible, ideally >240 minutes	>240
Cyclophosphamide (Cytoxan) 20 mg/ml	As long as possible, ideally >240 minutes	>240
Cytarabine HCL 100 mg/ml	As long as possible, ideally >240 minutes	>240
Dacarbazine (DTIC) 10 mg/ml	As long as possible, ideally >240 minutes	>240
Doxorubicin HCL 2 mg/ml	As long as possible, ideally >240 minutes	>240
Ellence 2 mg/ml	As long as possible, ideally >240 minutes	>240
Etoposide (Toposar) 20 mg/ml	As long as possible, ideally >240 minutes	>240
Fludarabine 25 mg/ml	As long as possible, ideally >240 minutes	>240
Fluorouracil 50 mg/ml	As long as possible, ideally >240 minutes	>240
Idarubicin 1 mg/ml	As long as possible, ideally >240 minutes	>240
Ifosfamide 50 mg/ml	As long as possible, ideally >240 minutes	>240
Mechlorethamine HCl 1 mg/ml	As long as possible, ideally >240 minutes	>240
Melphalan 5 mg/ml	As long as possible, ideally >240 minutes	>240
Methotrexate 25 mg/ml	As long as possible, ideally >240 minutes	>240
Mitomycin C 0.5 mg/ml	As long as possible, ideally >240 minutes	>240
Mitoxantrone 2 mg/ml	As long as possible, ideally >240 minutes	>240
Paclitaxel (Taxol) 6 mg/ml	As long as possible, ideally >240 minutes	>240
Paraplatin 10 mg/ml	As long as possible, ideally >240 minutes	>240
Rituximab 10 mg/ml	As long as possible, ideally >240 minutes	>240
Thiotepa 10 mg/ml	As long as possible, ideally >240 minutes	14.1
Vincristine Sulfate 1 mg/ml	As long as possible, ideally >240 minutes	>240

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size for the test set (number of gloves tested per drug type). It only reports the breakthrough detection time.
The data provenance is from testing conducted in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a standardized, laboratory-based prospective testing methodology. The country of origin of the data is not specified, but the submission is to the U.S. FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This type of study (chemical permeation testing of medical devices) does not typically involve human expert adjudication in the same way, for example, a diagnostic image interpretation study would. The "ground truth" is established by the objective, quantitative measurement of chemical permeation according to the specified ASTM standard. Therefore, there are no "experts" in the sense of clinical reviewers establishing a ground truth.

4. Adjudication Method for the Test Set:

Not applicable. As described above, this is a laboratory test with objective measurements, not a human interpretation task requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a standalone performance test of a physical device against chemical permeation, not an AI-assisted diagnostic task involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This entire study is a standalone performance assessment of a physical device. There is no "algorithm" or "human-in-the-loop" concept involved. The performance is the intrinsic resistance of the glove material to chemical permeation.

7. The Type of Ground Truth Used:

The ground truth used is based on objective, quantitative measurements of chemical permeation using analytical methods specified or implied by the ASTM D6978 standard. The "Breakthrough detection time" is the measured outcome, indicating the time at which a quantifiable amount of the chemotherapy drug permeates through the glove material.

8. The Sample Size for the Training Set:

Not applicable. This is a direct performance test of a manufactured product, not a machine learning model. There is no "training set" in this context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this type of device performance study.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 22, 2020

Molnlycke Health Care, US LLC Leonard Stewart Regulatory Affairs Specialist 5445 Triangle Parkway, Suite 400 Peachtree Corners, Georgia 30092

Re: K202090

Trade/Device Name:

Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents; Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents; Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents; Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents; Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents; Biogel® PI Ultra Touch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents: Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis 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: July 24, 2020 Received: July 28, 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.

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

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.

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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. For: Elizabeth F. Claverie, MS 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

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Indications for Use

510(k) Number (if known) K202090

Device Name

Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents

Indications for Use (Describe)

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 PRAStaff(@fda.hhs.gov

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

Drug and Concentration	Breakthroughdetection time inminutes(0.01µg/cm²/mins)
Bleomycin 15 mg/ml	>240
Busulfan 6 mg/ml	>240
Carmustine 3.3 mg/ml	12.1
Cisplatin 1 mg/ml	>240
Cyclophosphamide (Cytoxan)20 mg/ml	>240
Cytarabine HCL 100 mg/ml	>240
Dacarbazine (DTIC) 10 mg/ml	>240
Doxorubicin HCL 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	14.1
Vincristine Sulfate 1 mg/ml	>240

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

Indications for Use

510(k) Number (if known) K202090

Device Name

Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotheray agents

Indications for Use (Describe)

[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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

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	11.7
Cisplatin 1 mg/ml	>240
Cyclophosphamide (Cytoxan) 20 mg/ml	>240
Cytarabine HCL 100 mg/ml	>240
Dacarbazine (DTIC) 10 mg/ml	>240
Doxorubicin HCL 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	15.6
Vincristine Sulfate 1 mg/ml	>240

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

Indications for Use

510(k) Number (if known) K202090

Device Name

Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents

Indications for Use (Describe)

[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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

Drug and Concentration	Breakthroughdetection time inminutes(0.01µg/cm²/mins)
Bleomycin 15 mg/ml	>240
Busulfan 6 mg/ml	>240
Carmustine 3.3 mg/ml	14.0
Cisplatin 1 mg/ml	>240
Cyclophosphamide (Cytoxan) 20 mg/ml	>240
Cytarabine HCL 100 mg/ml	>240
Dacarbazine (DTIC) 10 mg/ml	>240
Doxorubicin HCL 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	23.5
Vincristine Sulfate 1 mg/ml	>240

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

Indications for Use

510(k) Number (if known) K202090

Device Name

Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents

Indications for Use (Describe)

[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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

Drug and Concentration	Breakthroughdetection time inminutes(0.01µg/cm²/mins)
Bleomycin 15 mg/ml	>240
Busulfan 6 mg/ml	>240
Carmustine 3.3 mg/ml	5.3
Cisplatin 1 mg/ml	>240
Cyclophosphamide (Cytoxan)20 mg/ml	>240
Cytarabine HCL 100 mg/ml	>240
Dacarbazine (DTIC) 10 mg/ml	>240
Doxorubicin HCL 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	13.1
Vincristine Sulfate 1 mg/ml	>240

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

Indications for Use

510(k) Number (if known) K202090

Device Name

Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents

Indications for Use (Describe)

[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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

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	13.2
Cisplatin 1 mg/ml	>240
Cyclophosphamide (Cytoxan) 20 mg/ml	>240
Cytarabine HCL 100 mg/ml	>240
Dacarbazine (DTIC) 10 mg/ml	>240
Doxorubicin HCL 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	22.3
Vincristine Sulfate 1 mg/ml	>240

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

Indications for Use

510(k) Number (if known) K202090

Device Name

Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents

Indications for Use (Describe)

[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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

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	14.3
Cisplatin 1 mg/ml	>240
Cyclophosphamide (Cytoxan) 20 mg/ml	>240
Cytarabine HCL 100 mg/ml	>240
Dacarbazine (DTIC) 10 mg/ml	>240
Doxorubicin HCL 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	26.8
Vincristine Sulfate 1 mg/ml	>240

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

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K202090

Device Name

Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents

Indications for Use (Describe)

[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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

Drug and Concentration	Breakthroughdetection time inminutes(0.01µg/cm²/mins)
Bleomycin 15 mg/ml	>240
Busulfan 6 mg/ml	>240
Carmustine 3.3 mg/ml	15.2
Cisplatin 1 mg/ml	>240
Cyclophosphamide (Cytoxan)20 mg/ml	>240
Cytarabine HCL 100 mg/ml	>240
Dacarbazine (DTIC) 10 mg/ml	>240
Doxorubicin HCL 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	17.8
Vincristine Sulfate 1 mg/ml	>240

Regulation Number and Section

§ 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).