(197 days)
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.
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.
The provided document is a 510(k) clearance letter from the FDA for a medical device: "Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid." This document outlines the general requirements for the device and details the non-clinical testing performed to establish substantial equivalence to a predicate device.
However, it does not contain any information regarding clinical studies, AI/ML device performance, or human-in-the-loop studies. The device is a physical medical glove and not an AI-powered diagnostic or assistive tool. Therefore, the requested information elements related to AI/ML and clinical study methodologies are not applicable to this submission.
The document focuses on demonstrating the physical, chemical, and biological safety and performance of the gloves according to recognized consensus standards.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The device underwent non-clinical testing against several recognized standards. The "Results" column consistently states "PASS," indicating that the device met the specified acceptance criteria for each test.
| Title of Test | Purpose of Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 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 gloves per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves | PASS |
| 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 |
| 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 |
Chemotherapy Drug Permeation Results:
| 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 |
| Stomach Acid | >240 |
Warning: Carmustine: 15.8 minutes and Thiotepa: 24.6 minutes. Do not use with Carmustine and Thiotepa.
Summary of Study Information (Not Applicable for this Device Type)
The provided document describes a Class I medical device (Sterile Powder Free Synthetic Rubber Surgeon's Gloves) which is a physical product, not a software device or an AI/ML-driven system. Therefore, the following requested information points related to AI/ML device performance and clinical study methodologies are not applicable. The submission primarily relied on non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device tested via non-clinical laboratory methods according to recognized standards (e.g., ASTM, ISO). The specific sample sizes for each non-clinical test (e.g., number of gloves for tensile strength, number of samples for permeation, number of animals for biocompatibility) are part of the detailed test reports but are not summarized in this FDA summary document. Data provenance details like country of origin for test materials or retrospective/prospective nature are not specified as they are not relevant for this type of non-clinical testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of expert consensus is typically relevant for diagnostic AI/ML devices interpreting medical images or other complex data. For gloves, "ground truth" is established by adherence to quantitative physical, chemical, and biological performance standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical trials or expert review panels, not for standard physical/chemical testing of a device like a glove.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI system nor does it involve human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" is adherence to the specified performance criteria defined by the listed consensus standards (e.g., ASTM D3577 for physical properties, ASTM D6978 for chemotherapy permeation, ISO 10993 for biocompatibility). These standards define acceptable quantitative limits or qualitative responses (e.g., "not an irritant").
- The sample size for the training set: Not applicable. This device does not involve a "training set" as it is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This device does not involve a "training set."
Conclusion:
The FDA document K250313 confirms the clearance of sterile surgeon's gloves based on their adherence to established non-clinical performance and safety standards, including physical properties, sterility, and resistance to chemotherapy drugs and gastric acid. The document explicitly states that "[a] clinical study was not conducted in support of this submission." The questions related to AI/ML, clinical study designs, expert ground truth, and training data are not relevant to this specific device submission.
FDA 510(k) Clearance Letter - K250313
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
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.
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K250313 - Jay Mansour Page 2
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-
Page 3
K250313 - Jay Mansour Page 3
assistance/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,
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
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.
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FORM FDA 3881 (8/23) Page 2 of 2
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.
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Page 6
510K Summary
HARPS Europe Manufacturing GmbH K250313
Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
1 of 8
510(k) Number: K250313
Submitter: HARPS Europe Manufacturing GmbH
TRIESTER BUNDESSTRASSE 26
WIMPASSING NIEDEROSTERREICH
Niederosterreich 2632
Austria
Contact Person(s): Dr. Alexander Weinert
Phone: +43676850868240
Email: alexander.weinert@harpsglobal.com
Correspondent: Mansour Consulting LLC
845 Aronson Lake Court
Roswell GA 30075
United States
Mr. Jay Mansour
Phone: 6789088180
Email: jay@mansourconsulting.com
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
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HARPS Europe Manufacturing GmbH K250313
Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
2 of 8
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 |
Page 8
HARPS Europe Manufacturing GmbH K250313
Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
3 of 8
| 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 |
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HARPS Europe Manufacturing GmbH K250313
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 |
| Sterilization Modality | Not specified | Radiation |
| Surgical Glove ASTM D3577 | Meets requirements | Meets requirements |
| Dimensions ASTM D3577 | 5½, 6, 6½, 7, 7½, 8, 8½, and 9 | 5½, 6, 6½, 7, 7½, 8, 8½, and 9 |
| Tensile Strength Before Aging ASTM D3577 | 17 MPa min | 17 MPa min |
| Ultimate Elongation Before Aging ASTM D3577 | 650% min | 650% min |
| Stress at 500% Elongation Before Aging | 7.0 MPa min | 7.0 MPa min |
| Tensile Strength After Aging ASTM D3577 | 12 MPa min | 12 MPa min |
| Ultimate Elongation After Aging | 490 % min | 490 % min |
| Residual Powder ASTM D6124 | Does not exceed 2 mg/glove | Does not exceed 2 mg/glove |
| Freedom From Holes ASTM D5151 | Meets ASTM D3577 requirements | Meets ASTM D3577 requirements |
| Biocompatibility In Vitro Cytotoxicity ISO 10993-5 | Not specified | Under the conditions of the study, failed with cytotoxicity grade 4 |
| 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. |
| 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. |
| Biocompatibility Systemic Toxicity ISO 10993-11 | Not specified | Under the conditions of the study, the device does not exhibit |
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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 |
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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.
§ 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).