(116 days)
Not Found
No
The 510(k) summary describes standard examination gloves and their physical and chemical properties, with no mention of AI or ML.
No.
The device is described as an examination glove intended to prevent contamination between patient and examiner, primarily for protection, not for treating a disease or condition.
No
Explanation: The device, Powder Free Nitrile Examination Gloves, is described as a disposable device worn on the examiner's hand to prevent contamination. Its function is to provide a barrier, not to diagnose any medical condition or disease.
No
The device is described as physical examination gloves, which are hardware, not software. The summary details physical properties and performance studies related to the material and construction of the gloves.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces that these are "Patient Examination Gloves and Specialty Chemotherapy Gloves," focusing on their physical properties and resistance to chemicals.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The testing described relates to the physical properties of the glove and its barrier function.
Therefore, this device falls under the category of a medical device, specifically a Class I examination glove, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs 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 using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes—Extra Small, Small, Medium, Large, Extra Large and XXL.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
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
examiner / medical purposes
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 complies with the following standards:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systematic toxicity
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves to Permeation by Chemotherapy Drugs.
Key Results:
- Length: All size >= 230mm
- Palm Width: XS: 77-78mm, S: 86-88 mm, M: 96-98mm, L: 108-110 mm, XL: 116-117 mm, XXL: 126-127 mm
- Thickness Finger: >= 0.05mm, Palm: >= 0.05mm
- Tensile Strength, Before Aging: >= 14 MPa
- Tensile Strength, After Accelerated Aging: >= 14 MPa
- Ultimate Elongation, Before Aging: >= 500%
- Ultimate Elongation, After Accelerated Aging: >= 400%
- Freedom from holes: Meet and above AQL2.5 requirements
- Powder-Content: 240 minutes for most others).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for minimum breakthrough times (BDT) for chemotherapy drugs and other performance metrics.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 18, 2022
Luliang Hongruida Health Protection Technology Co., Ltd. % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue, Chino, California 91710
Re: K213440
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: December 23, 2021 Received: January 10, 2022
Dear Kathy Liu:
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 (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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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).
Sincerely.
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213440
Device Name
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs 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 using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.
The following chemicals have been tested with these gloves:
| For Blue gloves: | |
|---|---|
| Chemotherapy Drug | Minimum BDT (Minutes) |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine 3.3 mg/ml (3,300 ppm) | 25.5 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel HCL, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin/Carboplatin, 10mg/ml (10,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 66.8 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
3
Vincristine Sulfate, 1mg/ml (1,000ppm) >240 * Please note that the following drugs have extremely low permeation times: Carmustine: 25.5 minutes, Thiotepa: 66.8 minutes
| For Purple-Blue gloves: | |
|---|---|
| Chemotherapy Drug | Minimum BDT (Minutes) |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine 3.3 mg/ml (3,300 ppm) | 21.2 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel HCL, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin/Carboplatin, 10mg/ml (10,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 36.3 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| * Please note that the following drugs have extremely low permeation times: | |
| Carmustine: 21.2 minutes, Thiotepa: 36.3 minutes |
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
∑ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China
510(K) SUMMARY
The assigned 510(K) numbers: K213440 Date Prepared: December 23, 2021
1. Owner's Identification:
Mr. Zhang Guocai Luliang Hongruida Health Protection Technology Co., Ltd. Zhaokua Area, Luliang Industrial Zone, Quiing City, Yunnan Province, 655606 China
Tel: 86-311-66766067 Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel: 909-590-1611 Email: kathyliu@hongrayusa.com or fdareg@126.com
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs Common Name: Examination Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA LZC Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Better Care Plastic Technology Co., Ltd Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) (K182600)
4. Device Description:
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes—Extra Small, Small, Medium, Large, Extra Large and XXL.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
6
Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China
510(K) SUMMARY
5. Indications for Use:
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs 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 using ASTM D6978-05(2019) and will be labeled with a statement of compliance and a summary of the testing results. Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves: Blue øloves
| Blue gloves | |
|---|---|
| Chemotherapy Drug | Minimum BDT (Minutes) |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine 3.3 mg/ml (3,300 ppm) | 25.5 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel HCL, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin/Carboplatin, 10mg/ml (10,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 66.8 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
7
Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China
510(K) SUMMARY
| Trisenox, 1mg/ml (1,000ppm) | >240 |
|---|---|
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
- Please note that the following drugs have extremely low permeation times: Carmustine: 25.5 minutes, Thiotepa: 66.8 minutes
Purple-Blue gloves
| Chemotherapy Drug | Minimum BDT (Minutes) |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine 3.3 mg/ml (3,300 ppm) | 21.2 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel HCL, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin/Carboplatin, 10mg/ml (10,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 36.3 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib) , 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
- Please note that the following drugs have extremely low permeation times:
Carmustine: 21.2 minutes, Thiotepa: 36.3 minutes
8
Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China
510(K) SUMMARY
6. Comnarison of Subiect Device and Predicate Device:
The proposed device will be known as Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs.
The following tables are summaries of the technological characteristics, biocompatibility and testing for use with chemotherapy drugs of the proposed and predicate devices.
| | Proposed Device
K213440 | Predicate Device
K182600 | Remark |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Trade Name | Powder Free Nitrile
Examination Gloves
(Blue, Purple-Blue),
Tested for Use with
Chemotherapy Drugs | Powder Free Nitrile
Examination Gloves,
Tested for Use with
Chemotherapy Drugs
(Blue) | Similar |
| Product Code | LZA, LZC | LZA, LZC | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | Powder Free Nitrile
Examination Gloves (Blue,
Purple-Blue), Tested for Use
with Chemotherapy Drugs is
a disposable device intended
for medical purposes that is
worn on the examiner's hand
to prevent contamination
between patient and examiner. | Powder Free Nitrile
Examination Gloves, Tested for
Use with Chemotherapy Drugs
(Blue) is a disposable device
intended for medical purposes
that is worn on the examiner's
hand to prevent contamination
between patient and examiner. | Same |
| Powder or Powder
Free | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Blue, Purple-Blue | Blue | Similar |
| Labeling
Information | Single-use, powder free
glove size, quantity,
Nitrile Examination
Gloves, Non Sterile | Single-use, powder free glove
size, quantity, Nitrile
Examination Gloves, Non
Sterile | Same |
| Chemotherapy Drug
Permeation Claim | See below comparison
table | See below comparison table | Same |
General Comparison Table:
Dimensions and Performance Comparison Table:
| Technological | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| --------------- | ----------------- | ------------------ | -------- |
9
| Characteristics | K213440 | K182600 | |
|---|---|---|---|
| Length | Minimum 230mm | Minimum 230mm | Same |
| Palm Width (size) (mm) | |||
| XS | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | Same |
| XXL | 130±10 | 130±10 | Same |
| Thickness(mm) | |||
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, | |||
| Before Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, | |||
| Before Aging | 500%, min | 500%, min | Same |
| Tensile Strength, After | |||
| Accelerated Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, | |||
| After Accelerated | |||
| Aging | 400%, min | 400%, min | Same |
| Freedom from holes | In accordance with | ||
| ASTM D 5151-19, | |||
| following ASTM D6319- 19, | |||
| G-I, AQL 2.5 | In accordance with | ||
| ASTM D 5151-19, | |||
| following ASTM D6319- 19, | |||
| G-I, AQL 2.5 | Same | ||
| Powder-Content | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |
| 10993-10:2010 Skin | |||
| Irritation Study | Under the conditions of the | ||
| study, not an irritant | Under the conditions of the | ||
| study, not an irritant | Same | ||
| 10993-10:2010 | |||
| Maximization | |||
| Sensitization Study | Under the conditions of the | ||
| study, not a sensitizer | Under the conditions of the | ||
| study, not a sensitizer | Same | ||
| 10993-5:2009 | |||
| Cytotoxicity Test | Under the conditions of this | ||
| study, the test article extract | |||
| showed potential toxicity | Under the conditions of | ||
| this study, no cytotoxic | |||
| potential | Same | ||
| ISO 10993 Part 11 | |||
| Systemic toxicity | Under the conditions of this | ||
| study, there was no evidence of | |||
| systemic toxicity. | / | Different |
10
Zhaokua Area, Luliang Industrial Zone, Qujing City,
Yunnan Province, 655606 China
510(K) SUMMARY
| Chemotherapy Permeation Comparison: | ||||
|---|---|---|---|---|
| Tested Chemotherapy Drug and | Minimum BDT (Minutes) | |||
| Concentration | Proposed Device | |||
| K213440 | Predicate Device | |||
| K182600 | Remark | |||
| Blue | Purple-Blue | |||
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | >240 | >240 | Same |
| Busulfan 6mg/ml (6,000 ppm) | >240 | >240 | >240 | Same |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | >240 | >240 | Same |
| Carmustine 3.3 mg/ml (3,300 ppm) | 7.0 | 25.5 | 21.2 | Similar |
| Chloroquine 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 | >240 | >240 | Same |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | >240 | >240 | Same |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | Same |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | >240 | >240 | Same |
| Docetaxel HCL, 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | Same |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | >240 | Same |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 | >240 | >240 | Same |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 | >240 | >240 | Same |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | >240 | >240 | Same |
| Irinotecan, 20mg/ml (20,000ppm) | >240 | >240 | >240 | Same |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same |
| Melphalan, 5mg/ml (5,000ppm) | >240 | >240 | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 | Same |
| Mitomycin, 0.5mg/ml (500ppm) | >240 | >240 | >240 | Same |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | >240 | >240 | Same |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 | >240 | >240 | Same |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 | Same |
| Paraplatin/Carboplatin, 10mg/ml (10,000ppm) | >240 | >240 | >240 | Same |
| Retrovir, 10mg/ml (10,000ppm) | >240 | >240 | >240 | Same |
| Rituximab, 10mg/ml (10,000ppm) | >240 | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 23.0 | 66.8 | 36.3 | Similar |
| Topotecan, 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same |
| Trisenox, 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same |
| Velcade (Bortezomib) , 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | >240 | >240 | Same |
11
Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China
510(K) SUMMARY
7. 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 complies with the following standards:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests For ● Irritation And Skin Sensitization.
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for . systemic toxicity
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on . Medical Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical ● Application.
- ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves ● to Permeation by Chemotherapy Drugs.
| Test method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Length | Minimum 230mm | All size ≥230 |
| ASTM D6319- 19 | Palm Width | XS: 70±10mm | 77-78mm |
| S: 80±10mm | 86-88 mm | ||
| M:95±10mm | 96 -98mm | ||
| L:110±10mm | 108-110 mm | ||
| XL: 120±10mm | 116-117 mm | ||
| XXL: 130±10mm | 126-127 mm | ||
| ASTM D6319- 19 | Thickness | Finger: 0.05mm (min) | |
| Palm: 0.05mm (min) | ≥0.05mm | ||
| ≥0.05mm | |||
| ASTM D6319-19 | |||
| ASTN D412-16 | Tensile Strength, Before | ||
| Aging | 14MPa, min | ≥14 MPa | |
| ASTM D6319-19 | |||
| ASTN D412-16 | Tensile Strength, After | ||
| Accelerated Aging | 14MPa, min | ≥14 MPa |
12
Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China
| 510(K) SUMMARY | |||
|---|---|---|---|
| ASTM D6319-19 | |||
| ASTN D412-16 | Ultimate Elongation, | ||
| Before Aging | 500%, min | ≥500% | |
| ASTM D6319-19 | |||
| ASTN D412-16 | Ultimate Elongation, | ||
| After Accelerated Aging | 400%, min | ≥400% | |
| ASTM D 5151-19 | |||
| ASTM D6319- 19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5 |
| requirements | |||
| ASTM D 6124-06(2017) | |||
| ASTM D6319- 19 | Powder-Content | ≤2 mg per glove | ≤2 mg, meet requirements |
| ISO 10993-10:2010 | Skin Irritation Study | Under the conditions of | |
| the study, not an irritant | Under the conditions of | ||
| the study, not an irritant | |||
| ISO 10993-10:2010 | Maximization | ||
| Sensitization Study | Under the conditions of | ||
| the study, not a sensitizer | Under the conditions of | ||
| the study, not a sensitizer | |||
| ISO 10993-5:2009 | Cytotoxicity Test | Under the conditions of | |
| this study, the test article | |||
| extract showed potential | |||
| toxicity | Under the conditions of this | ||
| study, the test article extract | |||
| showed potential toxicity | |||
| ISO 10993-11:2017 | Systemic toxicity | Under the conditions of | |
| this study, there was no | |||
| evidence of systemic | |||
| toxicity. | Under the conditions of this | ||
| study, there was no evidence | |||
| of systemic toxicity. | |||
| ASTM D6978-05 (2019) | Tested for Use with | ||
| Chemotherapy Drugs | / | Details refer to the above 5.0 | |
| result |
510/K) SUMMARV
8. Clinical Performance Data
N/A
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.