Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

K250313 · Harps Europe Manufacturing GmbH · KGO · Aug 19, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K250313
• Device Name: Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
• Applicant: Harps Europe Manufacturing GmbH
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Aug 19, 2025
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Sterile, single-use, powder-free synthetic polyisoprene rubber surgeon's gloves; green color. Worn by operating room personnel to provide a barrier against infectious materials and contaminants. Tested for permeation resistance against specific chemotherapy drugs and gastric acid per ASTM D6978-05. Device provides physical barrier protection; healthcare providers use gloves during surgical procedures to maintain sterile fields and protect patients from contamination. Benefits include reduced risk of surgical site infection and protection of personnel from exposure to hazardous chemotherapy agents.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D3577 (dimensions, physical properties), ASTM D5151 (freedom from holes), ASTM D6124 (powder-free), ISO 11137-1 (sterility), ASTM D6978-05 (chemotherapy permeation), and ISO 10993 series (biocompatibility: irritation, sensitization, systemic toxicity, pyrogenicity).

Technological Characteristics

Material: Synthetic polyisoprene rubber with synthetic polymeric inner coating. Design: Anatomical shape, curved fingers, beaded cuff. Sterilization: Radiation (SAL 10^-6). Connectivity: None. Standards: ASTM D3577-19, ASTM D6124-06, ASTM D5151-19, ASTM D412-16, ISO 11137-1/2, ASTM D6978-05.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. Not for use with Carmustine or Thiotepa due to low permeation times.

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

• Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves (K160781)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

August 19, 2025

HARPS Europe Manufacturing GmbH
% Jay Mansour
Regulatory consultant / Principal
Mansour Consulting LLC
845 Aronson Lake Court
Roswell, Georgia 30075

Re: K250313

Trade/Device Name: Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
Regulation Number: 21 CFR 878.4460
Regulation Name: Non-Powdered Surgeon's Glove
Regulatory Class: Class I, reserved
Product Code: KGO, LZC
Dated: February 3, 2025
Received: July 21, 2025

Dear Jay Mansour:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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assistance/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,

ALLAN GUAN -S

For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection
Control 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below

510(k) Number (if known)
K250313

Device Name
Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

Indications for Use (Describe)
The Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.

The tested drugs are:

| Compound | Minimum Breakthrough Time (minutes) |
| --- | --- |
| Carmustine (BCNU) (3.3 mg/ml) | 15.8 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Doxorubicin (2 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fluorouracil (50 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Thiotepa (THT) (10 mg/ml) | 24.6 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (10 mg/ml) | >240 |
| Daunorubicin HCl (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Gemcitabine HCl (38 mg/ml) | >240 |
| Idarubicin HCl (1 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCl (20 mg/ml) | >240 |
| Mechlorethamine HCl (1 mg/ml) | >240 |
| Melphalan HCl (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Vincristine Sulfate (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Chloroquine (50 mg/ml) | >240 |
| Cyclosporin A (100 mg/ml) | >240 |
| Epirubicin HCl (2 mg/ml) | >240 |
| Fludarabine Phosphate (25 mg/ml) | >240 |
| Oxaliplatin (2 mg/ml) | >240 |
| Retrovir (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Topotecan HCl (1 mg/ml) | >240 |
| Trisenox (Arsenic Trioxide) (1 mg/ml) | >240 |
| Velcade (Bortezomib) (1 mg/ml) | >240 |

Simulated Gastric Acid Fluid was also tested with a minimum breakthrough greater than 240 minutes.

FORM FDA 3881 (8/23)
PISC Publishing Services [phone]

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WARNING:

Please note the following drugs have extremely low permeation times:

Carmustine: 15.8 minutes and Thiotepa: 24.6 minutes. Do not use with Carmustine and Thiotepa.

Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ 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:

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FORM FDA 3881 (8/23)
Page 2 of 2
PSC Publishing Services [phone]

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HARPS Europe Manufacturing GmbH
K250313

# 510K Summary

510(k) Number: K250313

Submitter: HARPS Europe Manufacturing GmbH
TRIESTER BUNDESSTRASSE 26
WIMPASSING NIEDEROSTERREICH
Niederosterreich 2632
Austria

Contact Person(s): Dr. Alexander Weinert
Phone: [phone]
Email: [e-mail]

Correspondent: Mansour Consulting LLC
845 Aronson Lake Court
Roswell GA 30075
United States
Mr. Jay Mansour
Phone: [phone]
Email: [e-mail]

Date Prepared: 2025-08-14

## Name of Device

Trade Names: Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

Common Name: Non-powdered surgeon's glove

Classification Name: Surgeon's Gloves

Classification Regulation: 21 CFR 878.4460

Device Class: I

Product Code: KGO, LZC

Classification Panel: General and Plastic Surgery

## Legally Marketed Predicate Device

Primary Predicate: K160781
Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves

Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

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K250313

# Device Description

Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a sterile and disposable device. This glove is made of synthetic polyisoprene rubber inside coated with synthetic material to ease donning the glove. The device is intended to be worn on hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. These gloves were tested for use with Chemotherapy Drugs and Gastric Acid as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The device conforms to the following FDA recognized consensus standards: ASTM D3577-19, ASTM D6124-06, ASTM D5151-19, ASTM D412-16, ISO 11137-1:2006 + AMD1:2013 + AMD2:2018, ISO 11137-2:2013 + AMD1:2022, and ASTM D6978-05.

Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is available in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0.

# Indication for Use Statement

The Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination. The tested drugs are:

| Compound | Minimum Breakthrough Time (minutes) |
| --- | --- |
| Carmustine (BCNU) (3.3 mg/ml) | 15.8 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Doxorubicin (2 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fluorouracil (50 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Thiotepa (THT) (10 mg/ml) | 24.6 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (10 mg/ml) | >240 |
| Daunorubicin HCl (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Gemcitabine HCl (38 mg/ml) | >240 |
| Idarubicin HCl (1 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCl (20 mg/ml) | >240 |
| Mechlorethamine HCl (1 mg/ml) | >240 |
| Melphalan HCl (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |

Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

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K250313

Mitomycin C (0.5 mg/ml) >240
Mitoxantrone (2 mg/ml) >240
Vincristine Sulfate (1 mg/ml) >240
Busulfan (6 mg/ml) >240
Chloroquine (50 mg/ml) >240
Cyclosporin A (100 mg/ml) >240
Epirubicin HCl (2 mg/ml) >240
Fludarabine Phosphate (25 mg/ml) >240
Oxaliplatin (2 mg/ml) >240
Retrovir (10 mg/ml) >240
Rituximab (10 mg/ml) >240
Topotecan HCl (1 mg/ml) >240
Trisenox (Arsenic Trioxide) (1 mg/ml) >240
Velcade (Bortezomib) (1 mg/ml) >240

Simulated Gastric Acid Fluid was also tested with a minimum breakthrough greater than 240 minutes.

WARNING:
Please note the following drugs have extremely low permeation times:
Carmustine: 15.8 minutes and Thiotepa: 24.6 minutes. Do not use with Carmustine and Thiotepa.

Technological Characteristics

| | Predicate Device | Subject Device | Comparison |
| --- | --- | --- | --- |
| Trade name | Sempermed
Syntegra IR, Sterile
Powder Free
Synthetic Rubber
Surgeons Gloves | Sterile Powder Free
Synthetic Rubber
Surgeon's Gloves,
Green Color,
Tested For Use
With
Chemotherapy
Drugs and Gastric
Acid | Different |
| 510k Number | K160781 | K250313 | Different |
| Product Owner | Sempermed USA
Inc. | HARPS Europe
Manufacturing
GmbH | Different |
| Product Code | KGO | KGO, LZC | Same |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Regulatory Class | I | I | Same |
| Regulation Name | Non-powdered
Surgeon's Gloves | Non-powdered
Surgeon's glove | Same |
| Indications For Use | The Sterile Powder
Free Synthetic
Rubber Gloves is a
single use
disposable device
intended to be worn
by operating room | The Sterile Powder
Free Synthetic
Rubber Surgeon's
Gloves, Green
Color, Tested For
Use With
Chemotherapy | Different - Added
chemotherapy and
gastric acid testing |

Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

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| | personnel to protect
a surgical wound
from
contamination. | Drugs and Gastric
Acid is a single use
disposable device
intended to be worn
by operating room
personnel to protect
a surgical wound
from
contamination.
The tested drugs
are:
(table of tested
drugs removed for
clarity)
Simulated Gastric
Acid Fluid was also
tested with a
minimum
breakthrough
greater than 240
minutes.

WARNING:
Please note the
following drugs
have extremely low
permeation times:
Carmustine: 15.8
minutes and
Thiotepa: 24.6
minutes. Do not use
with Carmustine
and Thiotepa. | |
| --- | --- | --- | --- |
| Material | Synthetic
polyisoprene rubber | Synthetic
polyisoprene rubber | Similar |
| Coating | Synthetic polymeric
inner coating | Synthetic polymeric
inner coating | Similar |
| Design | Single use | Single use | Same |
| Design | Powder-free | Powder-free | Same |
| Design | Anatomical shape
with curved fingers | Anatomical shape
with curved fingers | Same |
| Design | Beaded cuff | Beaded cuff | Same |
| Color | Natural color | Green | Different |
| Labeling | Surgeon's Gloves | Surgeon's Gloves | Similar |
| Shelf Life | Not specified | No claimed shelf
life | Similar |

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| Sterility Assurance Level | 10^{-6} | 10^{-6} | Same |
| --- | --- | --- | --- |
| Sterilization Modality | Not specified | Radiation | Different |
| Surgical Glove ASTM D3577 | Meets requirements | Meets requirements | Same |
| Dimensions ASTM D3577 | 5½, 6, 6½, 7, 7½, 8, 8½, and 9 | 5½, 6, 6½, 7, 7½, 8, 8½, and 9 | Same |
| Tensile Strength Before Aging ASTM D3577 | 17 MPa min | 17 MPa min | Same |
| Ultimate Elongation Before Aging ASTM D3577 | 650% min | 650% min | Same |
| Stress at 500% Elongation Before Aging | 7.0 MPa min | 7.0 MPa min | Same |
| Tensile Strength After Aging ASTM D3577 | 12 MPa min | 12 MPa min | Same |
| Ultimate Elongation After Aging | 490 % min | 490 % min | Same |
| Residual Powder ASTM D6124 | Does not exceed 2 mg/glove | Does not exceed 2 mg/glove | Same |
| Freedom From Holes ASTM D5151 | Meets ASTM D3577 requirements | Meets ASTM D3577 requirements | Same |
| Biocompatibility In Vitro Cytotoxicity ISO 10993-5 | Not specified | Under the conditions of the study, failed with cytotoxicity grade 4 | Same |
| Biocompatibility Primary Skin Irritation ISO 10993-10 | Under the conditions of the study, the device is not an irritant. | Under the conditions of the study, the device is not an irritant. | Same |
| Biocompatibility Dermal Sensitization - ISO 10993-10 | Under the conditions of the study, the device is a non-sensitizer. | Under the conditions of the study, the device is a non-sensitizer. | Same |
| Biocompatibility Systemic Toxicity ISO 10993-11 | Not specified | Under the conditions of the study, the device does not exhibit | Different |

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| | | acute systemic toxicity. | |
| --- | --- | --- | --- |
| Biocompatibility Material Mediated Toxicity ISO 10993-11:2017 | Not specified | Under the conditions of the study, no pyrogenic response was observed. | Different |
| Biocompatibility Bacterial Endotoxins Test USP <85> | Not specified | Under conditions of the study, less than 20 EU/device | Different |

## Comparison Between Predicate and Proposed:

Differences in Trade Name, 510k Number, Product Owner, Color, and Sterilization Modality do not directly affect the performance or use of the devices.

Chemotherapy Testing: The predicate device was not tested for permeation of chemotherapy drugs or gastric acid. The safety and efficacy of the proposed device with respect to chemotherapy drugs and gastric acid is addressed through the performance testing and labeling of the device.

Shelf Life: There is no claimed shelf life for the proposed device.

The subject and predicate devices meet the applicable requirements for surgeon's gloves with regards to dimensions and sizes, physical properties, freedom from holes, and powder residues as found in the following standards: ASTM D3577, ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity in accord with the ISO 10993 series of standards.

## Non-Clinical Testing

Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid has the following technological characteristics as compared to ASTM or equivalent standards:

| Title of Test | Purpose of Test | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| ASTM D3577-19 | Dimensions | Meets criteria in accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves | PASS |
| ASTM D3577-19 | Physical Properties | Meets criteria for tensile strength, ultimate elongation and stress at 500% elongation before and after accelerated aging for synthetic surgical | PASS |

Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

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| | | gloves per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves | |
| --- | --- | --- | --- |
| ASTM D5151-19 | Freedom from holes | Meets criteria in accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves with AQL requirements of 0.65 | PASS |
| ASTM D6124 | Powder-Free | Meets applicable acceptance criteria for powder free ≤ 2mg per glove per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves | PASS |
| ISO 11137-1:2006 | Sterility | Meets acceptance criteria requirement of 10^{-6} SAL per ISO 11137-1: Sterilization for health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | PASS |
| ASTM D6978-05 | Chemotherapy Drug Permeation Test | Testing performed in accordance with ASTM D6978-05: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | PASS |
| ISO 10993-10:2010 | Biocompatibility: Skin Irritation | Passes Primary Skin Irritation test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization. Under the conditions of the study, not an irritant. | PASS |
| ISO 10993-10:2010 | Biocompatibility: Dermal Sensitization | Passes Dermal Sensitization test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization. Under the conditions of the study, not a sensitizer. | PASS |

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| ISO 10993-11:2017 | Biocompatibility: Acute Systemic Toxicity | Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity. Under the conditions of the study, there was no mortality or evidence of acute systemic toxicity. | PASS |
| --- | --- | --- | --- |
| ISO 10993-11:2017 | Biocompatibility: Material-Mediated Pyrogenicity | Passes Material-Mediated Pyrogenicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity. Under the conditions of the study, no pyrogenic response was observed. | PASS |
| USP <85> | Endotoxin Testing | Meets acceptance criteria for bacterial endotoxins per USP <85> Bacterial Endotoxins Test. Endotoxin level ≤ 20 EU/device. | PASS |

## Clinical Studies

A clinical study was not conducted in support of this submission.

## Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K160781.

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