(30 days)
Not Found
No
The device description and performance studies focus on the physical properties and chemical resistance of examination gloves, with no mention of AI or ML technologies.
No
Explanation: The device is described as a disposable glove intended to prevent contamination between patient and examiner, and is tested for resistance to chemotherapy drugs and fentanyl citrate. Its primary function is protection and barrier, not therapeutic treatment or diagnosis of a disease.
No
The device is a medical glove intended to prevent contamination between patients and examiners, and it's tested for resistance to chemotherapy drugs and fentanyl citrate. Its purpose is protective, not diagnostic.
No
The device is a physical glove, not software. The description details material, physical properties, and testing related to a tangible product.
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, tissue) to provide information about a person's health. They are used outside the body.
- Device Description and Intended Use: The description clearly states the device is a glove worn on the examiner's hand to prevent contamination between patient and examiner. It's a barrier device used on the body (the examiner's hand) during patient interaction.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The testing performed (ASTM D6319, ASTM D6978, ISO 10993) relates to the physical properties of the glove and its resistance to chemicals, not the analysis of patient samples.
Therefore, based on the provided information, this device is a medical glove, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, gloves were tested for use with Chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, ODO, OPJ
Device Description
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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 and fentanyl citrate 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
Dermal / Hand
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 performed to verify that the subject device will meet the acceptance criteria of the performance test shown below:
- ASTM D6319-19: Physical Dimensions (Length, Palm Width, Thickness) - Pass
- ASTM D6319-19, ASTM D412-16 (2021): Physical Properties (Tensile Strength, Elongation) - Pass
- ASTM D6319-19, ASTM D5151-19: Freedom from holes (G-I, AQL 2.5) - Pass
- ASTM D6319-19, ASTM D6124-06 (2017): Powder Residue (Max 2mg/glove) - Pass
- ASTM D6978-05 (2019): Chemotherapy Drugs, Opioid Drug Permeation - Pass (refer to tables for specific drug permeation times)
- ISO 10993-10:2010: Irritation and Skin Sensitization - Is non-sensitization and Non-irritation
- ISO 10993-5:2009: Cytotoxicity Test - Under the conditions of this study, the test article extract showed potential toxicity
- ISO 10993-11:2017: Acute systemic toxicity study - Under the conditions of this study, there was no evidence of acute systemic toxicity.
No clinical testing was submitted for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 9, 2024
Luliang Hongruida Health Protection Technology Co., Ltd. Guocai Zhang General Manager Zhaokua Area, Luliang Industrial Zone, Qujing, Yunnan 655606 China
Re: K240072
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate 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: January 10, 2024 Received: January 10, 2024
Dear Guocai Zhang:
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 (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.
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).
Sincerely.
llan G
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
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
510(k) Number (if known) K240072
Device Name
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
The glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, gloves were tested for use with Chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978.
| 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 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| Fentanyl Citrate | Minimum BDT (Minutes) |
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
4
- Please note that the following drugs have extremely low permeation times: Carmustine: 25.5 minutes, Thiotepa: 66.8 minutes
Warning: Do not use with Carmustine and Thiotepa.
| 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 |
| Fentanyl Citrate | Minimum BDT (Minutes) |
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
| * Please note that the following drugs have extremely low permeation times: |
Carmustine: 21.2 minutes, Thiotepa: 36.3 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)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
5
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6
Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.
The assigned 510(K) numbers: K240072 Date Prepared: February 06, 2024
1. Owner's Identification:
Mr. Zhang Guocai Luliang Hongruida Health Protection Technology Co., Ltd. Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China Tel: 86-311-66179668
Contact: Mr. Zhang Guocai Luliang Hongruida Health Protection Technology Co., Ltd. Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China Tel: 909-590-1611 Email: fdareg(@hongray.com.cn or janicema(@)hongrayusa.com
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Examination Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA LZC QDO OPJ Classification Panel: General Hospital and Personal use Device Class: Class I
3. Predicate Device Information:
Luliang Hongruida Health Protection Technology Co., Ltd. Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs (K213440) Device Class: Class I Product Code: LZA LZC
4. Device Description:
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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 and fentanyl citrate as per ASTM D6978-05(2019).
5. Device Modification
The proposed modification to the predicate device is to add the claim that the subject device was tested for use with fentanyl citrate besides the claim of use with Chemotherapy drugs. The proposed device (exactly same as predicate device) was tested for use with fentanyl citrate as per ASTM D6978. There are no differences with these two gloves in materials, manufacturing process and bench performance.
7
Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China
6. Indications for Use:
The glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, gloves were tested for use with Chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978.
| 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 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| Fentanyl Citrate | Minimum BDT (Minutes) |
|---|---|
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
8
Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China
- Please note that the following drugs have extremely low permeation times: Carmustine: 25.5 minutes, Thiotepa: 66.8 minutes Warning: Do not use with Carmustine and Thiotepa. Purple-Blue gloves
Minimum BDT (Minutes) Chemotherapy Drug 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 >240 Cisplatin 1mg/ml (1,000 ppm) 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 >240 Irinotecan, 20mg/ml (20,000ppm) Mechlorethamine HCI, 1mg/ml (1,000ppm) >240 Melphalan, 5mg/ml (5,000ppm) >240 Methotrexate, 25mg/ml (25,000ppm) >240 >240 Mitomycin, 0.5mg/ml (500ppm) 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
| Fentanyl Citrate | Minimum BDT (Minutes) |
|---|---|
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
- Please note that the following drugs have extremely low permeation times:
Carmustine: 21.2 minutes, Thiotepa: 36.3 minutes
Warning: Do not use with Carmustine and Thiotepa.
9
Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China
| Items | Subject Device
K240072 | Predicate Device
K213440 | Result of
comparison |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Trade Name | Powder Free Nitrile Examination
Gloves (Blue, Purple-Blue),
Tested for Use with
Chemotherapy Drugs and
Fentanyl Citrate | Powder Free Nitrile
Examination Gloves (Blue,
Purple-Blue), Tested for Use
with Chemotherapy Drugs | Different* |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC | Different* |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | 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. In
additiongloves were tested for use
with Chemotherapy drugs and
fentanyl citrate in accordance with
ASTM D6978. | 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. In
addition these gloves were tested
for use with Chemotherapy drugs
in accordance with ASTM
D6978. | Different* |
| Powder or Powder
Free | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Material use | Nitrile | Nitrile | Same |
| Color | Blue, Purple-Blue | Blue, Purple-Blue | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Single use | Single use | Single use | Same |
| Chemotherapy Drug
and Fentanyl Citrate
Permeation Claim | See below comparison table | See below comparison table | / |
7. Comparison of Technological Characteristics Between the Subject Device and Predicate Device
- The subject device and predicate device are exactly the same. The subject device was tested for use with Chemotherapy drugs and fentanyl citrate, but the predicate device was tested for use with Chemotherapy drugs only.
Dimensions and Performance Comparison Table:
| Technological
Characteristics | Subject Device
K240072 | Predicate Device
K213440 | Result of
comparison |
|----------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------|
| Length | Minimum 220mm for size
XS and S, 230mm for size
M, L, XL, XXL | Minimum 220mm for size XS
and S, 230mm for size M, L,
XL, XXL | Same |
| Palm Width (size) (mm) | | | |
| XS | $70\pm10$ | $70\pm10$ | Same |
| S | $80\pm10$ | $80\pm10$ | Same |
| M | $95\pm10$ | $95\pm10$ | Same |
10
Zhaokua Area, Luliang Industrial Zone, Qujing City,
Yunnan Province, 655606 China
| 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 |
| 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 | Same | ||
| 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 | Same | ||
| 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 | Same | ||
| ISO 10993 Part 11 | |||
| Systemic toxicity | 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 Permeation Comparison:
| Tested Chemotherapy Drug and Concentration | Minimum BDT (Minutes) | | Result of
comparison | | |
|--------------------------------------------|---------------------------|-------------|-------------------------|-----------------------------|------|
| | Subject Device
K240072 | | | Predicate Device
K213440 | |
| | Blue | Purple-Blue | Blue | Purple-Blue | |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | >240 | >240 | >240 | Same |
| Busulfan 6mg/ml (6,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Carmustine 3.3 mg/ml (3,300 ppm) | 25.5 | 21.2 | 25.5 | 21.2 | Same |
| Chloroquine 50mg/ml (50,000ppm) | >240 | >240 | >240 | >240 | Same |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | >240 | >240 | Same |
11
Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | >240 | >240 | Same |
|---|---|---|---|---|---|
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Docetaxel HCL, 10 mg/ml (10,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 | >240 | >240 | >240 | Same |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | >240 | >240 | Same |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 | >240 | >240 | >240 | Same |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | >240 | >240 | >240 | Same |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | >240 | >240 | >240 | Same |
| Irinotecan, 20mg/ml (20,000ppm) | >240 | >240 | >240 | >240 | Same |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | >240 | >240 | >240 | Same |
| Melphalan, 5mg/ml (5,000ppm) | >240 | >240 | >240 | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | >240 | >240 | Same |
| Mitomycin, 0.5mg/ml (500ppm) | >240 | >240 | >240 | >240 | Same |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | >240 | >240 | >240 | Same |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 | >240 | >240 | >240 | Same |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | >240 | >240 | Same |
| Paraplatin/Carboplatin, 10mg/ml (10,000ppm) | >240 | >240 | >240 | >240 | Same |
| Retrovir, 10mg/ml (10,000ppm) | >240 | >240 | >240 | >240 | Same |
| Rituximab, 10mg/ml (10,000ppm) | >240 | >240 | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 66.8 | 36.3 | 66.8 | 36.3 | Same |
| Topotecan, 1mg/ml (1,000ppm) | >240 | >240 | >240 | >240 | Same |
| Trisenox, 1mg/ml (1,000ppm) | >240 | >240 | >240 | >240 | Same |
| Velcade (Bortezomib) , 1mg/ml (1,000ppm) | >240 | >240 | >240 | >240 | Same |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | >240 | >240 | >240 | Same |
Fentanyl Citrate Permeation Comparison:
| Minimum BDT (Minutes) | |||||
|---|---|---|---|---|---|
| Fentanyl Citrate and Concentration | Subject Device | ||||
| K240072 | Predicate Device | ||||
| K213440 | Result of | ||||
| comparison | |||||
| Blue | Purple-Blue | Blue | Purple-Blue | ||
| Fentanyl Citrate Injection (100mcg/2mL) | >240 | >240 | / | / | Different* |
- The subject device and predicate device are exactly the same. The subject device was tested for use with Chemotherapy drugs and fentanyl citrate, but the predicate device was tested for use with Chemotherapy drugs only.
12
Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China
8. Summary of Non-Clinical Testing
Non-clinical tests were performed to verify that the subject device will meet the acceptance criteria of the performance test shown below:
| Referenced standards | Test Performed/Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Length | Minimum 220mm for size XS | |
| and S, 230mm for size M, L, | |||
| XL, XXL | Pass | ||
| ASTM D6319-19 | Physical Dimensions Palm | ||
| Width | XS: 70±10mm | ||
| S: 80±10mm | |||
| M: 95±10mm | |||
| L:110±10mm | |||
| XL: 120±10mm | |||
| XXL: 130±10mm | Pass | ||
| ASTM D6319-19 | Physical Dimensions Thickness | Finger: 0.05mm (min) | |
| Palm: 0.05mm (min) | Pass | ||
| ASTM D6319-19 | |||
| ASTM D412-16 (2021) | Physical Properties | Tensile Strength (Min14 Mpa) | |
| Elongation (Before Aging | |||
| 500% and after aging 400%) | |||
| Min | Pass | ||
| ASTM D6319-19 | |||
| ASTM D5151-19 | Freedom from holes | G-I, AQL 2.5 | Pass |
| ASTM D6319-19 | |||
| ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Chemotherapy Drugs, Opioid | ||
| Drug Permeation | Refer the above tables | Pass | |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skin | |
| irritation | Is non- | ||
| sensitization and | |||
| Non-irritation | |||
| ISO 10993-5:2009 | |||
| Cytotoxicity Test | Cytotoxicity Test | Under the conditions of | |
| this study, no cytotoxic | |||
| potential | Under the | ||
| conditions of this | |||
| study, the test | |||
| article extract | |||
| showed potential | |||
| toxicity | |||
| ISO 10993-11:2017 | |||
| systemic toxicity | Acute systemic toxicity | ||
| study | Subject showed no adverse | ||
| biological reaction | Under the | ||
| conditions of this | |||
| study, there was no | |||
| evidence of acute | |||
| systemic toxicity. |
9. Summary of Clinical Testing:
No clinical testing was submitted for the subject device.
10. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.