(92 days)
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff, is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff, are disposable, single-use, sterile, blue-colored, and powder-free examination gloves made from nitrile latex.
The provided FDA 510(k) clearance letter pertains to medical examination gloves, not an AI-powered medical device. Therefore, the document does not contain information about the acceptance criteria and study proving an AI device meets those criteria.
The information typically found in such a submission would include:
- Device performance: This document explicitly states the "Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)" has been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
- Acceptance Criteria/Performance Data: The acceptance criteria for the gloves are based on relevant ASTM standards for physical properties, barrier integrity, and biocompatibility. The chemotherapy drug resistance is presented as "Minimum Breakthrough Detection Time in Minutes."
- Study Design (Non-Clinical): The studies are non-clinical, primarily laboratory-based physical and chemical tests compliant with recognized international and national standards (e.g., ASTM, ISO).
- Ground Truth: For these types of devices, the "ground truth" is typically defined by quantifiable physical and chemical properties measured against established standard methods (e.g., measuring milligrams of residual powder, breakthrough time of chemicals). There are no human experts, adjudication, or training/test sets in the context of AI for this type of device.
Given this, I cannot extract the information required for an AI-powered device from this document. The sections you asked for (sample size for test/training, expert qualifications, MRMC studies, standalone performance, etc.) are specific to AI/software as a medical device (SaMD) assessments and are not present in a submission for examination gloves.
However, I can summarize the acceptance criteria and reported performance for the examination gloves as provided in the document:
Acceptance Criteria and Reported Device Performance (for Examination Gloves)
This table summarizes the non-clinical acceptance criteria and the "result" or reported performance for the Sterile Nitrile Powder Free Examination Gloves.
| Test / Characteristic | Acceptance Criteria / Standard Reference | Reported Device Performance |
|---|---|---|
| Freedom from holes | Meets ASTM D5151-19 (R2023): AQL 1.5% | Pass |
| Residual Powder | Meets ASTM D6124-06 (R2022): Average less than 2 mg/glove | Pass |
| Dimensions (Length) | Meets ASTM D6319-19 (R2023): Overall Length: ≥ 230 mm (Subject Device 1); ≥ 260 mm (Subject Device 2) | Pass (Conforms to ASTM D6319 width, thickness, and length requirements) |
| Dimensions (Width) | Meets ASTM D6319-19 (R2023): Specific ranges for XS, S, M, L, XL | Pass (Conforms to ASTM D6319 width, thickness, and length requirements) |
| Dimensions (Thickness) | Meets ASTM D6319-19 (R2023): Palm Thickness: ≥ 0.05 mm; Finger Thickness: ≥ 0.05 mm | Pass (Conforms to ASTM D6319 width, thickness, and length requirements) |
| Tensile Strength Before Aging | Meets ASTM D6319-19 (R2023): ≥ 14 MPa | Pass (Conforms) |
| Tensile Strength After Aging | Meets ASTM D6319-19 (R2023): ≥ 14 MPa | Pass (Conforms) |
| Ultimate Elongation Before Aging | Meets ASTM D6319-19 (R2023): ≥ 500 % | Pass (Conforms) |
| Ultimate Elongation After Aging | Meets ASTM D6319-19 (R2023): ≥ 400 % | Pass (Conforms) |
| Primary Skin Irritation | ISO 10993-23: Not an irritant | Under the conditions of the study, not an irritant. |
| Dermal Sensitization | ISO 10993-10: Not a sensitizer | Under the conditions of the study, not a sensitizer. |
| Acute Systemic Toxicity | ISO 10993-11: No evidence of acute systemic toxicity | Under the conditions of this study, no acute systemic toxicity. |
| Chemotherapy Drug Permeation | ASTM D6978 (No specific 'Pass/Fail' criterion listed, rather minimum breakthrough times are reported.) | Listed in table below. |
| Fentanyl Citrate Permeation | ASTM D6978 (No specific 'Pass/Fail' criterion listed, rather minimum breakthrough times are reported.) | > 240 minutes |
Chemotherapy Drug and Fentanyl Citrate Permeation Results
Device Performance (Minimum Breakthrough Detection Time in Minutes)
| Chemotherapy Drug and Concentration | Subject Device Result |
|---|---|
| Carmustine (3.3 mg/ml) | 38.3 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin HCl (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 78.6 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| Vidaza (5-Azacytidine), 25 mg/ml | > 240 |
| Busulfan, 6 mg/ml | > 240 |
| Carboplatin, 10 mg/ml | > 240 |
| Docetaxel, 10 mg/ml | > 240 |
| Epirubicin HCl, 2 mg/ml | > 240 |
| Gemcitabine HCl, 38 mg/ml | > 240 |
| Ifosfamide, 50 mg/ml | > 240 |
| Irinotecan, 20 mg/ml | > 240 |
| Mitoxantrone HCl, 2 mg/ml | > 240 |
| Oxaliplatin, 5 mg/ml | > 240 |
| Vinorelbine, 10 mg/ml | > 240 |
| Fentanyl Citrate Injection (100mcg/2ml) | > 240 |
Since the provided document is not for an AI device, the following points cannot be addressed:
- Sample sized used for the test set and the data provenance: Not applicable to a physical glove.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves is based on physical/chemical measurements by laboratory technicians following standard protocols.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For gloves, it's objective physical/chemical measurements according to ASTM/ISO standards.
- The sample size for the training set: Not applicable (no AI training involved).
- How the ground truth for the training set was established: Not applicable.
FDA 510(k) Clearance Letter - K251319
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 30, 2025
Hartalega NGC Sdn. Bhd.
Mahalia Liyana Mat Harun
Manager - Regulatory Affairs
No. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung
Sepang, Selangor Darul Ehsan 43900
Malaysia
Re: K251319
Trade/Device Name: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-powdered patient examination glove
Regulatory Class: Class I, reserved
Product Code: LZA, LZC, OPJ, QDO
Dated: July 3, 2025
Received: July 3, 2025
Dear Mahalia Liyana Mat Harun:
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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K251319 - Mahalia Liyana Mat Harun 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-
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K251319 - Mahalia Liyana Mat Harun 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K251319
Device Name
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue);
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff
Indications for Use (Describe)
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff, is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 38.3 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin HCl (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 78.6 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| Vidaza (5-Azacytidine), 25 mg/ml | >240 |
| Busulfan, 6 mg/ml | >240 |
| Carboplatin, 10 mg/ml | >240 |
| Docetaxel, 10 mg/ml | >240 |
| Epirubicin HCl, 2 mg/ml | >240 |
| Gemcitabine HCl, 38 mg/ml | >240 |
| Ifosfamide, 50 mg/ml | >240 |
| Irinotecan, 20 mg/ml | >240 |
| Mitoxantrone HCl, 2 mg/ml | >240 |
| Oxaliplatin, 5 mg/ml | >240 |
| Vinorelbine, 10 mg/ml | >240 |
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100mcg/2ml) | >240 |
Caution: Testing showed a minimum breakthrough time of 38.3 minutes with Carmustine and 78.6 minutes with Thiotepa.
Warning: Do not use with Carmustine
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)
FORM FDA 3881 (8/23) Page 1 of 2
Page 5
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
"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."
FORM FDA 3881 (8/23) Page 2 of 2
Page 6
K251319
Page 1 of 8
510(k) SUMMARY FOR K251319
(The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92)
APPLICANT INFORMATION
Date Prepared: July 29, 2025
Name: Hartalega NGC Sdn. Bhd.
Address: No. 1, Persiaran Tanjung,
Kawasan Perindustrian Tanjung,
43900 Sepang, Selangor Darul Ehsan,
Malaysia
Establishment Registration Number: 3011200663
CORRESPONDENT AND/OR PREPARER INFORMATION
Contact Name: Mahalia Liyana Mat Harun
Contact Title: Manager – Regulatory Affairs
Phone Number: (603) 8707 3000
Fax Number: (603) 3271 0135
Contact Email: liyana.harun@hartalega.com.my
DEVICE IDENTIFICATION
Common Name of the Device: Examination Glove
Trade Name (Proprietary Name): Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue),
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff
Device Class: 1
Product Code: LZA, LZC, QDO, OPJ
Regulation Number: 21 CFR 880.6250
Reason for 510(k) Submission: New device
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K251319
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PREDICATE DEVICE INFORMATION
510(k) Number: K201531
Manufacturer: Hartalega Sdn. Bhd.
Trade Name (Proprietary Name): Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Device Class: 1
Product Code: LZA, LZC
Regulation Number: 21 CFR 880.6250
DESCRIPTION OF THE DEVICE:
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff, are disposable, single-use, sterile, blue-colored, and powder-free examination gloves made from nitrile latex.
INDICATIONS FOR USE:
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff, is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 38.3 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin HCl (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 78.6 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| Vidaza (5-Azacytidine), 25 mg/ml | > 240 |
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K251319
Page 3 of 8
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Busulfan, 6 mg/ml | > 240 |
| Carboplatin, 10 mg/ml | > 240 |
| Docetaxel, 10 mg/ml | > 240 |
| Epirubicin HCl, 2 mg/ml | > 240 |
| Gemcitabine HCl, 38 mg/ml | > 240 |
| Ifosfamide, 50 mg/ml | > 240 |
| Irinotecan, 20 mg/ml | > 240 |
| Mitoxantrone HCl, 2 mg/ml | > 240 |
| Oxaliplatin, 5 mg/ml | > 240 |
| Vinorelbine, 10 mg/ml | > 240 |
Caution: Testing showed a minimum breakthrough time of 38.3 minutes with Carmustine and 78.6 minutes with Thiotepa.
Warning: Do not use with Carmustine.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection, 100 mcg/2ml | > 240 |
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K251319
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TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE:
| Characteristics and Parameters | Subject Device (1) | Subject Device (2) | Predicate Device (K201531) | Discussion |
|---|---|---|---|---|
| Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff | |||
| Trade Name | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Similar |
| Applicant | Hartalega NGC Sdn. Bhd. | Hartalega Sdn. Bhd. | Different | |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Same | |
| Classification | 1 | 1 | Same | |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | |
| Regulation Name | Non-Powdered Patient Examination Glove | Non-Powdered Patient Examination Glove | Same | |
| Indications for Use | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff, is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | A sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate. | Same |
Chemotherapy Drug Testing Results
Subject Device:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 38.3 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin HCl (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 78.6 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| Vidaza (5-Azacytidine), 25 mg/ml | > 240 |
| Busulfan, 6 mg/ml | > 240 |
| Carboplatin, 10 mg/ml | > 240 |
| Docetaxel, 10 mg/ml | > 240 |
| Epirubicin HCl, 2 mg/ml | > 240 |
| Gemcitabine HCl, 38 mg/ml | > 240 |
| Ifosfamide, 50 mg/ml | > 240 |
| Irinotecan, 20 mg/ml | > 240 |
| Mitoxantrone HCl, 2 mg/ml | > 240 |
Predicate Device:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 26.3 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin HCl (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
Discussion: The performance level for Carmustine and Thiotepa between subject device and predicate device is comparable. An additional 11 chemotherapy drugs were tested on the subject device.
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K251319
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| Characteristics and Parameters | Subject Device (1) | Subject Device (2) | Predicate Device (K201531) | Discussion |
|---|---|---|---|---|
| Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff |
Continued Chemotherapy Testing:
| | | | Thiotepa (10.0 mg/ml) | 97.1 |
| | | | Vincristine Sulfate (1.0 mg/ml) | > 240 |
Predicate Device Caution/Warning:
Caution: Please note that Carmustine and Thiotepa have extremely low permeation times of 26.3 minutes and 97.1 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa
Subject Device:
Oxaliplatin, 5 mg/ml > 240
Vinorelbine, 10 mg/ml > 240
Caution: Testing showed a minimum breakthrough time of 38.3 minutes with Carmustine and 78.6 minutes with Thiotepa.
Warning: Do not use with Carmustine.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100mcg/2ml) | > 240 |
Predicate Device:
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100mcg/2ml) | > 240 |
Discussion: Same
| Type of use | Over the counter use | | Over the counter use | Same |
| Materials | Nitrile | | Nitrile | Same |
| Color | Blue | | Blue | Same |
| Design | • Single Use• Sterile• Powder-Free• Ambidextrous | | • Single Use• Sterile• Powder-Free• Ambidextrous | Same |
| Sterility | Sterile | | Sterile | Same |
| Sterilization | Radiation | | Radiation | Same |
| Sterility Assurance Level (SAL) | 10⁻⁶ SAL | | 10⁻⁶ SAL | Same |
| Freedom from holes | Meets ASTM D5151-19 (2023): AQL 1.5 | | Meets ASTM D5151-06(2015): AQL 1.5 | Similar |
| Length | Meets ASTM D6319-19 (2023): Overall Length: ≥ 230 mm | Meets ASTM D6319-19 (2023): Overall Length: ≥ 260 mm | Meets ASTM D6319-10 (2015): Overall Length: ≥ 230 mm | Both subject devices meet the overall length specification in accordance with ASTM D6319. Subject Device (2) features an extended cuff design, with a minimum length of 260 mm, compared to 230 mm for the predicate device. This dimensional difference does not impact the safety or performance of the subject device, as all devices comply with |
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K251319
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| Characteristics and Parameters | Subject Device (1) | Subject Device (2) | Predicate Device (K201531) | Discussion |
|---|---|---|---|---|
| Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff |
Length (continued):
| | | | Thiotepa (10.0 mg/ml) | 97.1 |
| | | | Vincristine Sulfate (1.0 mg/ml) | > 240 |
Caution: Testing showed a minimum breakthrough time of 38.3 minutes with Carmustine and 78.6 minutes with Thiotepa.
Warning: Do not use with Carmustine.
Caution: Please note that Carmustine and Thiotepa have extremely low permeation times of 26.3 minutes and 97.1 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100mcg/2ml) | > 240 |
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100mcg/2ml) | > 240 |
Discussion: Same
| Type of use | Over the counter use | | Over the counter use | Same |
| Materials | Nitrile | | Nitrile | Same |
| Color | Blue | | Blue | Same |
| Design | • Single Use• Sterile• Powder-Free• Ambidextrous | | • Single Use• Sterile• Powder-Free• Ambidextrous | Same |
| Sterility | Sterile | | Sterile | Same |
| Sterilization | Radiation | | Radiation | Same |
| Sterility Assurance Level (SAL) | 10⁻⁶ SAL | | 10⁻⁶ SAL | Same |
| Freedom from holes | Meets ASTM D5151-19 (2023): AQL 1.5 | | Meets ASTM D5151-06(2015): AQL 1.5 | Similar |
| Length | Meets ASTM D6319-19 (2023): Overall Length: ≥ 230 mm | Meets ASTM D6319-19 (2023): Overall Length: ≥ 260 mm | Meets ASTM D6319-10 (2015): Overall Length: ≥ 230 mm | Both subject devices meet the overall length specification in accordance with ASTM D6319. Subject Device (2) features an extended cuff design, with a minimum length of 260 mm, compared to 230 mm for the predicate device. This dimensional difference does not impact the safety or performance of the subject device, as all devices comply with applicable standard requirements. |
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| Characteristics and Parameters | Subject Device (1) | Subject Device (2) | Predicate Device (K201531) | Discussion |
|---|---|---|---|---|
| Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff |
Length (continued): applicable standard requirements.
| Width | Meets ASTM D6319-19 (2023):XS: 60 − 80 (mm)S: 70 − 90 (mm)M: 85 − 105 (mm)L: 100 − 120 (mm)XL: 110 − 130 (mm) | | Meets ASTM D6319-10 (2015):XS: 60 − 80 (mm)S: 70 − 90 (mm)M: 85 − 105 (mm)L: 100 − 120 (mm)XL: 110 − 130 (mm) | Similar |
| Thickness | Meets ASTM D6319-19 (2023):Palm Thickness: ≥ 0.05 mmFinger Thickness: ≥ 0.05 mm | | Meets ASTM D6319-10 (2015):Palm Thickness: ≥ 0.05 mmFinger Thickness: ≥ 0.05 mm | Similar |
| Physical Properties | Meets ASTM D6319-19 (2023):Tensile Strength Before Aging: ≥ 14 MPaTensile Strength After Aging: ≥ 14 MPaUltimate Elongation Before Aging: ≥ 500 %Ultimate Elongation After Aging: ≥ 400 % | | Meets ASTM D6319-10 (2015):Tensile Strength Before Aging: ≥ 14 MPaTensile Strength After Aging: ≥ 14 MPaUltimate Elongation Before Aging: ≥ 500 %Ultimate Elongation After Aging: ≥ 400 % | Similar |
| Powder residual | Meets ASTM D6319-19 (2023) & ASTM D6124-06 (2017):Residual Powder: ≤ 2 mg per glove | | Meets ASTM D6124-06 (2017):Residual Powder: ≤ 2 mg per glove | Similar |
| Primary Skin Irritation | ISO 10993-23Under the conditions of the study, the device is not an irritant | | Under the conditions of the study, the device is not an irritant | Same |
| Dermal Sensitization | ISO 10993-10Under the conditions of the study, the device is not a sensitizer | | Under the conditions of the study, the device is not a sensitizer | Same |
| Acute Systemic Toxicity Test | ISO 10993-11Under the conditions of this study, the device showed no evidence of acute systemic toxicity | | Under the conditions of this study, the device showed no evidence of acute systemic toxicity | Same |
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SUMMARY OF NON-CLINICAL TESTING:
Non-clinical testing was performed to verify that the subject devices meet the acceptance criteria of the performance test and all design specifications. The test results demonstrated that the subject device complies with the following standards as shown below.
| Test | Purpose | Criteria | Result |
|---|---|---|---|
| Standard Test Method for Detection of Holes in Medical GlovesASTM D5151-19(R2023) | To demonstrate glove integrity | Freedom from holesAQL 1.5% | Pass |
| Standard Test Method for Residual Powder on Medical GlovesASTM D6124-06(R2022) | To demonstrate the gloves are 'powder free' | Average less than 2 mg/glove | Pass |
| Dimensional ConformanceASTM D6319(R2023) | To demonstrate appropriate dimensions for labeled sizes | Conforms to ASTM D6319 width, thickness, and length requirements for XS, S, M, L, and XLAQL 4% | Pass |
| Tensile PerformanceASTM D6319(R2023) | To demonstrate adequate tensile properties | Conforms to ASTM D6319 tensile strength of at least 14MPa and ultimate elongation of at least 500% requirements prior to aging, and tensile strength of at least 14MPa and ultimate strength of at least 400% after accelerated agingAQL 4% | Pass |
| Biocompatibility: Skin IrritationISO 10993-23 | To demonstrate low potential for skin irritation | Under the conditions of the study, not an irritant. | Pass |
| Biocompatibility: Skin SensitizationISO 10993-10 | To demonstrate low potential for skin sensitization | Under the conditions of the study, not a sensitizer | Pass |
| Biocompatibility: Acute Systemic ToxicityISO 10993-11 | To demonstrate low acute systemic toxicity | Under the conditions of the study, no acute systemic toxicity. | Pass |
| ASTM D6978Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs | To demonstrate barrier properties of gloves to permeation of chemotherapy drugs and fentanyl citrate:Carmustine (3.3 mg/ml)Cisplatin (1 mg/ml)Cyclophosphamide (20 mg/ml)Dacarbazine (10 mg/ml)Doxorubicin HCl (2 mg/ml)Etoposide (20 mg/ml)Fluorouracil (50 mg/ml)Methotrexate (25 mg/ml)Mitomycin C (0.5 mg/ml)Paclitaxel (6 mg/ml)Thiotepa (10 mg/ml)Vincristine Sulfate (1 mg/ml)Vidaza (5-Azacytidine), 25 mg/mlBusulfan, 6 mg/mlCarboplatin, 10 mg/mlDocetaxel, 10 mg/mlEpirubicin HCl, 2 mg/ml | N/A | CarmustineMinimum breakthrough time: 38.3 minutesThiotepaMinimum breakthrough time: 78.6 minutesNo breakthrough detected during 240-minute test duration for remaining tested chemotherapy drugs and fentanyl citrate |
Continued testing includes:
- Gemcitabine HCl, 38 mg/ml
- Ifosfamide, 50 mg/ml
- Irinotecan, 20 mg/ml
- Mitoxantrone HCl, 2 mg/ml
- Oxaliplatin, 5 mg/ml
- Vinorelbine, 10 mg/ml
- Fentanyl Citrate Injection, 100 mcg/2mL
CLINICAL PERFORMANCE DATA:
Not applicable.
CONCLUSION:
The conclusions drawn from the non-clinical testing demonstrates that the subject devices (Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff) are as safe, as effective and perform as well as or better than the legally marketed predicate device K201531, Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue).
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.