(230 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permention by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, blue colored, nitrile, and tested for use with chemotherapy drugs And Fentanyl Citrate. The design of the subject device is addressing the standards as ASTM D6124, ASTM D5151, ASTM D6319, ASTM D6978-05. The gloves have a minimum length of 270mm. The Subject device is nonsterile.
Below are the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Biocompatibility | |||
| Skin Sensitization Potential | Under the conditions of the testing, not a sensitizer. | Primary irritation indexes of polar and non-polar test group were both 0%. | Pass |
| Irritation Potential | Under the conditions of the testing, not an irritant. | Skin sensitization rates of polar and non-polar extract group were both 0%. | Pass |
| In Vitro Cytotoxicity Potential | Under the conditions of the testing, non-cytotoxic. | Cell viability of the 100% test article extract was 86.2%. | Pass |
| Physical Performance | |||
| Residual Powder on Medical Gloves | Powder residue limit of 2.0 mg/glove (ASTM D6124-06) | 1.9 mg/glove | Pass |
| Detection of Holes | AQL: 2.5 (ISO 2859-1) (ASTM D5151-19) | 0 gloves of failure | Pass |
| Physical Dimensions (ASTM D6319-19) | |||
| Length | ≥270 mm for all sizes (XS, S, M, L, XL, XXL) | Range: 287-301 mm (across sizes) | Pass |
| Width | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | XS: 78-80mm; S: 84-86mm; M: 96-97mm; L: 105-107mm; XL: 113-115mm; XXL: 122-124mm | Pass |
| Thickness (Finger) | ≥0.05 mm | 0.082-0.185 mm | Pass |
| Thickness (Palm) | ≥0.05 mm | 0.065-0.123 mm | Pass |
| Physical Properties: Before Aging (ASTM D6319-19 & ASTM D412-16) | |||
| Tensile Strength | ≥14 MPa | 19.9-28.9 MPa | Pass |
| Ultimate Elongation | ≥500% | 540-580% | Pass |
| Physical Properties: After Accelerated Aging (ASTM D6319-19 & ASTM D412-16 & ASTM D573-04) | |||
| Tensile Strength | ≥14 MPa | 20.2-29.1 MPa | Pass |
| Ultimate Elongation | ≥400% | 508-528% | Pass |
| Permeation Characteristics (ASTM D6978-05) | |||
| Carmustine (3.3 mg/ml) | Not explicitly stated as acceptance criteria, but listed as having a minimum breakthrough time in the indications for use. | 21.1 (24.2, 21.1, 25.3) min. (Note: Warning - Do not use) | N/A |
| Thiotepa (10 mg/ml) | Not explicitly stated as acceptance criteria, but listed as having a minimum breakthrough time in the indications for use. | 74.9 (74.9, 96.7, 79.0) min. (Note: Warning - Do not use) | N/A |
| Other Chemotherapy Drugs and Fentanyl Citrate | Generally, Breakthrough Detection Time > 240 minutes for most tested drugs. | > 240 minutes for most listed drugs (see full list in original document) | Pass |
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not explicitly state the sample size used for each specific test (e.g., number of gloves tested for permeation, holes, etc.). However, it refers to standard test methods like ASTM D6319-19 which would define typical sample sizes for such evaluations.
- Data provenance: The data is generated from non-clinical (bench) testing performed by the manufacturer or a contracted lab. The country of origin of the data is not specified beyond the manufacturer's address in Hebei, P.R. China. The data is prospective in nature, as it was generated to demonstrate device performance for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes non-clinical (bench) testing of physical properties and chemical permeation, not a study involving human expert interpretation for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the document describes non-clinical (bench) testing.
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:
This information is not applicable as the document describes non-clinical (bench) testing of a medical glove, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the document describes non-clinical (bench) testing of a medical glove, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests is established by industry standards and defined acceptance criteria. For example:
- Physical dimensions: Measured values compared against specified ranges (e.g., length ≥270mm).
- Physical properties (tensile strength, elongation): Measured values compared against minimum performance requirements defined in ASTM standards.
- Freedom from holes: Tested according to ASTM D5151-19, with acceptance based on AQL (Acceptable Quality Limit) of 2.5.
- Residual powder: Measured amount compared against a limit of < 2.0 mg/glove.
- Biocompatibility: Results of standardized biological evaluations (ISO 10993-10, ISO 10993-5) indicating non-sensitization, non-irritation, and non-cytotoxicity.
- Chemotherapy drug permeation: Breakthrough detection time measured according to ASTM D6978-05, compared against a maximum testing time of 240 minutes.
8. The sample size for the training set:
This information is not applicable as the document describes non-clinical (bench) testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the document describes non-clinical (bench) testing, not a machine learning model.
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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.
October 26, 2023
Zhonghong Pulin Medical Products Co.,Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K230662
Trade/Device Name: Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: September 26, 2023 Received: September 26, 2023
Dear Boyle Wang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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,
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director
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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) K230662
Device Name
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permention by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time (minutes) |
|---|---|---|
| Bendamustine HCl | 5 mg/ml (5,000 ppm) | > 240 |
| Bleomycin Sulfate | 15 mg/ml (15,000 ppm) | > 240 |
| Busulfan | 6 mg/ml(6,000 ppm) | > 240 |
| Carboplatin | 10.0 mg/ml (10,000 ppm) | > 240 |
| Carfilzomib | 2 mg/ml (2,000 ppm) | > 240 |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 21.1 (24.2, 21.1, 25.3) |
| Cetuximab | 2 mg/ml (2,000 ppm) | > 240 |
| Cisplatin | 1 mg/ml (1000 ppm) | > 240 |
| Cladribine | 1 mg/ml (1000 ppm) | > 240 |
| Cyclophosphamide | 20 mg/ml (20.000 ppm) | > 240 |
| Cytarabine(Cytosine) | 10 mg/ml(10,000 ppm) | > 240 |
| Cytovene(Ganciclovir) | 10 mg/ml(10,000 ppm) | > 240 |
| Dacarbazine | 10 mg/ml(10,000 ppm) | > 240 |
| Daunorubicin HCl | 5 mg/ml (5,000 ppm) | > 240 |
| Decitabine | 5 mg/ml(5,000 ppm) | > 240 |
| Docetaxel | 10 mg/ml (10.000 ppm) | > 240 |
| Doxorubicin HCl | 2 mg/ml (2,000 ppm) | > 240 |
| Epirubicin HCI (Ellence) | 20 mg/ml (20,000 ppm) | > 240 |
| Etoposide | 20 mg/ml (20,000 ppm) | > 240 |
| Fludarabine | 25.0 mg/ml (25,000 ppm) | > 240 |
| Fluorouracil | 50 mg/ml,(50,000 ppm) | > 240 |
| Fulvestrant | 50 mg/ml(50,000 ppm) | > 240 |
| Gemcitabine | 38 mg/ml (38,000 ppm) | > 240 |
| Idarubicin HCL | 1.0 mg/ml (1,000 ppm) | > 240 |
| lfosfamide | 50 mg/ml (50,000 ppm) | > 240 |
| Irinotecan HCI | 20 mg/ml (20,000 ppm) | > 240 |
| Mechlorethamine HCl | 1 mg/mI(1,000 ppm) | > 240 |
| Melphalan | 5 mg/ml(5000 ppm) | > 240 |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 |
| Mitoxantrone HCL | 2 mg/ml (2,000 ppm) | > 240 |
| Oxaliplatin | 5 mg/ml (5,000 ppm) | > 240 |
| Paclitaxel | 6 mg/ml (6,000 ppm) | > 240 |
| Paraplatin | 10 mg/ml (10,000 ppm) | > 240 |
| Pemetrexed | 25 mg/ml (25,000 ppm) | > 240 |
| Raltitrexed | 0.5 mg/ml (500 ppm) | > 240 |
| Rituximab | 10 mg/ml (10,000 ppm) | > 240 |
| Temsirolimus | 25 mg/ml (25,000 ppm) | > 240 |
| Thiotepa | 10 mg/ml(10,000 ppm) | 74.9 (74.9, 96.7, 79.0) |
| Topotecan | 1 mg/ml (1,000 ppm) | > 240 |
| Trisenox (Arsenic Trioxide) | 1 mg/ml (1,000 ppm) | > 240 |
| Vinblastine, | 1 mg/ml (1,000 ppm) | > 240 |
| Vincristine sulfate (Oncovin) | 1 g/ml (1,000 ppm) | > 240 |
| Vinorelbine | 10 mg/ml(10,000 ppm) | > 240 |
| Fentanyl Citrate and other Drugs | Concentration | Breakthrough Detection Time (minutes) |
| Chloroquine | 50 mg/ml (50,000 ppm) | > 240 |
| Cyclosporin A | 100.0 mg/ml (100,000 ppm) | > 240 |
| MESNA | 100 mg/ml(100,000 ppm) | > 240 |
| Retrovir | 10 mg/ml(10,000 ppm) | > 240 |
| Triclosan | 3 mg/ml(3,000 ppm) | > 240 |
| Zoledronic Acid | 1 mg/25ml (40 ppm) | > 240 |
| Fentanyl Citrate Injection | 100mcg/2mL | > 240 |
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Note: The maximum testing time is 240 minutes. And testing showed minimum breakthrough time of 21.1 minutes with Carmustine (3.3 mg/ml), 74.9 minutes with Thio Tepa (10 mg/ml). Warning: Do not use with Carmustine and Thiotepa.
Type of Use (Select one or both, as applicable)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/5/Picture/1 description: The image contains a logo for a company called "ZHONGHONG PULIN". The logo consists of two parts: a red square with the letters "Z" and "/" repeated inside, and the company name written in black text to the right of the square. The company name is written in two lines, with "ZHONGHONG" on the top line and "PULIN" on the bottom line.
510(k) Summary K230662
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Zhonghong Pulin Medical Products Co.,Ltd. Address: West Industrial Park, BDA, Luannan County, Tangshan City, 063500 Hebei, P.R. China. Phone Number: +86-18731635203 Contact: Li Yunjiao Date of Preparation: 2023.10.23
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove
3.0 Classification
Production code: LZA, LZC, OPJ, QDO Requlation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Name: Ever Global (Vietnam) Enterprise Corp. Device Trade Name:
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Image /page/6/Picture/1 description: The image contains a logo for a company called "ZHONGHONG PULIN". The logo consists of a red square with the letters "Z" and "Z" separated by a vertical line inside. To the right of the square, the company name "ZHONGHONG" is written in a larger, bolder font, with "PULIN" written below it in a smaller font.
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate 510(k) number: K193555
5.0 Indication for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time (minutes) |
|---|---|---|
| Bendamustine HCI | 5 mg/ml (5,000 ppm) | > 240 |
| Bleomycin Sulfate | 15 mg/ml (15,000 ppm) | > 240 |
| Busulfan | 6 mg/ml(6,000 ppm) | > 240 |
| Carboplatin | 10.0 mg/ml (10,000 ppm) | > 240 |
| Carfilzomib | 2 mg/ml (2,000 ppm) | > 240 |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 21.1 (24.2, 21.1, 25.3) |
| Cetuximab | 2 mg/ml (2,000 ppm) | > 240 |
| Cisplatin | 1 mg/ml (1000 ppm) | > 240 |
| Cladribine | 1 mg/ml (1000 ppm) | > 240 |
| Cyclophosphamide | 20 mg/ml (20.000 ppm) | > 240 |
| Cytarabine(Cytosine) | 10 mg/ml(10,000 ppm) | > 240 |
| Cytovene(Ganciclovir) | 100.0 mg/ml (100,000 ppm) | > 240 |
| Dacarbazine | 10 mg/ml(10,000 ppm) | > 240 |
| Daunorubicin HCI | 5 mg/ml (5,000 ppm) | > 240 |
| Decitabine | 5 mg/ml(5,000 ppm) | > 240 |
| Docetaxel | 10 mg/ml (10.000 ppm) | > 240 |
| Doxorubicin HCI | 2 mg/ml (2,000 ppm) | > 240 |
| Epirubicin HCI (Ellence) | 20 mg/ml (20,000 ppm) | > 240 |
| Etoposide | 20 mg/ml (20,000 ppm) | > 240 |
| Fludarabine | 25.0 mg/ml (25,000 ppm) | > 240 |
| Fluorouracil | 50 mg/ml (50,000 ppm) | > 240 |
| Fulvestrant | 50 mg/ml(50,000 ppm) | > 240 |
| Gemcitabine | 38 mg/ml (38,000 ppm) | > 240 |
| Idarubicin HCI | 1.0 mg/ml (1,000 ppm) | > 240 |
| Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 |
| Irinotecan HCI | 20 mg/ml (20,000 ppm) | > 240 |
| Mechlorethamine HCI | 1 mg/ml(1,000 ppm) | > 240 |
| Melphalan | 5 mg/ml(5000 ppm) | > 240 |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 |
| Mitoxantrone HCI | 2 mg/ml (2,000 ppm) | > 240 |
| Oxaliplatin | 5 mg/ml (5,000 ppm) | > 240 |
| Paclitaxel | 6 mg/ml (6,000 ppm) | > 240 |
| Paraplatin | 10 mg/ml (10,000 ppm) | > 240 |
| Pemetrexed | 25 mg/ml (25,000 ppm) | > 240 |
| Raltitrexed | 0.5 mg/ml (500 ppm) | > 240 |
| Rituximab | 10 mg/ml (10,000 ppm) | > 240 |
| Temsirolimus | 25 mg/ml (25,000 ppm) | > 240 |
| Thiotepa | 10 mg/ml(10,000 ppm) | 74.9 (74.9, 96.7, 79.0) |
| Topotecan | 1 mg/ml (1,000 ppm) | > 240 |
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Image /page/7/Picture/1 description: The image shows the logo for ZHONGHONG PULIN. The logo consists of a red square with the letters "Z" and "Z" separated by a vertical line inside. To the right of the square, the words "ZHONGHONG" are stacked on top of the word "PULIN".
| Concentration | Breakthrough Detection Time (minutes) | ||
|---|---|---|---|
| Trisenox (Arsenic Trioxide) | 1 mg/ml (1,000 ppm) | > 240 | |
| Vinblastine, | 1 mg/ml (1,000 ppm) | > 240 | |
| Vincristine sulfate (Oncovin) | 1 g/ml (1,000 ppm) | > 240 | |
| Vinorelbine | 10 mg/ml(10,000 ppm) | > 240 | |
| Fentanyl Citrate and other Drugs | |||
| Chloroquine | 50 mg/ml (50,000 ppm) | > 240 | |
| Cyclosporin A | 100.0 mg/ml (100,000 ppm) | > 240 | |
| MESNA | 100 mg/ml(100,000 ppm) | > 240 | |
| Retrovir | 10 mg/ml(10,000 ppm) | > 240 | |
| Triclosan | 3 mg/ml(3,000 ppm) | > 240 | |
| Zoledronic Acid | 1 mg/25ml (40 ppm) | > 240 | |
| Fentanyl Citrate Injection | 100mcg/2mL | > 240 |
Note: The maximum testing time is 240 minutes. And testing showed minimum breakthrough time of 21.1 minutes with Carmustine (3.3 mg/ml), 74.9 minutes with Thio Tepa (10 mg/ml).
Warning: Do not use with Carmustine and Thiotepa.
6.0 Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, blue colored, nitrile, and tested for use with chemotherapy drugs And Fentanyl Citrate. The design of the subject device is addressing the standards as ASTM D6124, ASTM D5151, ASTM D6319, ASTM D6978-05. The gloves have a minimum length of 270mm. The Subject device is nonsterile.
7.0 Comparison of Technical Characteristics
| Item | Subject device | Predicate device | Comparison |
|---|---|---|---|
| 510(k)number | Nitrile Exam Glove, Extended cuff,Tested For Use WithChemotherapy Drugs, FentanylCitrate, And Select Other Drugs | Disposable Powder Free NitrileExamination Glove, Blue Color,Tested For Use With ChemotherapyDrugs And Fentanyl Citrate | / |
| ProductCode | LZA, LZC, OPJ, QDO | LZA, LZC, QDO | Similar |
| RegulationNo. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| IndicationsFor Use | A patient examination gloves is adisposable device intended for medicalpurpose that is worn on the examiner'shand or fingers to prevent | A patient examination gloves is adisposable device intended formedical purpose that is worn on theexaminer's hand or fingers to | Similar |
| contamination between patient and examiner.In addition, these gloves were tested for use with chemotherapy drugs, Fentanyl Citrate, and select other drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.Chemotherapy Drug Concentration Breakthrough Detection Time (minutes) | prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.Test Chemotherapy Drug Concentration (mg/ml) Minimum Breakthrough Detection Time (Min.) | ||
| Bendamustine HCl 5 mg/ml (5,000 ppm) > 240 | 1 Arsenic Trioxide (1.0 mg/ml) > 240 | ||
| Bleomycin Sulfate 15 mg/ml (15,000 ppm) > 240 | 2 Azacitidine (Vidaza) (25.0 mg/ml) > 240 | ||
| Busulfan 6 mg/ml (6,000 ppm) > 240 | 3 Bendamustine HCl (5.0 mg/ml) > 240 | ||
| Carboplatin 10.0 mg/ml (10,000 ppm) > 240 | 4 Bleomycin Sulfate (15.0 mg/ml) > 240 | ||
| Carfilzomib 2 mg/ml (2,000 ppm) > 240 | 5 Bortezomib (Velcade) (1.0 mg/ml) > 240 | ||
| Carmustine 3.3 mg/ml (3,300 ppm) 21.1 (24.2, 21.1, 25.3) | 6 Busulfan (6.0 mg/ml) > 240 | ||
| Cetuximab 2 mg/ml (2,000 ppm) > 240 | 7 Carboplatin (10.0 mg/ml) > 240 | ||
| Cisplatin 1 mg/ml (1000 ppm) > 240 | 8 Carfilzomib (2.0 mg/ml) > 240 | ||
| Cladribine 1 mg/ml (1000 ppm) > 240 | 9 Carmustine (BCNU), (3.3 mg/ml) 6.2 | ||
| Cyclophosphamide 20 mg/ml (20.000 ppm) > 240 | 10 Cetuximab (Erbitux) (2.0 mg/ml) > 240 | ||
| Cytarabine(Cytosine) 10 mg/ml(10,000 ppm) > 240 | 11 Chloroquine (50.0 mg/ml) > 240 | ||
| Cytovene (Ganciclovir) 10 mg/ml(10,000 ppm) > 240 | 12 Cisplatin (1.0 mg/ml) > 240 | ||
| Dacarbazine 10 mg/ml (10,000 ppm) > 240 | 13 Cladribine (1.0 mg/ml) > 240 | ||
| Daunorubicin HCl 5 mg/ml (5,000 ppm) > 240 | 14 Cyclophosphamide (20.0 mg/ml) > 240 | ||
| Decitabine 5 mg/ml (5,000 ppm) > 240 | 15 Cyclosporine A (100.0 mg/ml) > 240 | ||
| Docetaxel 10 mg/ml (10.000 ppm) > 240 | 16 Cytarabine (100.0 mg/ml) > 240 | ||
| Doxorubicin HCl 2 mg/ml (2,000 ppm) > 240 | 17 Cytovene (Ganciclovir) (10.0 mg/ml) > 240 | ||
| Epirubicin HCl (Ellence) 20 mg/ml (20,000 ppm) > 240 | 18 Dacarbazine (10.0 mg/ml) > 240 | ||
| Etoposide 20 mg/ml (20,000 ppm) > 240 | 19 Daunorubicin (5.0 mg/ml) > 240 | ||
| Fludarabine 25.0 mg/ml (25,000 ppm) > 240 | 20 Decitabine (5.0 mg/ml) > 240 | ||
| Fluorouracil 50 mg/ml, (50,000 ppm) > 240 | 21 Docetaxel (10.0 mg/ml) > 240 | ||
| Fulvestrant 50 mg/ml(50,000 ppm) > 240 | 22 Doxorubicin Hydrochloride (2.0 mg/ml) > 240 | ||
| 23 Epirubicin (Ellence) (2.0 mg/ml) > 240 | |||
| 24 Etoposide (20.0 mg/ml) > 240 | |||
| 25 Fludarabine (25.0 mg/ml) > 240 | |||
| Gemcitabine 38 mg/ml (38,000 ppm)> 240 | 26 Fluorouracil (50.0 mg/ml) > 240 | 27 Fulvestrant (50.0 mg/ml) > 240 | |
| Idarubicin HCL 1.0 mg/ml (1,000 ppm)> 240 | 28 Gemcitabine (38.0 mg/ml) > 240 | ||
| Ifosfamide 50 mg/ml (50,000 ppm) | 29 Idarubicin (1.0 mg/ml) > 240 |
General Comparison Table
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image contains a logo with the letters "Z|Z" in white on a red square. To the right of the square, the words "ZHONGHONG" and "PULIN" are written in black, with "ZHONGHONG" on top of "PULIN". The logo appears to represent a company or organization named Zhonghong Pulin.
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image contains a logo for Zhonghong Pulin. The logo consists of a red square with the letters "Z" inside, separated by a vertical line. To the right of the square are the words "ZHONGHONG" on the top line and "PULIN" on the bottom line, both in a sans-serif font.
| Irinotecan HCl 20 mg/ml (20,000 ppm) > 240 | 30 Ifosfamide (50.0 mg/ml) > 240 |
|---|---|
| Mechlorethamine HCl 1 mg/ml(1,000 ppm) > 240 | 31 Irinotecan (20.0 mg/ml) > 240 |
| Melphalan 5 mg/ml (5000 ppm) > 240 | 32 Mechlorethamine HCl (1.0 mg/ml) > 240 |
| Methotrexate 25 mg/ml (25,000 ppm) > 240 | 33 Melphalan (5.0 mg/ml) > 240 |
| Mitomycin C 0.5 mg/ml (500 ppm) > 240 | 34 Methotrexate (25 mg/ml) > 240 |
| Mitoxantrone HCL 2 mg/ml (2,000 ppm) > 240 | 35 Mesna (100 mg/ml) > 240 |
| Oxaliplatin 5 mg/ml (5,000 ppm) > 240 | 36 Mitomycin C (0.5 mg/ml) > 240 |
| Paclitaxel 6 mg/ml (6,000 ppm) > 240 | 37 Mitoxantrone (2.0 mg/ml) > 240 |
| Paraplatin 10 mg/ml (10,000 ppm) > 240 | 38 Oxaliplatin (5.0 mg/ml) > 240 |
| Pemetrexed 25 mg/ml (25,000 ppm) > 240 | 39 Paclitaxel (6.0mg/ml) > 240 |
| Raltitrexed 0.5 mg/ml (500 ppm) > 240 | 40 Paraplatin (10.0 mg/ml) > 240 |
| Rituximab 10 mg/ml (10,000 ppm) > 240 | 41 Pemetrexed (25.0 mg/ml) > 240 |
| Temsirolimus 25 mg/ml (25,000 ppm) > 240 | 42 Pertuzumab (30.0 mg/ml) > 240 |
| Thiotepa 10 mg/ml(10,000 ppm) 74.9 (74.9, 96.7, 79.0) | 43 Raltitrexed (0.5 mg/ml) > 240 |
| Topotecan 1 mg/ml (1,000 ppm) > 240 | 44 Retrovir (10.0 mg/ml) > 240 |
| Trisenox (Arsenic Trioxide) 1 mg/ml (1,000 ppm) > 240 | 45 Rituximab (10.0 mg/ml) > 240 |
| Vinblastine, 1 mg/ml (1,000 ppm) > 240 | 46 Temsirolimus (25.0 mg/ml) > 240 |
| Vincristine sulfate (Oncovin) 1 g/ml (1,000 ppm) > 240 | 47 Thiotepa (10.0 mg/ml) 13.6 |
| Vinorelbine 10 mg/ml (10,000 ppm) > 240 | 48 Topotecan HCI (1.0 mg/ml) > 240 |
| Fentanyl Citrate and other DrugsConcentration BreakthroughDetection Time (minutes) | 49 Trastuzumab (21.0 mg/ml) > 240 |
| Chloroquine 50 mg/m (50,000 ppm) > 240 | 50 Triclosan (2.0 mg/ml) > 240 |
| Cyclosporin A 100.0 mg/ml (100,000 ppm) > 240 | 51 Trisenox (1.0 mg/ml) > 240 |
| MESNA 100 mg/ml(100,000 ppm) > 240 | 52 Vinblastine (1.0 mg/ml) > 240 |
| Retrovir 10 mg/ml(10,000 ppm) > 240 | 53 Vincristine Sulfate (1.0 mg/ml) > 240 |
| Triclosan 3 mg/ml(3,000 ppm) > 240 | 54 Vinorelbine (10.0 mg/ml) > 240 |
| Zoledronic Acid 1 mg/25ml (40 ppm) > 240 | 55 Zoledronic Acid (0.8 mg/ml) > 240 |
| Fentanyl Citrate Injection 100mcg/2mL > 240 | Warning: do not use withCarmustine and Thiotepa.The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time: |
| Note: The maximum testing time is 240 | Carmustine (BCNU), 3.3 mg/ml 6.2 minutesThiotepa, 10.0 mg/ml 13.6 minutes |
| Fentanyl Permeation ResistanceClaim - Under the testing conditionsof ASTM D6978-05, Fentanyl CitrateInjection (100mcg/2mL) was foundto have no breakthrough detectedup to 240 minutes. |
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image contains a logo for a company called "ZHONGHONG PULIN". The logo consists of two parts: a red square with the letters "Z" and "Z" separated by a vertical line, and the company name written in black text to the right of the square. The company name is written in two lines, with "ZHONGHONG" on the top line and "PULIN" on the bottom line.
| breakthrough time of 21.1 minutes withCarmustine (3.3 mg/ml), 74.9 minuteswith Thio Tepa (10 mg/ml).Warning: Do not use with Carmustineand Thiotepa. | |||
|---|---|---|---|
| Powdered orPower free | Powder free | Powder free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Main Material | Powder-Free Nitrile | Nitrile | Similar |
| Colors | Blue | Blue | Same |
Device Dimensions Comparison Table
| SubjectdeviceK230662 | Designation | Size (mm) | |||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | XXL | ||
| Length, mm | 287-293 | 288-297 | 287-300 | 290-297 | 283-301 | 292-300 | |
| Criteria | ≥270 | ≥270 | ≥270 | ≥270 | ≥270 | ≥270 | |
| Complywith ASTMD6319 | Results | Pass | Pass | Pass | Pass | Pass | Pass |
| Width, mm | 78-80 | 84-86 | 96-97 | 105-107 | 113-115 | 122-124 | |
| Criteria | 70±10 | 80±10 | 95±10 | 110±10 | 120±10 | 130±10 | |
| Results | Pass | Pass | Pass | Pass | Pass | Pass | |
| Thickness, mm: | |||||||
| Finger | (0.082-0.185) | ||||||
| Criteria | > 0.05 | ||||||
| Results | pass | ||||||
| Palm | (0.065-0.123) | ||||||
| Criteria | > 0.05 | ||||||
| Results | pass | ||||||
| Designation | Size (mm) | ||||||
| PredicateDevice(K193555) | XS | S | M | L | XL | ||
| Length, mm | ≥300 | ≥300 | ≥300 | ≥300 | ≥300 | ||
| Criteria | ≥220 | ≥220 | ≥230 | ≥230 | ≥230 | ||
| Results | Pass | Pass | Pass | Pass | Pass | ||
| Width, mm | 70±10 | 80±10 | 95±10 | 110±10 | 120±10 | ||
| Criteria | 70±10 | 80±10 | 95±10 | 110±10 | 120±10 | ||
| Results | Pass | Pass | Pass | Pass | Pass | ||
| Complywith ASTMD6319 | Thickness, mm: | ||||||
| Finger | 0.05mm min. | ||||||
| Criteria | > 0.05 | ||||||
| Results | pass | ||||||
| Palm | 0.05mm min. | ||||||
| Criteria | > 0.05 | ||||||
| Results | pass | ||||||
| Remarks | Similar. The subject gloves have a minimum length of 270mm. |
Performance Comparison Table
| Item | Subject deviceK230662 | Predicate device(K193555) | Remark |
|---|---|---|---|
| ------ | --------------------------- | ------------------------------- | -------- |
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image contains a logo for "ZHONGHONG PULIN". The logo consists of a red square with the letters "Z" and "Z" separated by a vertical line inside. To the right of the square, the words "ZHONGHONG" are stacked above the word "PULIN".
| PhysicalProperties | Comply with ASTMD6319 | Comply with ASTMD6319 | Same | |||||
|---|---|---|---|---|---|---|---|---|
| BeforeAging | TensileStrength | (19.9-28.9)MPa | 14MPa, min | Same | ||||
| Criteria | 14MPa, min | 14MPa, min | ||||||
| Results | Pass | Pass | ||||||
| UltimateElongation | (540-580)% | 500% min | Same | |||||
| Criteria | 500% min | 500% min | ||||||
| Results | Pass | Pass | ||||||
| AfterAging | Tensile Strength | (20.2-29.1)MPa | 14MPa, min | Same | ||||
| Criteria | 14MPa, min | 14MPa, min | ||||||
| Results | Pass | Pass | ||||||
| Ultimate Elongation | (508-528)% | 400%min | Same | |||||
| Criteria | 400%min | 400%min | ||||||
| Results | Pass | Pass | ||||||
| Freedom from Holes | accordance withASTMD5151 | accordance withASTMD5151 | Same | |||||
| Criteria | AQL: 2.5 (ISO 2859) | G-1, AQL 2.5 | ||||||
| Results | 0 gloves of failurePass | Pass | ||||||
| Powder Content | Meet the requirements ofASTM D6319 | Meet the requirements ofASTM D6319 | Same | |||||
| Criteria | < 2.0mg per glove | < 2.0mg per glove | ||||||
| Results | 1.9 mg/glovePass | Pass | ||||||
| Chemotherapy Drugs andFentanyl Citrate InjectionTested with MinimumBreakthrough DetectionTime as Tested per ASTMD6978 | Bendamustine HCl5 mg/ml (5,000 ppm)> 240 min. | Bendamustine HCl(5.0 mg/ml)> 240 min. | Same | |||||
| Bleomycin Sulfate15 mg/ml (15,000 ppm)> 240 min. | Bleomycin Sulfate15 mg/ml> 240 min. | Same | ||||||
| Busulfan6 mg/ml(6,000 ppm)> 240 min. | Busulfan6 mg/ml> 240 min | Same | ||||||
| Carboplatin10.0 mg/ml (10,000 ppm)> 240 min. | Carboplatin10 mg/ml> 240 min. | Same | ||||||
| Carfilzomib2 mg/ml (2,000 ppm)> 240 min. | Carfilzomib(2.0 mg/ml)> 240 min. | Same | ||||||
| Carmustine3.3 mg/ml (3,300 ppm)21.1 (24.2, 21.1, 25.3)min. | Carmustine (BCNU)3.3 mg/ml37.5 min. | Similar | ||||||
| Cetuximab2 mg/ml (2,000 ppm)> 240 min. | Cetuximab (Erbitux)(2.0 mg/ml)> 240 min. | Same | ||||||
| Chloroquine50 mg/ml (50,000 ppm)> 240 min. | Chloroquine(50.0 mg/ml)> 240 min. | Same | ||||||
| Cisplatin1 mg/ml(1,000 ppm)> 240 min. | Cisplatin1.0 mg/ml> 240 min. | Same | ||||||
| Cladribine1 mg/ml (1000 ppm)> 240 min. | Cladribine(1.0 mg/ml)> 240 min. | Same | ||||||
| > 240 min. | Cyclophosphamide20 mg/ml (20.000 ppm)> 240 min. | > 240 min. | Cyclophosphamide(20.0 mg/ml)> 240 min | Same | ||||
| Cyclosporin A | Cyclosporin A | Same |
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image contains a logo for a company called "ZHONGHONG PULIN". The logo consists of a red square with the letters "Z" and "Z" separated by a vertical line. To the right of the square, the company name is written in black, with "ZHONGHONG" on the top line and "PULIN" on the bottom line.
| 100 mg/ml (100,000 ppm)> 240 min. | (100.0 mg/ml)> 240 min. | ||||
|---|---|---|---|---|---|
| Cytarabine(Cytosine)100.0 mg/ml (100,000 ppm)> 240 min. | Cytarabine(100.0 mg/ml)> 240 min | Same | |||
| Cytovene(Ganciclovir)10 mg/ml(10,000 ppm)> 240 min. | Cytovene (Ganciclovir)(10.0 mg/ml)> 240 min. | Same | |||
| Dacarbazine10 mg/ml(10,000 ppm)> 240 min. | Dacarbazine (DTIC)10.0 mg/ml> 240 min. | Same | |||
| Daunorubicin HCl5 mg/ml (5,000 ppm)> 240 min. | Daunorubicin5 mg/mL> 240 min. | Same | |||
| Decitabine5 mg/ml(5,000 ppm)> 240 min. | Decitabine(5.0 mg/ml)> 240 min. | Same | |||
| Docetaxel10 mg/ml (10.000 ppm)> 240 min. | Docetaxel10.0 mg/ml> 240 min | Same | |||
| Doxorubicin HCl2 mg/ml (2,000 ppm)> 240 min. | Doxorubicin HCl2.0 mg/ml:> 240 min | Same | |||
| Epirubicin HCl (Ellence)2 mg/ml (2,000 ppm)> 240 min. | Epirubicin (Ellence)2.0 mg/ml> 240 min. | Same | |||
| Etoposide20 mg/ml (20,000 ppm)> 240 min. | Etoposide,(20.0 mg/ml)> 240 min. | Same | |||
| Fludarabine25.0 mg/ml (25,000 ppm)> 240 min. | Fludarabine25.0 mg/ml> 240 min. | Same | |||
| Fluorouracil50 mg/ml,(50,000 ppm)> 240 min. | Fluorouracil50.0 mg/ml:> 240 min | Same | |||
| Fulvestrant50 mg/ml(50,000 ppm)> 240 min. | Fulvestrant(50.0 mg/ml)> 240 min | Same | |||
| Gemcitabine38 mg/ml (38,000 ppm)> 240 min. | Gemcitabine38 mg/ml> 240 min. | Same | |||
| Idarubicin HCl1.0 mg/ml (1,000 ppm)> 240 min. | Idarubicin1 mg/ml> 240 min. | Same | |||
| Ifosfamide50 mg/ml (50,000 ppm)> 240 min. | Ifosfamide50.0 mg/ml> 240 min. | Same | |||
| Irinotecan HCl20 mg/ml (20,000 ppm)> 240 min. | Irinotecan20.0 mg/ml> 240 min. | Same | |||
| Mechlorethamine HCl1 mg/ml(1,000 ppm)> 240 min. | Mechlorethamine HCI1.0 g/ml> 240 min. | Same | |||
| Melphalan5 mg/ml(5000 ppm)> 240 min. | Melphalan5 mg/ml> 240 min. | Same | |||
| Methotrexate | 25 mg/ml (25,000 ppm)> 240 min. | Methotrexate | 25 mg/ml> 240 min. | Same | |
| MESNA100 mg/ml(100,000 ppm) | Mesna(100 mg/ml) | Same |
{13}------------------------------------------------
Image /page/13/Picture/1 description: The image shows the logo for ZHONGHONG PULIN. The logo consists of a red square with the letters "Z|Z" in white, followed by the text "ZHONGHONG" in black, and then "PULIN" in black below it. The logo is simple and modern, with a clear and easy-to-read font.
| > 240 min. | > 240 min. | |
|---|---|---|
| Mitomycin C | Mitromycin C. | Same |
| 0.5 mg/ml (500 ppm) | 0.5 mg/ml | |
| > 240 min. | > 240 | |
| Mitoxantrone HCL | Mitoxantrone | Same |
| 2 mg/ml (2,000 ppm) | 2.0 mg/ml | |
| > 240 min. | > 240 min. | |
| Oxaliplatin | Oxaliplatin | Same |
| 5 mg/ml (5,000 ppm) | 5 mg/ml | |
| > 240 min. | > 240 min. | |
| Paclitaxel | Paclitaxel (Taxol) | Same |
| 6 mg/ml (6,000 ppm) | 6.0 mg/ml | |
| > 240 min. | > 240 min. | |
| Paraplatin | Paraplatin | Same |
| 10 mg/ml (10,000 ppm) | 10 mg/ml | |
| > 240 min. | > 240 min. | |
| Pemetrexed | Pemetrexed | Same |
| 25 mg/ml (25,000 ppm) | (25.0 mg/ml) | |
| > 240 min. | > 240 min. | |
| Raltitrexed | Raltitrexed | Same |
| 0.5 mg/ml (500 ppm) | (0.5 mg/ml) | |
| > 240 min. | > 240 min. | |
| Retrovir | Retrovir | Same |
| 10 mg/ml(10,000 ppm) | 10 mg/ml | |
| > 240 min. | > 240 min. | |
| Rituximab | Rituximab | Same |
| 10 mg/ml (10,000 ppm) | 10.0 mg/ml | |
| > 240 min. | > 240 min. | |
| Temsirolimus | Temsirolimus | Same |
| 25 mg/ml (25,000 ppm) | (25.0 mg/ml) | |
| > 240 min. | > 240 min. | |
| Thiotepa | Thiotepa | Similar |
| 10 mg/ml(10,000 ppm) | 10.0 mg/ml | |
| 74.9 (74.9, 96.7, 79.0)min. | 13.6min. | |
| Topotecan | Topotecan HCl | Same |
| 1 mg/ml (1,000 ppm) | (1.0 mg/ml) | |
| > 240 min. | > 240 min. | |
| Triclosan | Triclosan | Similar |
| 3 mg/ml(3,000 ppm) | (2.0 mg/ml) | |
| > 240 min. | > 240 min. | |
| Trisenox (Arsenic Trioxide) | Trisenox | Same |
| 1 mg/ml (1,000 ppm) | 1.0 mg/ml | |
| > 240 min. | > 240 min. | |
| Vinblastine, | Vinblastine, | Same |
| 1 mg/ml (1,000 ppm) | 1 mg/ml (1,000 ppm) | |
| > 240 min. | > 240 min. | |
| Vincristine sulfate (Oncovin)1 g/ml (1,000 ppm) | Vincristine Sulfate | Same |
| > 240 min. | 1.0 mg/ml | |
| > 240 min. | ||
| Vinorelbine | Vinorelbine | Same |
| 10 mg/ml(10,000 ppm) | 10 mg/ml | |
| > 240 min. | > 240 min. | |
| Zoledronic Acid | Zoledronic Acid | Similar |
| 1 mg/25ml (40 ppm) | (0.8 mg/ml) | |
| > 240 min. | > 240 min. | |
| Fentanyl Citrate Injection | Fentanyl Citrate Injection, | Same |
| 100mcg/2mL | (100 mcg/2ml) | |
| > 240 min. | > 240 min |
{14}------------------------------------------------
Image /page/14/Picture/1 description: The image contains a logo with the text "ZHONGHONG PULIN". To the left of the text is a red square with two white Z's separated by a vertical line. The text is in a simple, sans-serif font and is aligned to the right of the square. The overall design is clean and professional.
| Items | Predicate device | Subject device | Remark | |
|---|---|---|---|---|
| (K193555) | K230662 | |||
| Material | Nitrile | Nitrile compounds | Similar | |
| Bio-compatibility | Irritation | Comply with ISO10993-10Under the conditions of thestudy, not an irritant | Comply with ISO10993-10Under the conditions of thestudy, not an irritant | Similar |
| Sensitization | Comply with ISO10993-10Under conditions of the study,not a sensitizer. | Comply with ISO10993-10Under conditions of the study,not a sensitizer. | ||
| Cytotoxicity | Comply with ISO10993-5 | Comply with ISO10993-5 | Similar | |
| Extraction conditions:37°C and 72 hours | Test conditions:No descriptions in summary | |||
| Under the conditions of thestudy, the device is not showncytotoxicity | Under conditions of the study,not cytotoxic |
bi
8.0 Summary of Non-Clinical Testing
Biocompatibility Testing
The biocompatibility evaluation for Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs was conducted in accordance 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
Performance Testing (Bench)
Physical performance qualities of the Subject device were evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing was conducted according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs to support the addition of the labeling claim: Tested for use with chemotherapy drugs, fentanyl citrate, and select other drugs.
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for -
{15}------------------------------------------------
Image /page/15/Picture/1 description: The image contains a logo for Zhonghong Pulin. The logo consists of a red square with the letters "Z" and a vertical line inside, followed by the text "ZHONGHONG" on one line and "PULIN" on the line below. The text is in a simple, sans-serif font and is black.
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.
- Assessment Of Resistance To Permeation By Chemotherapy Drugs - And Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| No. | Purpose of theTest | Standard | Acceptance Criteria | Results | Summary |
|---|---|---|---|---|---|
| Methodology | |||||
| 1 | Test for skinsensitizationpotential | ISO10993-10:2010 Biological | Under the conditions of the testing,not a sensitizer | The primary irritation indexes of the polar andnon-polar test group were both calculated to be 0. | Pass |
| 2 | Test for Irritationpotential | Evaluation OfMedical Devices- Part 10 | Under the conditions of the testing,not an irritant. | The skin sensitization rates of polar and non-polar extract group were both determined with 0%. | Pass |
| 3 | Evaluate In VitroCytotoxicitypotential | ISO10993-5:2009 | Under the conditions of the testing,non-cytotoxic. | The cell viability of the100% test article extractwas 86.2% | Pass |
| 4 | Measure residualpowder onmedical gloves | ASTM D6124-06(Reapproved2017) | powder residue limit of 2.0mg/glove | 1.9 mg/glove | Pass |
| 5 | Detection ofholes in medicalgloves | ASTM D5151-19 | Freedom free holes AQL: 2.5 (ISO2859-1) | 0 gloves of failure | Pass |
| 6 | Evaluate physicaldimensions | ASTM D6319-19, (7.4 &ASTM D3767-03(2 020)) | XS: width 70±10mm Length ≥270mm | Length: 287-293 mmWidth: 78-80mm | Pass |
| S: width 80±10mm Length ≥270mm | Length: 288-297 mmWidth: 84-86mm | Pass | |||
| M: width 95±10mm Length ≥270mm | Length: 287-300mmWidth: 96-97mm | Pass | |||
| L: width 110±10mm Length ≥270mm | Length: 290-297 mmWidth: 105-107mm | Pass | |||
| XL: width 120±10mm Length ≥270mm | Length: 283-301 mmWidth: 113-115mm | Pass | |||
| XXL: width 130±10mm Length≥270 mm | Length: 292-300 mmWidth: 122-124mm | Pass | |||
| Thickness | Finger ≥0.05 mm Palm ≥0.05 mm | Finger :0.082-0.185mmPalm: 0.065-0.123mm | Pass | ||
| Evaluate physical properties: Before aging | |||||
| Tensile strength | ASTM D6319- | ≥14MPa | (19.9-28.9)MPa | Pass | |
| Ultimate | 19, | ≥500% | (540-580)% | Pass | |
| Elongation | 7.5& ASTMD412-16 (2021) | ||||
| After Accelerated Aging | |||||
| Tensile strength | ASTM D6319- | ≥14MPa | (20.2-29.1)MPa | Pass | |
| Ultimate | 19, 7.5& ASTM | ≥400% | (508-528)% | Pass | |
| Elongation | D412-16 (2021)&ASTM D573-04 (2019) | ||||
| 7 | Evaluatepermeationcharacteristics | ASTM D6978 | Bendamustine HCI5 mg/ml (5,000 ppm)> 240 min. | > 240 min. | |
| me | Bleomycin Sulfate15 mg/ml (15,000 ppm)> 240 min. | > 240 min. | |||
| Busulfan6 mg/ml(6,000 ppm)> 240 min. | > 240 min. | ||||
| Carboplatin10.0 mg/ml (10,000 ppm)> 240 min. | > 240 min. | ||||
| Carfilzomib2 mg/ml (2,000 ppm)> 240 min. | > 240 min. | ||||
| Carmustine3.3 mg/ml (3,300 ppm)21.1 (24.2, 21.1, 25.3)min. | 21.1 min | ||||
| Cetuximab2 mg/ml (2,000 ppm)> 240 min. | > 240 min. | ||||
| Chloroquine50 mg/m (50,000 ppm)> 240 min. | > 240 min. | ||||
| Cisplatin1 mg/ml(1,000 ppm)> 240 min. | > 240 min. | ||||
| Cladribine1 mg/ml (1000 ppm)> 240 min. | > 240 min. | ||||
| Cyclophosphamide20 mg/ml (20.000 ppm)> 240 min. | > 240 min. | ||||
| Cyclosporin A100 mg/ml (100,000 ppm)> 240 min. | > 240 min. | ||||
| Cytarabine(Cytosine)100.0 mg/ml (100,000 ppm)> 240 min. | > 240 min. | ||||
| Cytovene(Ganciclovir)10 mg/ml(10,000 ppm)> 240 min. | > 240 min. | ||||
| Dacarbazine10 mg/ml(10,000 ppm)> 240 min. | > 240 min. | ||||
| Daunorubicin HCI5 mg/ml (5,000 ppm)> 240 min. | Decitabine5 mg/ml(5,000 ppm)> 240 min. | > 240 min. | > 240 min. | ||
| Docetaxel10 mg/ml (10.000 ppm)> 240 min. | > 240 min. | ||||
| Doxorubicin HCI2 mg/ml (2,000 ppm)> 240 min. | > 240 min. | ||||
| Epirubicin HCI (Ellence)2 mg/ml (2,000 ppm)> 240 min. | > 240 min. | ||||
| Etoposide20 mg/ml (20,000 ppm)> 240 min. | > 240 min. | ||||
| Fludarabine25.0 mg/ml (25,000 ppm)> 240 min. | > 240 min. | ||||
| Fluorouracil | > 240 min. | ||||
| 50 mg/ml,(50,000 ppm) | |||||
| > 240 min. | |||||
| Fulvestrant | > 240 min. | ||||
| 50 mg/ml(50,000 ppm) | |||||
| > 240 min. | |||||
| Gemcitabine | > 240 min. | ||||
| 38 mg/ml (38,000 ppm) | |||||
| > 240 min. | |||||
| Idarubicin HCL | > 240 min. | ||||
| 1.0 mg/ml (1,000 ppm) | |||||
| > 240 min. | |||||
| Ifosfamide | > 240 min. | ||||
| 50 mg/ml (50,000 ppm) | |||||
| > 240 min. | |||||
| Irinotecan HCI | > 240 min. | ||||
| 20 mg/ml (20,000 ppm) | |||||
| > 240 min. | |||||
| Mechlorethamine HCI | > 240 min. | ||||
| 1 mg/ml(1,000 ppm) | |||||
| > 240 min. | |||||
| Melphalan | > 240 min. | ||||
| 5 mg/ml(5000 ppm) | |||||
| > 240 min. | |||||
| Methotrexate | > 240 min. | ||||
| 25 mg/ml (25,000 ppm) | |||||
| > 240 min. | |||||
| MESNA | > 240 min. | ||||
| 100 mg/ml(100,000 ppm) | |||||
| > 240 min. | |||||
| Mitomycin C | > 240 min. | ||||
| 0.5 mg/ml (500 ppm) | |||||
| > 240 min. | |||||
| Mitoxantrone HCL | > 240 min. | ||||
| 2 mg/ml (2,000 ppm) | |||||
| > 240 min. | |||||
| Oxaliplatin | > 240 min. | ||||
| 5 mg/ml (5,000 ppm) | |||||
| > 240 min. | |||||
| Paclitaxel | > 240 min. | ||||
| 6 mg/ml (6,000 ppm) | |||||
| > 240 min. | |||||
| Paraplatin | > 240 min. | ||||
| 10 mg/ml (10,000 ppm) | |||||
| > 240 min. | |||||
| Pemetrexed | > 240 min. | ||||
| 25 mg/ml (25,000 ppm) | |||||
| > 240 min. | |||||
| Raltitrexed | > 240 min. | ||||
| 0.5 mg/ml (500 ppm) | |||||
| > 240 min. | |||||
| Retrovir | > 240 min. | ||||
| 10 mg/ml(10,000 ppm) | |||||
| > 240 min. | |||||
| Rituximab | > 240 min. | ||||
| 10 mg/ml (10,000 ppm) | |||||
| > 240 min. | |||||
| Temsirolimus | > 240 min. | ||||
| 25 mg/ml (25,000 ppm) | |||||
| > 240 min. | |||||
| Thiotepa | 10 mg/ml(10,000 ppm) | 74.9 min. | |||
| 74.9 (74.9, 96.7, 79.0)min. | |||||
| Topotecan | > 240 min. | ||||
| 1 mg/ml (1,000 ppm) |
Table 1 Summary of Non-Clinical Testing
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Image /page/16/Picture/1 description: The image contains a logo for "ZHONGHONG PULIN". The logo consists of a red square with the letters "Z" and "/" repeated inside. To the right of the square, the words "ZHONGHONG" are stacked on top of the word "PULIN". The text is in a simple, sans-serif font.
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Image /page/17/Picture/1 description: The image contains a logo for a company called "ZHONGHONG PULIN". The logo consists of two parts: a red square with the letters "Z" and "Z" separated by a vertical line, and the company name written in black text to the right of the square. The company name is written in two lines, with "ZHONGHONG" on the top line and "PULIN" on the bottom line.
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Image /page/18/Picture/1 description: The image contains a logo for Zhonghong Pulin. The logo consists of a red square with the letters "Z" and a vertical line separating them. To the right of the square are the words "ZHONGHONG" in a larger font and "PULIN" in a smaller font below it. The text is in a sans-serif font and is black.
| > 240 min. | > 240 min. | |
|---|---|---|
| Triclosan3 mg/ml(3,000 ppm)> 240 min. | > 240 min. | |
| Trisenox (Arsenic Trioxide)1 mg/ml (1,000 ppm)> 240 min. | > 240 min. | |
| Vinblastine,1 mg/ml (1,000 ppm)> 240 min. | > 240 min. | |
| Vincristine sulfate (Oncovin)1 g/ml (1,000 ppm)> 240 min. | > 240 min. | |
| Vinorelbine10 mg/ml(10,000 ppm)> 240 min. | > 240 min. | |
| Zoledronic Acid1 mg/25ml (40 ppm)> 240 min. | > 240 min. | |
| Fentanyl Citrate Injection100mcg/2mL> 240 min. | > 240 min. |
9.0 Summary of Clinical Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs is as safe, as effective, and performs as well as or better than the legally marketed predicate device K193555.
§ 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.