(115 days)
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. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978 standards. Gloves is direct contact and not to be worn for more than 24 hours.
The subject device is Sterile Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs And Fentanyl Citrate (Blue). The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per 10993-11 and permeability to chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05(2019).
This document is a 510(k) premarket notification for "Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)". It details the device's characteristics, performance, and comparison to a predicate device.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is tested against various physical properties and chemical permeation criteria.
Physical Properties (based on ASTM D6319-19):
| Items | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Length | Minimum 230mm | All size ≥230 |
| Palm Width | XS: 70±10mm | 76-78mm |
| S: 80±10mm | 86-88 mm | |
| M: 95±10mm | 96-98mm | |
| L: 110±10mm | 106-108 mm | |
| XL: 120±10mm | 116-118 mm | |
| XXL: 130±10mm | 126-128 mm | |
| Thickness | Palm: 0.05mm (min) | 0.07-0.08mm |
| Finger: 0.05mm (min) | 0.09-0.11mm | |
| Tensile Strength, Before Aging | 14MPa, min | 15.7-20.6 MPa |
| Tensile Strength, After Accelerated Aging | 14MPa, min | 15.5-19.5 MPa |
| Ultimate Elongation, Before Aging | 500%, min | 500-550% |
| Ultimate Elongation, After Accelerated Aging | 400%, min | 410-510% |
| Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5 requirements |
| Powder-Content | ≤ 2 mg per glove | ≤ 2 mg, meet requirements |
Chemotherapy Drug and Fentanyl Citrate Permeation (based on ASTM D6978 standards):
| Chemotherapy Drug / Fentanyl Citrate Concentration | Reported Minimum Breakthrough Detection Time (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) | 22.4 |
| 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 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 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.3 |
| 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 |
Note: For Carmustine and Thiotepa, the document explicitly states warnings due to low permeation times, even though they have a reported BDT.
Biocompatibility Studies (ISO 10993-10, ISO 10993-11, ISO 10993-5):
| Technological Characteristics | Standard / Test / FDA Guidance | Result Summary (Acceptance Criteria & Performance) |
|---|---|---|
| Primary Skin Irritation Test | ISO 10993-10:2010 | Meets (Under the conditions of the study, not an irritant) |
| Dermal Sensitization Assay | ISO 10993-10:2010 | Meets (Under the conditions of the study, not a sensitizer) |
| In Vitro Cytotoxicity Test | ISO 10993-5:2009 | The test article extract showed potential toxicity to L929 cells. Cytotoxicity concern was addressed by acute systematic toxicity testing. |
| Acute Systemic Toxicity Test | ISO 10993-11:2017 | Meets (Under the conditions of this study, there was no evidence of systemic toxicity.) |
2. Sample size used for the test set and the data provenance
The document specifies the standards used for testing, which implicitly defines the sample sizes and testing methodologies. However, it does not explicitly state the exact sample sizes used for each specific test (e.g., number of gloves tested for each chemotherapy drug).
- Standards Used: ASTM D6319-19 (for dimensions, physical properties, freedom from holes, powder content) and ASTM D6978-05(2019) (for permeability to chemotherapy drugs and Fentanyl Citrate). Biocompatibility testing was done per ISO 10993-10, ISO 10993-11, and ISO 10993-5.
- Data Provenance: Not explicitly stated, but based on the owner's identification (Grand Work Plastic Products Co., Ltd. in Hebei, China) and the contact information (Hongray USA Medical Products Inc. in Chino, California), the testing was likely conducted by or for the manufacturer, potentially in China or a contracted lab. The data is retrospective for the purpose of this 510(k) submission, as the tests have already been performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the document describes the testing of physical and chemical properties of gloves against established industry standards. The "ground truth" here is the performance requirement defined by these standards, not expert consensus on medical images or clinical outcomes. The tests are objective measurements, not subjective expert interpretations.
4. Adjudication method for the test set
Not applicable. The tests performed are objective, quantitative measurements against predefined specifications (e.g., minimum length, minimum tensile strength, breakthrough detection time). There is no "adjudication" in the sense of reconciling differing expert opinions.
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 submission for sterile nitrile examination gloves, not an AI-powered diagnostic device. No human readers or AI assistance are involved in the performance evaluation of the gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (gloves), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is objective, laboratory-measured data based on established international standards:
- Physical properties (dimensions, strength, elongation, hole detection, powder content) are measured quantitatively according to ASTM D6319-19, ASTM D5151-19, and ASTM D6124-06(2017).
- Chemical permeation (breakthrough detection time for chemotherapy drugs and Fentanyl Citrate) is measured according to ASTM D6978-05(2019).
- Biocompatibility (skin irritation, sensitization, systemic toxicity, cytotoxicity) is assessed using in vitro and in vivo tests guided by ISO 10993 standards.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not a machine learning model.
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May 26, 2022
Grand Work Plastic Products Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K220249
Trade/Device Name: Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) 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: April 26, 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 Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220249
Device Name
Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
Indications for Use (Describe)
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. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978 standards.
Gloves is direct contact and not to be worn for more than 24 hours
| 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) | 22.4 |
| 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 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 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.3 |
| 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 |
{3}------------------------------------------------
- Please note that the following drugs have extremely low permeation times: Carmustine: 22.4 minutes, Thiotepa: 46.3 minutes WARNING: DO NOT USE WITH CARMUSTINE WARNING: DO NOT USE WITH THIOTEPA
| Fentanyl Citrate and Concentration |
|---|
| Fentanyl Citrate Injection (100 mcg/2ml) |
Minimum Breakthrough Detection Time in Minutes >240
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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Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.
The assigned 510(K) number is: K220249
Date Prepared: April 18, 2022
1. Owner's Identification:
Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: 86-311-66179668
Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611
2. Name of the Device:
Trade Name: Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LZA, LZC and QDO Device Class: Class I
3. Predicate Device Information:
Hartalega SDN.BHD. Sterile Nitrile Powder Free Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K201531)
4. Device Description:
The subject device is Sterile Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs And Fentanyl Citrate (Blue). The subject device is a patient examination glove made from nitrile latex compound, blue color, powder free and sterile (Per 21 CFR 880.6250, class I). The device is direct contact and not to be worn for more than 24 hours. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves.
Additionally, the gloves have been tested for biocompatibility per 10993-11 and permeability to chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05(2019).
5. Indications for Use:
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs & Fentany] Citrate and provides protection against following chemotherapy drugs and the minimum breakthrough time are listed as follows.
| 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 |
{5}------------------------------------------------
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
| Carmustine 3.3 mg/ml (3,300 ppm) | 22.4 |
|---|---|
| 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 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 |
| Thiotepa, 10mg/ml (10,000ppm) | 46.3 |
| 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: Carmustine: 22.4 minutes, Thiotepa: 46.3 minutes WARNING: DO NOT USE WITH CARMUSTINE WARNING: DO NOT USE WITH THIOTEPA
6. Specification for Nitrile Gloves:
| Items | Acceptance Criteria | Results |
|---|---|---|
| Length | Minimum 230mm | All size ≥230 |
| Palm Width | XS: 70±10mm | 76-78mm |
| S: 80±10mm | 86-88 mm | |
| M:95±10mm | 96 -98mm | |
| L:110±10mm | 106-108 mm | |
| XL: 120±10mm | 116-118 mm |
{6}------------------------------------------------
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
| XXL: $130\pm10$ mm | 126-128 mm | |
|---|---|---|
| Thickness | Palm: 0.05mm (min) | 0.07-0.08mm |
| Finger: 0.05mm (min) | 0.09-0.11mm | |
| Tensile Strength, Before Aging | 14MPa, min | 15.7-20.6 MPa |
| Tensile Strength, After Accelerated Aging | 14MPa, min | 15.5-19.5 MPa |
| Ultimate Elongation, Before Aging | 500%, min | 500-550% |
| Ultimate Elongation, After Accelerated Aging | 400%, min | 410-510% |
| Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5 requirements |
| Powder-Content | $\leq$ 2 mg per glove | $\leq$ 2 mg, meet requirements |
Gloves meet all the specification listed in ASTM D 6319-19.
7. Comparison of Subject Device and Predicate Device:
| Characteristics | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| K220249 | K201531 | ||
| Trade Name | Sterile Powder Free NitrileExamination Gloves (Blue), Testedfor Use with Chemotherapy Drugs | Nitrile Examination GlovesSterile Tested for Use withChemotherapy Drugs claim, White | Similar |
| Product Code | LZA, LZC and QDO | LZA, LZC and QDO | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | Subject device is a disposable deviceintended for medical purpose that isworn on the examiner's hand orfinger to prevent contaminationbetween patient and examiner. Thedevice is for over-the-counter use. | Predicate device is a disposable deviceintended for medical purpose that is wornon the examiner's hand or finger toprevent contamination between patient andexaminer. The device is for over-the-counter use. | Same |
| Description | Sterile Examination glove made ofNitrile and color Blue and testedwith chemotherapy Drugs | Sterile Examination glove made of Nitrileand color White and tested withchemotherapy Drugs | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Material use | Nitrile Synthetic Latex | Nitrile Synthetic Latex | Same |
| Color | Blue | Blue | Same |
| Sterility ISO 11737-2EN ISO 11137-2 | Sterility | Sterility | Same |
| Single used | Single used | Single used | Same |
| Non Sterile or Sterile | Sterile | Sterile | Same |
| 10993-10:2010 Skin IrritationStudy | Under the conditions of thestudy, not an irritant | Under the conditions of the study, notan irritant | Same |
| 10993-10:2010 MaximizationSensitization Study | Under the conditions of thestudy, not a sensitizer | Under the conditions of the study, not asensitizer | Same |
| 10993-5:2009 In Vitro | Under the conditions of this study, | Under the conditions of this study, the | Same |
{7}------------------------------------------------
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
| Cytotoxicity Test | the test article extract showed potential toxicity to L929 cells.Cytotoxicity concern was addressed by acute systematic toxicity testing. | test article extract showed potential toxicity to L929 cells.Cytotoxicity concern was addressed by acute systematic toxicity testing. | |
|---|---|---|---|
| ISO 10993 Part 11Acute Systemic Toxicity Test | Under the conditions of this study, there was no evidence of systemic toxicity. | Under the condition of this study, Nitrile Examination glove, sterile shows no adverse biological reaction | Same |
| TechnologicalCharacteristics | Subject DeviceK220249 | Predicate DeviceK201531 | Remark |
|---|---|---|---|
| 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 | / | Different |
| 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, AfterAccelerated Aging | 400%, min | 400%, min | Same |
| Freedom from holes | In accordance with ASTM D5151-19, following ASTMD6319- 19, G-I, AQL 2.5 | In accordance with ASTM D5151-19, following ASTMD6319- 19, G-I, AQL 2.5 | Same |
| Residual Powder | <2 mg per glove | <2 mg per glove | Same |
Dimensions and Performance Comparison Table:
Chemotherapy Permeation Comparison Claim:
| Tested Chemotherapy Drug andConcentration | Minimum BDT (Minutes) | Remark | |
|---|---|---|---|
| Predicate Device | Subject Device | ||
| Bleomycin Sulfate 15mg/ml (15000 ppm) | / | >240 | Different |
| Busulfan 6mg/ml (6,000 ppm) | / | >240 | Different |
| Carboplatin 10mg/ml (10,000 ppm) | / | >240 | Different |
| Carmustine 3.3 mg/ml (3,300 ppm) | 26.3 | 22.4 | Similar |
{8}------------------------------------------------
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
| Chloroquine 50mg/ml (50,000ppm) | / | >240 | 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 | Different |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | / | >240 | Different |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | Same |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | / | >240 | Different |
| Docetaxel HCL, 10 mg/ml (10,000 ppm) | / | >240 | Different |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | / | >240 | Different |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | Same |
| Fludarabine, 25 mg/ml (25,000 ppm) | / | >240 | Different |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Gemcitabine, 38mg/ml (38,000ppm) | / | >240 | Different |
| Idarubicin HCL, 1mg/ml (1,000ppm) | / | >240 | Different |
| Ifosfamide, 50mg/ml (50,000ppm) | / | >240 | Different |
| Irinotecan, 20mg/ml (20,000ppm) | / | >240 | Different |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | / | >240 | Different |
| Melphalan, 5mg/ml (5,000ppm) | / | >240 | Different |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | Same |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | >240 | Same |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | / | >240 | Different |
| Oxaliplatin, 5mg/ml (5,000ppm) | / | >240 | Different |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | Same |
| Paraplatin, 10mg/ml (10,000ppm) | / | >240 | Different |
| Retrovir, 10mg/ml (10,000ppm) | / | >240 | Different |
| Rituximab, 10mg/ml (10,000ppm) | / | >240 | Different |
| Thiotepa, 10mg/ml (10,000ppm) | 97.1 | 46.3 | Similar |
| Topotecan, 1mg/ml (1,000ppm) | / | >240 | Different |
| Trisenox, 1mg/ml (1,000ppm) | / | >240 | Different |
| Velcade, 1mg/ml (1,000ppm) | / | >240 | Different |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | >240 | Same |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | Same |
8 Summary of Non-Clinical Testing
Non-clinical tests were performed to verify that the subject device will meet the acceptance criteria of the performance test shown below:
| Technological Characteristics | Standard / Test /FDA Guidance | Result Summary |
|---|---|---|
| Dimensions | ASTM D6319-19 | Meets |
| Physical Properties | ASTM D6319-19 | Meets |
| Freedom from holes | ASTM D6319- 19ASTM D5151-19 | Meets |
| Residual Powder | ASTM D 6124-06(2017)ASTM D6319- 19 | Meets |
| Primary Skin Irritation Test | ISO 10993-10:2010 | Meets |
| Dermal Sensitization Assay | ISO 10993-10:2010 | Meets |
| Acute Systemic Toxicity | ISO 10993-11:2017 | Meets |
{9}------------------------------------------------
Donggao Industrial Zone, Zanhuang, Hebei, 050000, China
Product: Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
The subject device meets the applicable requirements for patient examination gloves with regards to dimension and sizes, physical properties, freedom from holes and powder Residuals as found in the following standards: ASTM D6139, ASTM D5151, ASTM D6124.The subject device passes biological reactivity testing for dermal sensitization, irritation and acute systemic toxicity with accordance ISO10993-10 and ISO 10993-11.
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the Subject device is as safe, as effective, and performs as well as or better than the legally marketed 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.