(86 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Powder Free Nitrile Examination Gloves (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, 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). The gloves are single use, disposable, and provided non-sterile.
This document describes a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This is a Class I medical device, which means it is subject to general controls and does not require approval of a premarket approval application (PMA). The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K192954).
The acceptance criteria and study proving the device meets these criteria are based on non-clinical performance data, as no clinical performance data was provided or required for this device type.
Acceptance Criteria and Device Performance Study
The device's performance was evaluated against various ASTM and ISO standards for medical examination gloves, particularly focusing on their physical properties and resistance to permeation by chemotherapy drugs and Fentanyl Citrate.
1. Table of Acceptance Criteria and Reported Device Performance
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions: Length | Minimum 230mm for all sizes | 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 & Elongation) | Tensile Strength (Min 14 MPa), Elongation (Before Aging 500% min, After Aging 400% min), Min AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water Leak Test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs | Refer to specific Minimum Breakthrough Detection Time (BDT) for each drug (as listed in section "Chemotherapy Permeation and Fentanyl Citrate Comparison Claim" on pages 8-9 of the document). For most drugs, the criterion is >240 minutes, with the exception of Carmustine and Thio Tepa. | Pass (Results shown in detail in the provided tables in the document, page 2 and 5-6). For Carmustine: 11.1 min (met its specific criterion). For Thio Tepa: 21.6 min (met its specific criterion). Fentanyl Citrate Injection: >240 min. |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | Non-sensitizing and Non-irritating | Non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity evaluated | Showed potential toxicity to L929 cells (concern addressed by acute systematic toxicity testing). |
| ISO 10993-11:2017 | Acute Systemic Toxicity Study | No adverse biological reaction | No evidence of systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for water leaks, chemical permeation). However, the tests were conducted according to established industry standards such as ASTM and ISO, which typically define appropriate sample sizes for such evaluations.
The data provenance is based on non-clinical laboratory testing performed by or for Better Care Plastic Technology Co., Ltd. The owner's identification indicates their address as "Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China," suggesting the tests took place in China. The data is retrospective in the sense that it represents completed laboratory tests submitted for the 510(k) application.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided in the document. For non-clinical validation of gloves, "ground truth" is typically established by adherence to established test methodologies (ASTM, ISO standards) and the measured physical/chemical properties, rather than expert consensus on subjective evaluations. The "experts" would be the certified laboratories and technicians performing these standardized tests.
4. Adjudication Method for the Test Set
Not applicable. As described above, the validation involves standardized physical and chemical property testing, not subjective human evaluation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance. This document pertains to physical medical devices (examination gloves), for which MRMC studies are not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This question is not applicable to a physical medical device like an examination glove. The "performance" being evaluated is the glove's physical and chemicalbarrier properties, not an algorithm's output.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on objective, quantitative measurements obtained through standardized laboratory test methods (e.g., ASTM D6319-19 for physical dimensions, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993 series for biocompatibility). These standards define the acceptable range or threshold for a given property.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product (nitrile gloves), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
July 27, 2022
Better Care Plastic Technology Co., Ltd. % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue, Chino, CA 91710, USA Chino, California 91710
Re: K221269
Trade/Device Name: Powder Free Nitrile Examination Gloves (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 Dated: April 18, 2022 Received: May 2, 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 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.
Bifeng Qian, M.D., Ph.D. 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) K221269
Device Name
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentany) Citrate
Indications for Use (Describe)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 11.1 |
| 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, 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 C, 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, 10mg/ml (10,000ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thio Tepa, 10mg/ml (10,000ppm) | 21.6 |
| Topotecan, 1mg/ml (1,000ppm) | >240 |
| Trisenox, 1mg/ml (1,000ppm) | >240 |
| Velcade, 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Please note that the following drugs have extremely low permeation times: |
{3}------------------------------------------------
| Carmustine: | 11.1 minutes |
|---|---|
| Thio Tepa: | 21.6 minutes |
*Warning: Do not use with Carmustine and Thio Tepa.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
The assigned 510(K) numbers: K221269 Date Prepared: July 22, 2022
1. Owner's Identification:
Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China Tel:86-311-66179668 Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel:909-590-1611 Email: kathyliu@hongrayusa.com or fdareg@hongray.com.cn
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: Exam Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Comfort Rubber Gloves Industries Sdn. Bhd. Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954)
4. Device Description:
Powder Free Nitrile Examination Gloves (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, 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). The gloves are single use, disposable, and provided non-sterile.
5. Indications for Use:
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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 and Fentanyl Citrate using ASTM D6978-05(2019)
{5}------------------------------------------------
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
The following chemicals have been tested with these gloves:
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) | in Minutes |
|---|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | |
| Busulfan 6mg/ml (6,000 ppm) | >240 | |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 11.1 | |
| 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, 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 C, 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, 10mg/ml (10,000ppm) | >240 | |
| Retrovir, 10mg/ml (10,000ppm) | >240 | |
| Rituximab, 10mg/ml (10,000ppm) | >240 | |
| Thio Tepa, 10mg/ml (10,000ppm) | 21.6 | |
| Topotecan, 1mg/ml (1,000ppm) | >240 | |
| Trisenox, 1mg/ml (1,000ppm) | >240 | |
| Velcade, 1mg/ml (1,000ppm) | >240 | |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
{6}------------------------------------------------
Fuqian Xi Road, West district of Shenze, Industrial Base,
Shenze County, Hebei, 050000, China
510K Summary
*Please note that the following drugs have extremely low permeation times: Carmustine: 11.1 minutes, Thio Tepa: 21.6 minutes Warning: Do not use with Carmustine and Thio Tepa.
6. Comparison of Subject Device and Predicate Device:
| General Comparison Table: | |||
|---|---|---|---|
| Proposed DeviceK221269 | Predicate DeviceK192954 | Comparison | |
| Trade Name | Powder Free NitrileExamination Gloves (Blue),Tested for Use withChemotherapy Drugs andFentanyl Citrate | Blue Colored, Power Free NitrileExamination Gloves Tested forUse with Chemotherapy Drugsand Fentanyl Citrate | Similar |
| Product Code | LZA, LZC, QDO | LZA, LZC,QDO | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | Powder Free NitrileExamination Gloves (Blue),Tested for Use withChemotherapy Drugs andFentanyl Citrate is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination between patientand examiner. Gloves havebeen tested for use withchemotherapy drugs andFentanyl Citrate using ASTMD6978 | Blue Colored, Powder Free NitrileExamination Gloves, Non-sterile,and Tested for Use withChemotherapy Drugs and FentanylCitrate is a patient medical examglove which is a disposable deviceintended for medical purpose thatis worn on the examiner's hand orfinger to prevent contaminationbetween examiner and patient.Glove was tested for use withChemotherapy Drugs and FentanylCitrate as per ASTM D6978 | Similar |
| Material | Nitrile | Nitrile | Same |
| Powder or Powder Free | Powder Free | Powder Free | Same |
| Color | Blue | Blue | Same |
| Single use | Single use | Single use | Same |
| Chemotherapy Drugsand Fentanyl CitrateClaim | See below comparison table | See below comparison table | See belowcomparisontable |
| Technological Characteristic Comparison Table: | |||
| TechnologicalCharacteristics | Proposed DeviceK221269 | Predicate DeviceK192954 | Comparison |
| Length | Minimum 230mm | Minimum 240mm | Similar |
| 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 | N/A | Different |
| Thickness(mm) | |||
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, BeforeAging | 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, AfterAccelerated Aging | 400%, min | 400%, min | Same |
| Watertight (1000ml) | 21 CFR 800.20ASTM D5151AQL 2.5 | 21 CFR 800.20ASTM D5151AQL 2.5 | Same |
| Powder-Content | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |
| 10993-10:2010 SkinIrritation Study | Under the conditions ofthe study, not an irritant | Under the conditions of thestudy, the subject device isnon-irritating | Same |
| 10993-10:2010 MaximizationSensitization Study | Under the conditions of thestudy, not a sensitizer | Under the conditions of thestudy, the subject device isnon sensitization | Same |
| 10993-5:2009 CytotoxicityTest | Under the conditions of thisstudy, the test article extractshowed potential toxicity toL929 cells.Cytotoxicity concern wasaddressed by acute systematictoxicity testing. | Exhibits severe cytotoxicityreactivity at 100%, and 66%extract concentrations andno cytotoxicity reactivity at44%, 30%, 20% and 15%extract concentrations underthe condition of this test.Cytotoxicity concern was | Same |
| addressed by acutesystematic toxicity testing. | |||
| ISO 10993-11:2017Acute Systemic toxicity study | Under the conditions of thisstudy, there was no evidenceof systemic toxicity. | Under the conditions of thestudy, the subject showed noadverse biological reaction. | Same |
{7}------------------------------------------------
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
Technological Characteristic Comparison Table:
{8}------------------------------------------------
Fuqian Xi Road, West district of Shenze, Industrial Base,
Shenze County, Hebei, 050000, China
510K Summary
Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drug andConcentration | Minimum BDT (Minutes) | Comparison | |
|---|---|---|---|
| Proposed DeviceK221269 | Predicate DeviceK192954 | ||
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | N/A | Different |
| Busulfan 6mg/ml (6,000 ppm) | >240 | N/A | Different |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | N/A | Different |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 11.1 | 18.2 | Similar |
| Chloroquine 50mg/ml (50,000ppm) | >240 | N/A | Different |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | Same |
| Cyclosporin 100 mg/ml (100,000 ppm) | >240 | N/A | Different |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | >240 | N/A | Different |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | Same |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | N/A | Different |
| Docetaxel , 10 mg/ml (10,000 ppm) | >240 | N/A | Different |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | N/A | Different |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | Same |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 | N/A | Different |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Gemcitabine, 38mg/ml (38,000ppm) | >240 | N/A | Different |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | N/A | Different |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | N/A | Different |
| Irinotecan, 20mg/ml (20,000ppm) | >240 | N/A | Different |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | N/A | Different |
| Melphalan, 5mg/ml (5,000ppm) | >240 | N/A | Different |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | N/A | Different |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | N/A | Different |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | N/A | Different |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 | N/A | Different |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | Same |
| Paraplatin, 10mg/ml (10,000ppm) | >240 | N/A | Different |
| Retrovir, 10mg/ml (10,000ppm) | >240 | N/A | Different |
{9}------------------------------------------------
Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
| Rituximab, 10mg/ml (10,000ppm) | >240 | N/A | Different |
|---|---|---|---|
| Thio Tepa, 10mg/ml (10,000ppm) | 21.6 | 57.3 | Similar |
| Topotecan, 1mg/ml (1,000ppm) | >240 | N/A | Different |
| Trisenox, 1mg/ml (1,000ppm) | >240 | N/A | Different |
| Velcade, 1mg/ml (1,000ppm) | >240 | N/A | Different |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | N/A | Different |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | Same |
7. Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical DimensionsLength | Minimum 230mm for allsizes | Pass |
| ASTM D6319- 19 | Physical DimensionsPalm Width | XS: 70±10mmS: 80±10mmM: 95±10mmL:110±10mmXL: 120±10mmXXL: 130±10mm | Pass |
| ASTM D6319- 19 | Physical DimensionsThickness | Finger: 0.05mm (min)Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14MPa) and Elongation(Before Aging 500% andafter aging 400%) MinAQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319- 19ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319- 19ASTM D6124-06(2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05(2019) | Permeation byChemotherapy Drugs | Refer the above table 1 | Pass |
| ISO 10993-10:2010 | Irritation and SkinSensitization | Skin sensitization andSkin irritation | Is non-sensitizationand Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | showed potentialtoxicity to L929cells. |
| ISO 10993-11:2017 | Acute systemic toxicitystudy | Subject showed no adversebiological reaction | no evidence ofsystemic toxicity. |
● ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
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Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China
510K Summary
- . ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- . ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
- . ASTM D412-16 (2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- . ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves to Permeation by Chemotherapy Drugs.
- 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
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.