(116 days)
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.
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).
This is an evaluation of Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs (K213440).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are presented in the following table, derived from the "510(K) SUMMARY" (pages 11-12 of the document).
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Length | Minimum 230mm | All sizes ≥ 230mm |
| ASTM D6319-19 | Palm Width | XS: 70±10mmS: 80±10mmM: 95±10mmL: 110±10mmXL: 120±10mmXXL: 130±10mm | XS: 77-78mmS: 86-88mmM: 96-98mmL: 108-110mmXL: 116-117mmXXL: 126-127mm |
| ASTM D6319-19 | Thickness | Finger: 0.05mm (min)Palm: 0.05mm (min) | Finger: ≥ 0.05mmPalm: ≥ 0.05mm |
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, Before Aging | 14MPa, min | ≥ 14 MPa |
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, After Accelerated Aging | 14MPa, min | ≥ 14 MPa |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, Before Aging | 500%, min | ≥ 500% |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, After Accelerated Aging | 400%, min | ≥ 400% |
| ASTM D5151-19, ASTM D6319-19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL 2.5 requirements |
| ASTM D6124-06 (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 (or no cytotoxic potential from predicate) | 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 | (Implicitly, minimum breakthrough times (BDT) as presented in the tables for blue and purple-blue gloves) | Details refer to the above 5.0 result (pages 6-7, 2-3 of the document for breakdown of BDT for each drug) |
2. Sample size used for the test set and data provenance
The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., for physical properties, biocompatibility, or chemotherapy drug permeation). It mentions that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" (page 11).
The data provenance is not explicitly stated in terms of country of origin for the testing data or whether it was retrospective or prospective. However, the manufacturer is Luliang Hongruida Health Protection Technology Co., Ltd. (China), and the "510(K) Summary" indicates that the testing was performed to verify the device's compliance with established international and US standards (ASTM, ISO). This suggests the testing was performed specifically for the purpose of this submission (prospective in that sense).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission is for medical gloves and involves non-clinical performance testing against established standards (e.g., ASTM, ISO), which do not typically require expert consensus for ground truth establishment in the way AI/CADe devices do. The "ground truth" is defined by the technical specifications of the standards themselves (e.g., a specific tensile strength value, acceptable limits for holes, or breakthrough time metrics).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As noted above, this device does not involve a diagnostic or interpretive task that would require human expert adjudication. The tests performed are objective measurements against defined criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical glove, a physical device, not an AI/CADe system. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical and chemical properties (e.g., tensile strength, freedom from holes, powder content, biocompatibility, chemotherapy drug permeation), the "ground truth" is established by the specified test methods and their defined acceptance criteria (e.g., ASTM D6319-19, ASTM D6978-05, ISO 10993 series). These are objective, measurable standards, not subject to subjective interpretation or expert consensus in the typical sense of medical image analysis. For chemotherapy drug permeation, the "ground truth" is the measured breakthrough time for each drug using the ASTM D6978-05 standard.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an algorithm that requires a training set. The performance data is derived from specific tests on samples of the manufactured gloves.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a physical device, no ground truth was established for it.
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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
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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 |
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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.
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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 |
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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
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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 DeviceK213440 | Predicate DeviceK182600 | Remark | |
|---|---|---|---|
| Trade Name | Powder Free NitrileExamination Gloves(Blue, Purple-Blue),Tested for Use withChemotherapy Drugs | Powder Free NitrileExamination Gloves,Tested for Use withChemotherapy 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 NitrileExamination Gloves (Blue,Purple-Blue), Tested for Usewith Chemotherapy Drugs isa disposable device intendedfor medical purposes that isworn on the examiner's handto prevent contaminationbetween patient and examiner. | Powder Free NitrileExamination Gloves, Tested forUse with Chemotherapy Drugs(Blue) is a disposable deviceintended for medical purposesthat is worn on the examiner'shand to prevent contaminationbetween patient and examiner. | Same |
| Powder or PowderFree | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Blue, Purple-Blue | Blue | Similar |
| LabelingInformation | Single-use, powder freeglove size, quantity,Nitrile ExaminationGloves, Non Sterile | Single-use, powder free glovesize, quantity, NitrileExamination Gloves, NonSterile | Same |
| Chemotherapy DrugPermeation Claim | See below comparisontable | See below comparison table | Same |
General Comparison Table:
Dimensions and Performance Comparison Table:
| Technological | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| --------------- | ----------------- | ------------------ | -------- |
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| 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, AfterAccelerated Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation,After AcceleratedAging | 400%, min | 400%, min | Same |
| Freedom from holes | In accordance withASTM D 5151-19,following ASTM D6319- 19,G-I, AQL 2.5 | In accordance withASTM 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 SkinIrritation Study | Under the conditions of thestudy, not an irritant | Under the conditions of thestudy, not an irritant | Same |
| 10993-10:2010MaximizationSensitization Study | Under the conditions of thestudy, not a sensitizer | Under the conditions of thestudy, not a sensitizer | Same |
| 10993-5:2009Cytotoxicity Test | Under the conditions of thisstudy, the test article extractshowed potential toxicity | Under the conditions ofthis study, no cytotoxicpotential | Same |
| ISO 10993 Part 11Systemic toxicity | Under the conditions of thisstudy, there was no evidence ofsystemic 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 DeviceK213440 | Predicate DeviceK182600 | 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 D6319-19ASTN D412-16 | Tensile Strength, BeforeAging | 14MPa, min | ≥14 MPa |
| ASTM D6319-19ASTN D412-16 | Tensile Strength, AfterAccelerated Aging | 14MPa, min | ≥14 MPa |
{12}------------------------------------------------
Zhaokua Area, Luliang Industrial Zone, Qujing City, Yunnan Province, 655606 China
| 510(K) SUMMARY | |||
|---|---|---|---|
| ASTM D6319-19ASTN D412-16 | Ultimate Elongation,Before Aging | 500%, min | ≥500% |
| ASTM D6319-19ASTN D412-16 | Ultimate Elongation,After Accelerated Aging | 400%, min | ≥400% |
| ASTM D 5151-19ASTM D6319- 19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5requirements |
| 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 ofthe study, not an irritant | Under the conditions ofthe study, not an irritant |
| ISO 10993-10:2010 | MaximizationSensitization Study | Under the conditions ofthe study, not a sensitizer | Under the conditions ofthe study, not a sensitizer |
| ISO 10993-5:2009 | Cytotoxicity Test | Under the conditions ofthis study, the test articleextract showed potentialtoxicity | Under the conditions of thisstudy, the test article extractshowed potential toxicity |
| ISO 10993-11:2017 | Systemic toxicity | Under the conditions ofthis study, there was noevidence of systemictoxicity. | Under the conditions of thisstudy, there was no evidenceof systemic toxicity. |
| ASTM D6978-05 (2019) | Tested for Use withChemotherapy Drugs | / | Details refer to the above 5.0result |
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.
§ 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.