(86 days)
Not Found
No
The device is a physical glove and the summary describes standard non-clinical testing for physical properties, chemical permeation, and biocompatibility, with no mention of AI/ML or data processing beyond standard test results.
No.
The device is described as a disposable glove intended to prevent contamination between patient and examiner, serving as a barrier, rather than providing any therapeutic effect to the patient.
No.
The device description and intended use clearly indicate that the device is a glove worn on the hand to prevent contamination, acting as a barrier. It is not designed to provide any diagnostic information or perform a diagnostic function.
No
The device described is a physical glove made of nitrile latex, not a software application. The summary details its material, physical properties, and testing against standards for physical performance and chemical permeation, with no mention of software components or functions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a glove worn on the examiner's hand to prevent contamination between patient and examiner. Its primary function is a barrier.
- Intended Use: The intended use is for medical purposes as a barrier, not for analyzing biological specimens.
- Testing: While the gloves are tested for permeation by substances like chemotherapy drugs and gastric acid, this testing is to assess the glove's barrier properties, not to diagnose or monitor a patient's condition based on a biological sample.
The device is a medical device, specifically a Class I patient examination glove, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The glove is 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 and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Product codes
LZA, LZC, ODO, OPJ
Device Description
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) 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, and single use only, and come in different sizes- XS, S, M, L, XL and XXL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
- Freedom From Holes: ASTM D6319-19, ASTM D5151-19. Result: Pass (Meet requirement inspection level G- 1, AQL 2.5 (ISO2859-1)).
- Dimension-Length: ASTM D6319-19. Result: Pass (Minimum 220mm for size XS-S, Minimum 230mm for size M-XXL).
- Dimension-Width: ASTM D6319-19. Result: Pass (XS: 70±10mm, S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: 120±10mm, XXL: 130±10mm).
- Dimension-Thickness: ASTM D6319-19. Result: Pass (Finger: 0.05mm (min), Palm: 0.05mm (min)).
- Physical properties: ASTM D6319-19, ASTM D412-16. Result: Pass (Tensile Strength (Min 14 Mpa), Elongation (Before Aging 500% and after aging 400%) Min).
- Powder Residue: ASTM D6319-19, ASTM D6124-06. Result: Pass (Not more than 2 mg per glove).
- Skin Irritation: ISO10993-23:2021. Result: Pass (Not a primary skin irritant).
- Skin Sensitization: ISO10993-10:2021. Result: Pass (Not a contact sensitizer).
- Acute Systemic Toxicity: ISO 10993-11:2017. Result: Pass (No acute systemic toxicity).
- Chemotherapy Drug, Fentanyl, and Gastric Acid: ASTM D6978-05. Result: Remark (Minimum Breakthrough Detection Time (minutes)).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 31, 2025
Basic Medical Technology Inc. John Zhao General Manager 5300 Concours Street Ontario, California 91764
Re: K243441
Trade/Device Name: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: November 6, 2024 Received: November 6, 2024
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.
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"
1
(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 OS 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 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-reportingcombination-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 Rue"). 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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
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
3
Indications for Use
Submission Number (if known)
K243441
Device Name
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)
Indications for Use (Describe)
The glove is 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 and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs. Light Blue glove: Chemotherapy Drugs Minimum Breakthrough Detection Time (minutes) Bendamustine HCl. 5 mg/ml >240 Bortezomib, 1 mg/ml >240 Busulfan, 6 mg/ml >240 Carboplatin, 10 mg/ml >240 Carmustine, 3.3 mg/ml 16.6 >240 Carfilzomib, 2 mg/ml Cetuximab (Erbitux) 2 mg/ml >240 Chloroquine, 50mg/ml >240. >240 Cisplatin, 1 mg/ml >240 Cladribine, 1.0 mg/ml >240 Cyclophosphamide, 20 mg/ml Cyclosporin A, 100mg/ml >240 Cytarabine HCl, 100 mg/ml >240 Cytovene, 10 mg/ml >240 >240 Dacarbazine, 10 mg/ml Daunorubicin HCI, 5 mg/ml >240 >240 Decitabine, 5 mg/ml Docetaxel, 10 mg/ml >240 Doxorubicin HCl, 2 mg/ml >240 Epirubicin HCl, 2 mg/ml >240 Etoposide, 20 mg/ml >240 Fludarabine, 25 mg/ml >240 Fluorouracil, 50 mg/ml >240 Gemcitabine HCl., 38 mg/ml >240 Idarubicin HCl,, 1 mg/ml >240 Ifosfamide, 50 mg/ml >240 Irinotecan. 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 HCl. 2 mg/ml >240 Oxaliplatin, 2 mg/ml >240 Paclitaxel, 6 mg/ml >240
4
| Retrovir, 10 mg/ml | >240 |
|---|---|
| ThioTEPA, 10 mg/ml | 44.9 |
| Trisenox, 1 mg/ml | >240 |
| Vidaza (Azacitidine),25 mg/ml | >240 |
| Vincristine Sulfate, 1 mg/ml | >240 |
| Fentanyl Citrate and Gastric Acid | Minimum Breakthrough Detection Time, minutes |
| Fentanyl Citrate Injection, 100mcg/2ml | >240 |
| Simulated Gastric Acid | >240 |
| *Please note that the following drugs have extremely low permeation times: | |
| Carmustine: 16.6 minutes, Thio Tepa: 44.9 minutes | |
| Warning: Do not use with Carmustine and Thio Tepa. | |
| Dark Blue glove: | |
| Chemotherapy Drugs | Minimum Breakthrough Detection Time (minutes) |
| Bendamustine HCI, 5 mg/ml | >240 |
| Bortezomib, 1 mg/ml | >240 |
| Busulfan, 6 mg/ml | >240 |
| Carboplatin, 10 mg/ml | >240 |
| Carmustine, 3.3 mg/ml | 21.5 |
| Carfilzomib, 2 mg/ml | >240 |
| Cetuximab (Erbitux) 2 mg/ml | >240 |
| Chloroquine, 50mg/ml | >240. |
| Cisplatin, 1 mg/ml | >240 |
| Cladribine, 1.0 mg/ml | >240 |
| Cyclophosphamide, 20 mg/ml | >240 |
| Cyclosporin A, 100mg/ml | >240 |
| Cytarabine HCI, 100 mg/ml | >240 |
| Cytovene, 10 mg/ml | >240 |
| Dacarbazine, 10 mg/ml | >240 |
| Daunorubicin HCI, 5 mg/ml | >240 |
| Decitabine, 5 mg/ml | >240 |
| Docetaxel, 10 mg/ml | >240 |
| Doxorubicin HCl, 2 mg/ml | >240 |
| Epirubicin HCl, 2 mg/ml | >240 |
| Etoposide, 20 mg/ml | >240 |
| Fludarabine, 25 mg/ml | >240 |
| Fluorouracil, 50 mg/ml | >240 |
| Gemcitabine HCl, 38 mg/ml | >240 |
| Idarubicin HCl, 1 mg/ml | >240 |
| Ifosfamide, 50 mg/ml | >240 |
| Irinotecan, 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 HCl, 2 mg/ml | >240 |
| Oxaliplatin, 2 mg/ml | >240 |
| Paclitaxel, 6 mg/ml | >240 |
| Retrovir, 10 mg/ml | >240 |
| ThioTEPA, 10 mg/ml | 17.9 |
5
| Trisenox, 1 mg/ml | >240 |
|---|---|
| Vidaza (Azacitidine),25 mg/ml | >240 |
| Vincristine Sulfate, 1 mg/ml | >240 |
| Fentanyl Citrate and Gastric Acid | Minimum Breakthrough Detection Time, minutes |
| Fentanyl Citrate Injection, 100mcg/2ml | >240 |
| Simulated Gastric Acid | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 21.5 minutes, Thio Tepa: 17.9 minutes
Warning: Do not use with Carmustine and Thio Tepa.
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)
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6
5300 Concours Ontario, CA 91764
510(K) Summary K243441
1. Submission Information
Date Prepared: January 31, 2025 Submission Format: Traditional 510(k) 510(K)#: K243441
2. Submitter Information
Applicant Name: Basic Medical Technology Inc. Address: 5300 Concours Street, Ontario, CA 91764
Contact Person: John Zhao Tel : (909) 980-1678 Email: johnzhao@basicmedical.com
3. Device Information
Trade Name: Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)
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
Lingshi Hongruida Health Protection Technology Co., Ltd.
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs (K240051)
Product code : LZA, LZC, QDO, OPJ.
5. Device Description:
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) 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, and single use only, and come in different sizes- XS, S, M, L, XL and XXL.
7
5300 Concours Ontario, CA 91764
The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs, Fentanyl Citrate and Gastric Acid.
6. Indications for Use:
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 Chemotherapy drugs, Fentanyl and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Light Blue glove:
| NO. | Chemotherapy drug | Minimum Breakthrough Detection Time, minutes |
|---|---|---|
| 1 | Bendamustine HCl, 5 mg/ml | >240 |
| 2 | Bortezomib, 1 mg/ml | >240 |
| 3 | Busulfan, 6 mg/ml | >240 |
| 4 | Carboplatin, 10 mg/ml | >240 |
| 5 | Carmustine, 3.3 mg/ml | 16.6 |
| 6 | Carfilzomib, 2 mg/ml | >240 |
| 7 | Cetuximab (Erbitux), 2 mg/ml | >240 |
| 8 | Chloroquine, 50mg/ml | >240 |
| 9 | Cisplatin, 1 mg/ml | >240 |
| 10 | Cladribine, 1.0 mg/ml | >240 |
| 11 | Cyclophosphamide, 20 mg/ml | >240 |
| 12 | Cyclosporin A,100mg/ml | >240 |
| 13 | Cytarabine HCl, 100 mg/ml | >240 |
| 14 | Cytovene, 10 mg/ml | >240 |
| 15 | Dacarbazine, 10 mg/ml | >240 |
| 16 | Daunorubicin HCl, 5 mg/ml | >240 |
| 17 | Decitabine, 5 mg/ml | >240 |
| 18 | Docetaxel, 10 mg/ml | >240 |
| 19 | Doxorubicin HCl, 2 mg/ml | >240 |
| 20 | Epirubicin HCl, 2 mg/ml | >240 |
| 21 | Etoposide, 20 mg/ml | >240 |
| 22 | Fludarabine, 25 mg/ml | >240 |
| 23 | Fluorouracil, 50 mg/ml | >240 |
| 24 | Gemcitabine HCl, 38 mg/ml | >240 |
| 25 | Idarubicin HCl, 1 mg/ml | >240 |
| 26 | Ifosfamide, 50 mg/ml | >240 |
| 27 | Irinotecan HCl, 20 mg/ml | >240 |
| 28 | Mechlorethamine HCl, 1 mg/ml | >240 |
| 29 | Melphalan HCl, 5 mg/ml | >240 |
| 30 | Methotrexate, 25 mg/ml | >240 |
| 31 | Mitomycin-C, 0.5 mg/ml | >240 |
| 32 | Mitoxantrone HCl, 2 mg/ml | >240 |
8
5300 Concours Ontario, CA 91764
| 33 | Oxaliplatin, 2 mg/ml | >240 |
|---|---|---|
| 34 | Paclitaxel, 6 mg/ml | >240 |
| 35 | Retrovir, 10 mg/ml | >240 |
| 36 | ThioTEPA, 10 mg/ml | 44.9 |
| 37 | Trisenox, 1 mg/ml | >240 |
| 38 | Vidaza (Azacitidine),25 mg/ml | >240 |
| 39 | Vincristine Sulfate,1 mg/ml | >240 |
| NO. | Fentanyl Citrate and Gastric Acid | Minimum Breakthrough Detection Time, minutes |
| 1 | Fentanyl Citrate Injection, 100mcg/2ml | >240 |
| 2 | Simulated Gastric Acid | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 16.6 minutes, Thio Tepa: 44.9 minutes
Warning: Do not use with Carmustine and Thio Tepa.
Dark Blue glove:
| NO. | Chemotherapy drug | Minimum Breakthrough Detection Time, minutes |
|---|---|---|
| 1 | Bendamustine HCl, 5 mg/ml | >240 |
| 2 | Bortezomib, 1 mg/ml | >240 |
| 3 | Busulfan, 6 mg/ml | >240 |
| 4 | Carboplatin, 10 mg/ml | >240 |
| 5 | Carmustine, 3.3 mg/ml | 21.5 |
| 6 | Carfilzomib, 2 mg/ml | >240 |
| 7 | Cetuximab (Erbitux), 2 mg/ml | >240 |
| 8 | Chloroquine, 50mg/ml | >240 |
| 9 | Cisplatin, 1 mg/ml | >240 |
| 10 | Cladribine, 1.0 mg/ml | >240 |
| 11 | Cyclophosphamide, 20 mg/ml | >240 |
| 12 | Cyclosporin A,100mg/ml | >240 |
| 13 | Cytarabine HCl, 100 mg/ml | >240 |
| 14 | Cytovene, 10 mg/ml | >240 |
| 15 | Dacarbazine, 10 mg/ml | >240 |
| 16 | Daunorubicin HCl, 5 mg/ml | >240 |
| 17 | Decitabine, 5 mg/ml | >240 |
| 18 | Docetaxel, 10 mg/ml | >240 |
| 19 | Doxorubicin HCl, 2 mg/ml | >240 |
| 20 | Epirubicin HCl, 2 mg/ml | >240 |
| 21 | Etoposide, 20 mg/ml | >240 |
| 22 | Fludarabine, 25 mg/ml | >240 |
| 23 | Fluorouracil, 50 mg/ml | >240 |
| 24 | Gemcitabine HCl, 38 mg/ml | >240 |
| 25 | Idarubicin HCl, 1 mg/ml | >240 |
| 26 | Ifosfamide, 50 mg/ml | >240 |
| 27 | Irinotecan HCl, 20 mg/ml | >240 |
| 28 | Mechlorethamine HCL, 1 mg/ml | >240 |
| 29 | Melphalan HCl, 5 mg/ml | >240 |
9
5300 Concours Ontario, CA 91764
| 30 | Methotrexate, 25 mg/ml | >240 |
|---|---|---|
| 31 | Mitomycin-C, 0.5 mg/ml | >240 |
| 32 | Mitoxantrone HCl, 2 mg/ml | >240 |
| 33 | Oxaliplatin, 2 mg/ml | >240 |
| 34 | Paclitaxel, 6 mg/ml | >240 |
| 35 | Retrovir, 10 mg/ml | >240 |
| 36 | ThioTEPA, 10 mg/ml | 17.9 |
| 37 | Trisenox, 1 mg/ml | >240 |
| 38 | Vidaza (Azacitidine),25 mg/ml | >240 |
| 39 | Vincristine Sulfate,1 mg/ml | >240 |
| NO. | Fentanyl Citrate and Gastric Acid | Minimum Breakthrough Detection Time, minutes |
| 1 | Fentanyl Citrate Injection, 100mcg/2ml | >240 |
| 2 | Simulated Gastric Acid | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 21.5 minutes, Thio Tepa:17.9 minutes
Warning: Do not use with Carmustine and Thio Tepa.
7. Comparison of Subject Device and Predicate Device:
General Comparison Table:
| | Proposed Device | Predicate Device
K240051 | Result |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Name | Nitrile Powder-Free Exam Gloves
Tested for Use with Chemotherapy
Drugs, Opioid Fentanyl Citrate,
Simulated Gastric Acid (Light blue, Dark
blue) | Powder Free Nitrile Examination
Gloves (Blue), Tested for Use with
Chemotherapy Drugs. Fentanyl Citrate,
and select other drugs | |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ | Same |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Device
Classification | Class I | Class I | Same |
| Indications for
use | 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
Chemotherapy drugs, Fentanyl and
Gastric acid in accordance with ASTM
D6978-05 standards Practice for
assessment of Medical Glove to
Permeation by chemotherapy drugs | 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 have been tested for use with
chemotherapy drugs, Fentanyl Citrate,
and select other drugs using ASTM
D6978-05(2019) | Same |
| Powder free | Yes | Yes | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Light Blue, Dark blue | Blue | Different |
10
5300 Concours Ontario, CA 91764
| Size | XS, S, M, L, XL, XXL | XS, S, M, L, XL, XXL | Same |
|---|---|---|---|
| Sterile | Non-Sterile | Non-Sterile | Same |
| Single Use | Single use | Single use | Same |
| Design feature | Ambidextrous | Ambidextrous | Same |
| Chemo Drugs | |||
| Claim | See below comparison table | See below comparison table |
Analysis: * The finished subject device has been tested with performance and Biocompatibility, all the test results meet the requirements, so the difference of color does not raise questions of safety and effectiveness.
| Technological Characteristic Comparison Table: | |||||
|---|---|---|---|---|---|
| ------------------------------------------------ | -- | -- | -- | -- | -- |
| Characteristics | | Proposed device | Predicate device
K240051 | 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 | Same |
| | 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 | |
| | Thickness | Palm: Min 0.05 mm
Finger: Min 0.05 mm | Palm: Min 0.05 mm
Finger: Min 0.05 mm | |
| | | | | |
| Physical properties
ASTM D6319-19
ASTM D412-16 | Before aging | | | |
| | Tensile strength | Min 14MPa | Min 14MPa | Same |
| | Ultimate elongation | Min 500% | Min 500% | |
| | After aging | | | |
| | Tensile strength | Min 14MPa | Min 14MPa | |
| | Ultimate elongation | Min 400% | Min 400% | |
| Freedom from holes
ASTM D6319-19; ASTM D5151-19 | | G-I, AQL2.5 | G-I, AQL2.5 | Same |
| Residual Powder
ASTM D6319-19; ASTM D6124-06 | | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |
| Biocompatibility | Irritation
ISO 10993-23 | Under the conditions of
the study, not an
irritant | Under the conditions of the
study, not an irritant | Same |
| | Sensitization
ISO 10993-10 | Under the conditions of
the study, not a
sensitizer | Under the conditions of the
study, not a sensitizer | Same |
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5300 Concours Ontario, CA 91764
| Acute Systemic
Toxicity Test
| ISO 10993 - 11 | Under the conditions of this study, there was no evidence of acute systemic toxicity. | Under the conditions of this study, there was no evidence of acute systemic toxicity. | Same |
|---|---|---|---|
| --------------------------------------------------- | --------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------- | ------ |
Chemotherapy Drugs Comparison Claim:
| Minimum Breakthrough Detection Time, minutes | |||||
|---|---|---|---|---|---|
| NO. | Chemotherapy Drugs | Proposed device | Predicate device | Result of | |
| comparison | |||||
| Light Blue | Dark Blue | K240051 | |||
| 1 | Bendamustine HCl, 5 mg/ml | >240 | >240 | Different | |
| 2 | Bortezomib, 1 mg/ml | >240 | >240 | >240 | Same |
| 3 | Busulfan, 6 mg/ml | >240 | >240 | >240 | Same |
| 4 | Carboplatin, 10 mg/ml | >240 | >240 | >240 | Same |
| 5 | Carmustine, 3.3 mg/ml | 16.6 | 21.5 | 29.1 | Different |
| 6 | Carfilzomib, 2 mg/ml | >240 | >240 | Different | |
| 7 | Cetuximab (Erbitux), 2 mg/ml | >240 | >240 | Different | |
| 8 | Chloroquine, 50mg/ml | >240 | >240 | >240 | Same |
| 9 | Cisplatin, 1 mg/ml | >240 | >240 | >240 | Same |
| 10 | Cladribine, 1.0 mg/ml | >240 | >240 | Different | |
| 11 | Cyclophosphamide, 20 mg/ml | >240 | >240 | >240 | Same |
| 12 | Cyclosporin A,100mg/ml | >240 | >240 | >240 | Same |
| 13 | Cytarabine HCl, 100 mg/ml | >240 | >240 | >240 | Same |
| 14 | Cytovene, 10 mg/ml | >240 | >240 | Different | |
| 15 | Dacarbazine, 10 mg/ml | >240 | >240 | >240 | Same |
| 16 | Daunorubicin HCl, 5 mg/ml | >240 | >240 | >240 | Same |
| 17 | Decitabine, 5 mg/ml | >240 | >240 | Different | |
| 18 | Docetaxel, 10 mg/ml | >240 | >240 | >240 | Same |
| 19 | Doxorubicin HCl, 2 mg/ml | >240 | >240 | >240 | Same |
| 20 | Epirubicin HCl, 2 mg/ml | >240 | >240 | >240 | Same |
| 21 | Etoposide, 20 mg/ml | >240 | >240 | >240 | Same |
| 22 | Fludarabine, 25 mg/ml | >240 | >240 | >240 | Same |
| 23 | Fluorouracil, 50 mg/ml | >240 | >240 | >240 | Same |
| 24 | Gemcitabine HCl, 38 mg/ml | >240 | >240 | >240 | Same |
| 25 | Idarubicin HCl, 1 mg/ml | >240 | >240 | >240 | Same |
| 26 | Ifosfamide, 50 mg/ml | >240 | >240 | >240 | Same |
| 27 | Irinotecan HCl, 20 mg/ml | >240 | >240 | >240 | Same |
| 28 | Mechlorethamine HCL, 1 mg/ml | >240 | >240 | >240 | Same |
| 29 | Melphalan HCl, 5 mg/ml | >240 | >240 | >240 | Same |
| 30 | Methotrexate, 25 mg/ml | >240 | >240 | >240 | Same |
| 31 | Mitomycin-C, 0.5 mg/ml | >240 | >240 | >240 | Same |
| 32 | Mitoxantrone HCl, 2 mg/ml | >240 | >240 | >240 | Same |
| 33 | Oxaliplatin, 2 mg/ml | >240 | >240 | >240 | Same |
| 34 | Paclitaxel, 6 mg/ml | >240 | >240 | >240 | Same |
| 35 | Retrovir. 10 mg/ml | >240 | >240 | >240 | Same |
12
5300 Concours Ontario, CA 91764
| 36 | ThioTEPA, 10 mg/ml | 44.9 | 17.9 | 78.3 | Different |
|---|---|---|---|---|---|
| 37 | Trisenox, 1 mg/ml | >240 | >240 | >240 | Same |
| 38 | Vidaza (Azacitidine),25 mg/ml | >240 | >240 | Different | |
| 39 | Vincristine Sulfate,1 mg/ml | >240 | >240 | >240 | Same |
| NO. | Fentanyl Citrate and Gastric Acid | Minimum Breakthrough Detection Time, minutes | Result of | ||
| comparison | |||||
| Proposed device | Predicate device | ||||
| K240051 | |||||
| 1 | Fentanyl Citrate | ||||
| Injection,100mcg/2ml | >240 | >240 | >240 | Same |
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this difference does not raise questions of safety and effectiveness.
8. Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| 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 (Min 14 Mpa) | ||
| 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 | Not a primary skin irritant | Pass |
| Skin Sensitization | ISO10993-10:2021 | Not a contact sensitizer | Pass |
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5300 Concours Ontario, CA 91764
| Acute Systemic Toxicity | ISO 10993-11:2017 | No acute systemic toxicity | Pass |
|---|---|---|---|
| Chemotherapy Drug, | |||
| Fentanyl, and Gastric Acid | ASTM D6978-05 | Minimum Breakthrough Detection Time (minutes) | Remark |
- · ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- . ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- · ASTM D6124-06 (2017), Standard Test Method for Residual Powder on Medical Gloves
- ASTM D412-16 (2021), Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers— Tension
- · ASTM D6978-05(2023), Assessment of Reissuance of Medical Gloves to Permeation by Chemotherapy Drugs.
- · ISO 10993-10: 2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization.
- · ISO10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation.
- · ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
9. Summary of Clinical Testing:
Not applicable.
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, K240051.