(80 days)
No.
The device is a pair of medical gloves; it is a passive physical barrier and does not contain any computational or interactive components.
No
The device is a medical exam glove, intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
Explanation:
The device is described as "Nitrile Powder-Free Exam Gloves," which are intended to prevent contamination between patient and examiner. The description details physical properties and resistance to chemicals, but there is no indication that the gloves are used to diagnose medical conditions or provide information for diagnosis.
No
The device is a physical product (nitrile gloves) and the summary describes its material, dimensions, and physical performance testing. It does not mention any software components.
No.
This device, a glove, is intended for physical protection to prevent contamination between patient and examiner. It is not designed to perform in vitro diagnostic testing on specimens derived from the human body.
N/A
Intended Use / Indications for Use
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl, Gastric acid and Xylazine in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Product codes
LZA, LZC, OPJ, QDO
Device Description
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, blue colored nitrile gloves featuring an inner coating of hyaluronic acid and single use only. There are six different sizes- XS, S, M, L, XL and XXL.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs, opioid Fentanyl Citrate, simulated Gastric Acid and Xylazine per ASTM D6978-05.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical purposes, examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility
Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the proposed device is Surface and External Communicating Device and duration of contact is A-Limited (
§ 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.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 22, 2025
Basic Medical Technology Inc.
John Zhao
General Manager
5300 Concours Street
Ontario, California 91764
Re: K250630
Trade/Device Name: Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
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: March 3, 2025
Received: March 3, 2025
Dear John Zhao:
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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K250630 - John Zhao 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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K250630 - John Zhao 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)
K250630
Device Name
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
Indications for Use (Describe)
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl, Gastric acid and Xylazine in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
| Chemotherapy Drugs | Minimum Breakthrough Detection Time |
|---|---|
| Carboplatin, 10 mg/ml | >240 min. |
| Carmustine, 3.3 mg/ml | 11.6 min. |
| Cisplatin, 1 mg/ml | >240 min. |
| Cyclophosphamide, 20 mg/ml | >240 min. |
| Cytarabine HCl 100 mg/ml | >240 min. |
| Dacarbazine, 10 mg/ml | >240 min. |
| Daunorubicin HCl, 5 mg/ml | >240 min. |
| Doxorubicin HCl, 2 mg/ml | >240 min. |
| Etoposide, 20 mg/ml | >240 min. |
| 5-Fluorouracil, 50 mg/ml | >240 min. |
| Gemcitabine HCl, 38 mg/ml | >240 min. |
| Idarubicin HCl, 1 mg/ml | >240 min. |
| Ifosfamide, 50 mg/ml | >240 min. |
| Irinotecan HCl, 20 mg/ml | >240 min. |
| Mechlorethamine HCl, 1 mg/ml | >240 min. |
| Melphalan HCl, 5 mg/ml | >240 min. |
| Methotrexate, 25 mg/ml | >240 min. |
| Mitomycin-C, 0.5 mg/ml | >240 min. |
| Mitoxantrone HCl, 2 mg/ml | >240 min. |
| Paclitaxel, 6 mg/ml | >240 min. |
| Thiotepa, 10 mg/ml | 25.3 min. |
| Vincristine Sulfate,1 mg/ml | >240 min. |
| Fentanyl, Gastric Acid and Xylazine | Minimum Breakthrough Detection Time |
|---|---|
| Fentanyl Citrate Injection, 50mcg/ml | >240 min. |
| Simulated Gastric Acid | >240 min. |
| Fentanyl Citrate (50mcg/ml): Xylazine HCl(100mg/ml), 50:50 | >240 min. |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 11.6 minutes, Thiotepa:25.3 minutes
Warning: 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)
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
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"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
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510(k) Summary
1. Submission Information
Date Prepared: May 21, 2025
Submission Format: Traditional 510(k)
510(K)#: K250630
2. Submitter Information
Applicant Name: Basic Medical Technology Inc.
Address: 5300 Concours Ontario, CA 91764
Contact Person: John Zhao
Tel: (909) 980-1678
Email: hotmailtojohn@yahoo.com
3. Device Information
Trade Name: Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
Common Name: Nitrile Powder-Free Exam Gloves
Classification Name: Non-Powdered Patient Examination Glove
Regulation: 21 CFR 880.6250
Product Code: LZA, LZC, QDO, OPJ
Classification Panel: General Hospital
Device Class: Class I
4. Predicate Device Information
Primary Predicate Device:
Applicant: Anhui Intco Medical Products Co., Ltd.
510(k) #: K231365
Trade Name: Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate. Aka Synguard C+ Nitrile Exam Gloves
Reference Device 1:
Applicant: Basic Medical Technology Inc.
510(k) #: K243441
Trade Name: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)
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Reference Device 2:
Applicant: Ever Global (Vietnam) Enterprise Corporation
510(k) #: K244034
Trade Name: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate And Xylazine
5. Device Description:
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, blue colored nitrile gloves featuring an inner coating of hyaluronic acid and single use only. There are six different sizes- XS, S, M, L, XL and XXL.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs, opioid Fentanyl Citrate, simulated Gastric Acid and Xylazine per ASTM D6978-05.
6. Indications for Use:
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves were tested for use with Chemotherapy drugs, Fentanyl, Gastric acid and Xylazine in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
| NO. | Chemotherapy Drugs | Minimum Breakthrough Detection Time |
|---|---|---|
| 1 | Carboplatin, 10 mg/ml | >240 min |
| 2 | Carmustine, 3.3 mg/ml | 11.6 min |
| 3 | Cisplatin, 1 mg/ml | >240 min |
| 4 | Cyclophosphamide, 20 mg/ml | >240 min |
| 5 | Cytarabine HCl, 100 mg/ml | >240 min |
| 6 | Dacarbazine, 10 mg/ml | >240 min |
| 7 | Daunorubicin HCl, 5 mg/ml | >240 min |
| 8 | Doxorubicin HCl, 2 mg/ml | >240 min |
| 9 | Etoposide, 20 mg/ml | >240 min |
| 10 | 5-Fluorouracil, 50 mg/ml | >240 min |
| 11 | Gemcitabine HCl, 38 mg/ml | >240 min |
| 12 | Idarubicin HCl, 1 mg/ml | >240 min |
| 13 | Ifosfamide, 50 mg/ml | >240 min |
| 14 | Irinotecan HCl, 20 mg/ml | >240 min |
| 15 | Mechlorethamine HCl, 1 mg/ml | >240 min |
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| 16 | Melphalan HCl, 5 mg/ml | >240 min |
| 17 | Methotrexate, 25 mg/ml | >240 min |
| 18 | Mitomycin-C, 0.5 mg/ml | >240 min |
| 19 | Mitoxantrone HCl, 2 mg/ml | >240 min |
| 20 | Pacilitaxel, 6 mg/ml | >240 min |
| 21 | Thiotepa, 10 mg/ml | 25.3 min |
| 22 | Vincristine Sulfate, 1 mg/ml | >240 min |
| NO. | Fentanyl, Gastric Acid and Xylazine | Minimum Breakthrough Detection Time |
|---|---|---|
| 1 | Fentanyl Citrate Injection, 50mcg/ml | >240 min. |
| 2 | Simulated Gastric Acid | >240 min. |
| 3 | Fentanyl Citrate (50mcg/ml): Xylazine HCl(100mg/ml), 50:50 | >240 min. |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 11.6 minutes, Thiotepa: 25.3 minutes
Warning: Do not use with Carmustine and Thiotepa.
7. Comparison of Subject Device and Predicate Device:
General Comparison Table:
| Device | Proposed Device | Predicate Device | Reference Device | Reference Device | Result |
|---|---|---|---|---|---|
| 510K # | K250630 | K231365 | K243441 | K244034 | - |
| Applicant Name | Basic Medical Technology Inc. | Anhui Intco Medical Products Co., Ltd. | Basic Medical Technology Inc. | Ever Global (Vietnam) Enterprise Corporation | Same as K243441 |
| Product Name | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate. Aka Synguard C+ Nitrile Exam Gloves | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate And Xylazine | - |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Device Classification | Class I | Class I | Class I | Class I | Same |
| Indications for use | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner's | A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with | A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were | Similar |
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| | hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl, Gastric acid and Xylazine in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs. | The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Chemotherapy drugs, Fentanyl and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs | tested for use with chemotherapy drugs, fentanyl citrate and xylazine in accordance with ASTM D6978-05 standard practice for assessment of Resistance of medical gloves to permeation by chemotherapy drugs. | |
| Powder free | Yes | Yes | Yes | Yes | Same |
| Material | Nitrile | Nitrile | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Light blue, Dark blue | Blue | Similar |
| Size | XS, S, M, L, XL, XXL | XS, S, M, L, XL, XXL | XS, S, M, L, XL, XXL | XS, S, M, L, XL | Similar |
| Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Single Use | Single use | Single use | Single use | Single use | Same |
| Design feature | Ambidextrous | Ambidextrous | Ambidextrous | Ambidextrous | Same |
| Other | Hyaluronic Acid coated on inside | Hyaluronic Acid coated on inside | NA | NA | Same as K231365 |
| Chemo Drugs Claim | See below comparison table | See below comparison table | See below comparison table | See below comparison table | / |
Technological Characteristic Comparison Table:
| Characteristics | Proposed device | Predicate device K231365 | Reference Device K243441 | Reference Device K244034 | Result |
|---|---|---|---|---|---|
| Dimension Reference standard | ASTM D6319-19 | ||||
| Length | Min 220mm for XS, S Min 230mm for M, L, XL, XXL | Min 220mm for XS, S Min 230mm for M, L, XL, XXL | Min 220mm for XS, S Min 230mm for M, L, XL, XXL | Length: Short cuff: ≥ 230mm Long cuff: ≥300mm | Similar |
| Width | XS: 70±10 mm S: 80±10 mm M: 95±10 mm L： 110±10 mm XL：120±10 mm XXL：130±10 mm | XS: 70±10 mm S: 80±10 mm M: 95±10 mm L： 110±10 mm XL：120±10 mm XXL：130±10 mm | XS: 70±10 mm S: 80±10 mm M: 95±10 mm L： 110±10 mm XL：120±10 mm XXL：130±10 mm | XS: 70±10 mm S: 80±10 mm M: 95±10 mm L:110±10 mm XL:120±10 mm | |
| Thickness | Palm: Min 0.05 mm Finger: Min 0.05 mm | Palm: Min 0.05 mm Finger: Min 0.05 mm | Palm: Min 0.05 mm Finger: Min 0.05 mm | Palm: Min 0.05 mm Finger: Min0.05 mm Cuff: Min 0.05 mm | |
| Physical properties Before aging | Same | ||||
| Tensile strength | Min 14MPa | Min 14MPa | Min 14MPa | Min 14MPa |
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| ASTM D6319-19 ASTM D412-16 | Ultimate elongation | Min 500% | Min 500% | Min 500% | Min 500% |
|---|---|---|---|---|---|
| After aging | |||||
| Tensile strength | Min 14MPa | Min 14MPa | Min 14MPa | Min 14MPa | |
| Ultimate elongation | Min 400% | Min 400% | Min 400% | Min 400% | |
| Freedom from holes | ASTM D6319-19; ASTM D5151-19 | G-I, AQL2.5 | G-I, AQL2.5 | G-I, AQL2.5 | G-I, AQL2.5 |
| Residual Powder | ASTM D6319-19; ASTM D6124-06 | ≤ 2 mg per glove | ≤ 2 mg per glove | ≤ 2 mg per glove | ≤ 2 mg per glove |
| Biocompatibility | |||||
| Skin Irritation ISO 10993-23 | Under the conditions of the study, not an irritant | *Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant | Similar |
| Sensitization ISO 10993-10 | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Same |
| Acute Systemic Toxicity Test ISO 10993-11 | Under the conditions of this study, no evidence of acute systemic toxicity. | Under the conditions of this study, no evidence of acute systemic toxicity. | Under the conditions of this study, no evidence of acute systemic toxicity. | Not Performed | Different as K244034 |
| Cytotoxicity ISO 10993-5 | Not Performed | Not Performed | Not Performed | Under the conditions of the study, test article is non-cytotoxic | Different as K244034 |
*The new version of standard for Skin Irritation we refer is ISO 10993-23:2021, the test method and process is the same as the old version ISO 10993-10:2010.
Chemotherapy Drugs Comparison Claim:
| NO. | Chemotherapy Drugs | Minimum Breakthrough Detection Time | Result of comparison | |||
|---|---|---|---|---|---|---|
| Proposed device | Predicate device K231365 ① | Reference Device K243441② | Reference Device K244034③ | |||
| Light blue | Dark blue | |||||
| 1 | Carboplatin, 10 mg/ml | >240 min | / | >240 min | >240 min | >240 min |
| 2 | Carmustine, 3.3 mg/ml | 11.6 min | 12.1 min | 16.6 min | 21.5 min | 21.5 min |
| 3 | Cisplatin, 1 mg/ml | >240 min | >240 min | >240 min | >240 min | >240 min |
| 4 | Cyclophosphamide, 20 mg/ml | >240 min | >240 min | >240 min | >240 min | >240 min |
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| 5 | Cytarabine HCl, 100 mg/ml | >240 min | / | >240 min | >240 min | >240 min | Same as ②and ③ |
| 6 | Dacarbazine, 10 mg/ml | >240 min | >240 min | >240 min | >240 min | >240 min | Same |
| 7 | Daunorubicin HCl, 5 mg/ml | >240 min | / | >240 min | >240 min | >240 min | Same as ②and ③ |
| 8 | Doxorubicin HCl, 2 mg/ml | >240 min | >240 min | >240 min | >240 min | >240 min | Same |
| 9 | Etoposide, 20 mg/ml | >240 min | >240 min | >240 min | >240 min | >240 min | Same |
| 10 | 5-Fluorouracil, 50 mg/ml | >240 min | >240 min | >240 min | >240 min | >240 min | Same |
| 11 | Gemcitabine HCl, 38 mg/ml | >240 min | / | >240 min | >240 min | >240 min | Same as ②and ③ |
| 12 | Idarubicin HCl, 1 mg/ml | >240 min | / | >240 min | >240 min | >240 min | Same as ②and ③ |
| 13 | Ifosfamide, 50 mg/ml | >240 min | / | >240 min | >240 min | >240 min | Same as ②and ③ |
| 14 | Irinotecan HCl, 20 mg/ml | >240 min | / | >240 min | >240 min | >240 min | Same as ②and ③ |
| 15 | Mechlorethamine HCl, 1 mg/ml | >240 min | / | >240 min | >240 min | >240 min | Same as ②and ③ |
| 16 | Melphalan HCl, 5 mg/ml | >240 min | / | >240 min | >240 min | >240 min | Same as ②and ③ |
| 17 | Methotrexate, 25 mg/ml | >240 min | >240 min | >240 min | >240 min | >240 min | Same |
| 18 | Mitomycin-C, 0.5 mg/ml | >240 min | >240 min | >240 min | >240 min | >240 min | Same |
| 19 | Mitoxantrone HCl, 2 mg/ml | >240 min | / | >240 min | >240 min | >240 min | Same as ②and ③ |
| 20 | Pacilitaxel, 6 mg/ml | >240 min | >240 min | >240 min | >240 min | >240 min | Same |
| 20 | Thiotepa, 10 mg/ml | 25.3 min | 10.1 min | 44.9 min | 17.9 min | 13.6 min | Different |
| 22 | Vincristine Sulfate, 1 mg/ml | >240 min | >240 min | >240 min | >240 min | >240 min | Same |
| 23 | Arsenic Trioxide,1.0 mg/ml | / | / | / | / | >240 min | Different |
| 24 | Bendamustine HCl, 5 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 25 | Bleomycin Sulfate,15.0 mg/ml | / | / | / | / | >240 min | Different |
| 26 | Bortezomib,1 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 27 | Busulfan, 6 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 28 | Carfilzomib, 2 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 29 | Cetuximab (Erbitux), 2 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 30 | Chloroquine, 50mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 31 | Cladribine, 1.0 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 32 | Cyclosporin A,100mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 33 | Cytovene, 10 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 34 | Decitabine, 5 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 35 | Docetaxel, 10 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 36 | Epirubicin HCl, 2 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 37 | Fludarabine, 25 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 38 | Fulvestrant, 50.0 mg/ml | / | / | / | / | >240 min | Different |
| 39 | Mesna, 100 mg/ml | / | / | / | / | >240 min | Different |
| 40 | Oxaliplatin, 2 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
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| 41 | Paraplatin,10.0 mg/ml | / | / | / | / | >240 min | Different |
| 42 | Pemetrexed, 25.0 mg/ml | / | / | / | / | >240 min | Different |
| 43 | Pertuzumab,30.0 mg/ml | / | / | / | / | >240 min | Different |
| 44 | Raltitrexed, 0.5 mg/ml | / | / | / | / | >240 min | Different |
| 45 | Retrovir, 10 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 46 | Rituximab, 10.0 mg/ml | / | / | / | / | >240 min | Different |
| 47 | Temsirolimus, 25.0 mg/ml | / | / | / | / | >240 min | Different |
| 48 | Topotecan HCl,1.0 mg/ml | / | / | / | / | >240 min | Different |
| 49 | Trastuzumab,21.0 mg/ml | / | / | / | / | >240 min | Different |
| 50 | Triclosan,2.0 mg/ml | / | / | / | / | >240 min | Different |
| 51 | Trisenox,1.0 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 52 | Vidaza (Azacitidine),25 mg/ml | / | / | >240 min | >240 min | >240 min | Different |
| 53 | Vinblastine, 1.0 mg/ml | / | / | / | / | >240 min | Different |
| 54 | Vinorelbine,10.0 mg/ml | / | / | / | / | >240 min | Different |
| 55 | Zoledronic Acid, 0.8 mg/ml | / | / | / | / | >240 min | Different |
| NO. | Fentanyl, Gastric Acid and Xylazine | Minimum Breakthrough Detection Time | Result of comparison | |||
|---|---|---|---|---|---|---|
| Proposed device | Predicate device K231365 ① | Reference DeviceK243441② | Reference Device K244034③ | |||
| Light blue | Dark blue | |||||
| 1 | Fentanyl Citrate Injection,50mcg/ml | >240 min | >240 min | >240 min | >240 min | >240 min |
| 2 | Gastric Acid | >240 min | / | >240 min | >240 min | / |
| 3 | Xylazine HCl Injection (100 mg/ml) | / | / | / | / | >240 min |
| 4 | Fentanyl Citrate (50mcg/ml): Xylazine HCl (100mg/ml), 50:50 | >240 min | / | / | / | / |
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this different does not raise questions of safety and effectiveness.
8. Summary of Non-Clinical Testing
Biocompatibility
Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the proposed device is Surface and External Communicating Device and duration of contact is A-Limited (≤24h). The following tests for the proposed device were conducted to evaluate the biocompatibility of Nitrile Disposable Examination Gloves as per Guidance for Industry and FDA Staff‐Medical Glove Guidance Manual issued on January 22, 2008:
- ISO 10993-23: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- ISO 10993-11: Systemic Toxicity*
*Similar to the predicate, Acute Systemic Toxicity was performed in lieu of Cytotoxicity testing.
Performance Testing
Physical Performance testing of the proposed device was conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. Permeation testing was conducted to support the addition of the labeling claim. The proposed device was also tested according to ASTM D6978-05 (2023) Standard Practice for Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough
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times were determined for a wide range of chemotherapy drugs and fentanyl citrate, simulated gastric acid, and fentanyl citrate: xylazine HCL.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance to the relevant test methods cited below:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6978-05 Standard Practice for Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs
From the test result, we find that the product can meet the requirements as its intended use indicates.
| Test performed | Methodology | Acceptance Criteria | Result |
|---|---|---|---|
| Freedom From Holes | ASTM D6319-19 ASTM D5151-19 | Meet requirement inspection level G- 1, AQL 2.5 (ISO2859-1) | Pass |
| Dimension-Length | ASTM D6319-19 | Minimum 220mm for size XS-S Minimum 230mm for size M-XXL | Pass |
| Dimension-Width | ASTM D6319-19 | XS: 70±10mm S: 80±10mm M: 95±10mm L:110±10mm XL: 120±10mm XXL: 130±10mm | Pass |
| Dimension-Thickness | ASTM D6319-19 | Finger: 0.05mm (min) Palm: 0.05mm (min) | Pass |
| Physical properties | ASTM D6319-19 ASTM D412-16 | Tensile Strength (Before and After Aging 14 Mpa Min) Elongation (Before Aging 500% and after aging 400% Min) | Pass |
| Powder Residue | ASTM D6319-19 ASTM D6124-06 | Not more than 2 mg per glove | Pass |
| Skin Irritation | ISO10993-23:2021 | Under the conditions of the study, not a primary skin irritant | Pass |
| Skin Sensitization | ISO10993-10:2021 | Under the conditions of the study, not a contact sensitizer | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Under the conditions of the study, no signs of acute systemic toxicity were observed | Pass |
| Chemotherapy Drug | ASTM D6978-05 | Refer to the above table | Pass |
9. Summary of Clinical Testing:
Not applicable.
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10. Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.