(155 days)
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.
Powder Free Nitrile Examination Gloves(Blue), Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Small, Medium, Large and Extra Large. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
The provided document describes the acceptance criteria and performance data for "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs." This is a Class I medical device, and the testing focuses on its physical properties, biocompatibility, and resistance to chemotherapy drug permeation. It is crucial to note that this document pertains to a physical medical device (gloves) and not an AI/Software as a Medical Device (SaMD). Therefore, questions related to AI/SaMD specific aspects like expert data labeling, MRMC studies, training set data, etc., are not applicable to this submission. The information provided aligns with typical performance testing for physical devices.
Here's the breakdown of the acceptance criteria and reported performance, tailored to the available information:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Length | Minimum 230mm | All size ≥230mm |
| ASTM D6319-19 | Palm Width | XS: 70 ± 10mmS: 80 ± 10mmM: 95 ± 10mmL: 110 ± 10mmXL: 120 ± 10mm | XS: 77-78mmS: 86-88 mmM: 96-98mmL: 108-110 mmXL: 116-117 mm |
| ASTM D6319-19 | Thickness | Finger: 0.05mm (min)Palm: 0.05mm (min) | ≥0.05mm |
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, Before Aging | 14MPa, min | ≥14 MPa |
| ASTM D6319-19, ASTM D412-16 | Tensile Strength, After Accelerated Aging | 14MPa, min | ≥14 MPa |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, Before Aging | 500%, min | ≥500% |
| ASTM D6319-19, ASTM D412-16 | Ultimate Elongation, After Accelerated Aging | 400%, min | ≥400% |
| ASTM D5151-19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5 requirements |
| ASTM D6124-06 (2017) | Powder-Content | ≤2 mg per glove | ≤2 mg, meet requirements |
| ISO 10993-10:2010 | Skin Irritation Study | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant |
| ISO 10993-10:2010 | Maximization Sensitization Study | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO 10993-5:2009 | Cytotoxicity Test | Under the conditions of this study, the test article extract showed potential toxicity | Under the conditions of this study, the test article extract showed potential toxicity |
| ISO 10993-11:2017 | Systemic toxicity | Under the conditions of this study, there was no evidence of systemic toxicity. | Under the conditions of this study, there was no evidence of systemic toxicity. |
| ASTM D6978-05 (2019) | Tested for Use with Chemotherapy Drugs (Minimum BDT) | No explicit numerical acceptance criteria for each drug are listed as "acceptance criteria" in the table. The table provides the reported values for the device. The "Acceptance Criteria" column for this test indicates "/", implying that the objective is to report the measured breakthrough times. Note: For Carmustine (BCNU) and Thio Tepa, the document explicitly states a warning due to "extremely low permeation times." | Bleomycin (15.0mg/ml): >240Bortezomib (Velcade) 1mg/ml: >240Busulfan (6.0mg/ml): >240Carboplatin, (10.0mg/ml): >240Carmustine(BCNU) (3.3 mg/ml): 7.0 minutesChloroquine, (50.0mg/ml): >240Cisplatin (1mg/ml): >240Cyclophosphamide (Cytoxan) (20mg/ml): >240Cyclosporin, (100.0mg/ml): >240Cytarabine, (100.0mg/ml): >240Dacarbazine (10mg/ml): >240Daunorubicin, HCL (5.0mg/ml): >240Docetaxel, (10.0mg/ml): >240Doxorubicin HCL (2mg/ml): >240Epirubicin HCL (Ellence), (2.0mg/ml): >240Etoposide (20mg/ml): >240Fludarabine, (25.0mg/ml): >240Fluorouracil (50mg/ml): >240Gemcitabine (38.0mg/ml): >240Idarubicin HCL (1.0mg/ml): >240Ifosfamide, (50.0mg/ml): >240Irinotecan, (20.0mg/ml): >240Mechlorethamine HCI, (1.0mg/ml): >240Melphalan, (5.0mg/ml): >240Methotrexate (25mg/ml): >240Mitomycin C, (0.5mg/ml): >240Mitoxantrone, (2.0mg/ml): >240Oxaliplatin, (5.0mg/ml): >240Paclitaxel (Taxol) (6mg/ml): >240Paraplatin, (10.0mg/ml): >240Retrovir, (10.0mg/ml): >240Rituximab, (10.0mg/ml): >240Thio Tepa (10mg/ml): 23.0 minutesTopotecan HCL, (1.0mg/ml): >240Trisonex, (1.0mg/ml): >240Vincristine, (1.0mg/ml): >240 |
Regarding the AI/SaMD specific questions, the following points are not applicable as this document describes performance testing for a physical medical glove.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the exact sample sizes for each physical test (e.g., how many gloves were tested for tensile strength, or how many samples for biocompatibility). Standard test methods (ASTM, ISO) typically define minimum sample sizes. The data provenance is implied to be from testing labs in relation to the manufacturer (Shanxi Hongjin Plastic Technology Co., Ltd. in China) and their US representative. This is a prospective testing of the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth for physical device performance is established by standardized laboratory testing methods (ASTM, ISO) rather than expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically relevant for human-in-the-loop assessments or expert consensus in image interpretation, not for physical material 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
- Not applicable. This is not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/SaMD. The "standalone" performance here refers to the physical properties of the glove itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The 'ground truth' for this device is based on objective measurements derived from standardized testing protocols (ASTM and ISO standards) measuring physical properties (like length, thickness, tensile strength, freedom from holes, powder content) and chemical resistance (breakthrough time for chemotherapy drugs), as well as biological responses (irritation, sensitization, cytotoxicity, systemic toxicity).
8. The sample size for the training set
- Not applicable. This is not an AI/SaMD, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no "training set" for physical device testing, there is no ground truth establishment method for it.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of non-clinical performance tests conducted in accordance with recognized international (ISO) and national (ASTM) standards. These tests assess the physical, chemical, and biological properties of the nitrile examination gloves.
The "Non-Clinical Performance Data" section (Page 9 of the document) explicitly lists the test methods used, their purpose, the acceptance criteria, and the results, confirming that the proposed device complies with these standards. For example, ASTM D6319-19 was used for dimensions and tensile properties, ASTM D5151-19 for freedom from holes, ASTM D6124-06 for powder content, and ASTM D6978-05 (Reapproved 2019) for chemotherapy drug permeation. Biocompatibility was assessed using ISO 10993 series standards (Parts 5, 10, and 11) for cytotoxicity, irritation, sensitization, and systemic toxicity.
The conclusion states, "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." This indicates that the results met the established benchmarks (which are often derived from the requirements of the standards themselves or comparison to a predicate device).
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Image /page/0/Picture/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2021
Shanxi Hongjin Plastic Technology Co., Ltd. Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K211604
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: July 23, 2021 Received: September 22, 2021
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.
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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 (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.
For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical And Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211604
Device Name
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
Powder Free Nittile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves:
| * Please note that the following drugs have extremely low permeation times: | |||
|---|---|---|---|
| Click Class of Children Carder Carder Carder | 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 |
| Chemotherapy Drug | Minimum BDT (Minutes |
|---|---|
| Bleomycin (15.0mg/ml) | >240 |
| Bortezomib (Velcade) 1mg/ml | >240 |
| Busulfan (6.0mg/ml) | >240 |
| Carboplatin, (10.0mg/ml) | >240 |
| Carmustine(BCNU) (3.3 mg/ml) | 7.0 |
| Chloroquine, (50.0mg/ml) | >240 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20mg/ml) | >240 |
| Cyclosporin, (100.0mg/ml) | >240 |
| Cytarabine, (100.0mg/ml) | >240 |
| Dacarbazine (10mg/ml) | >240 |
| Daunorubicin, HCL (5.0mg/ml) | >240 |
| Docetaxel, (10.0mg/ml) | >240 |
| Doxorubicin HCL (2mg/ml) | >240 |
| Epirubicin HCL (Ellence), (2.0mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fludarabine, (25.0mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Gemcitabine (38.0mg/ml) | >240 |
| Idarubicin HCL (1.0mg/ml) | >240 |
| Ifosfamide, (50.0mg/ml) | >240 |
| Irinotecan, (20.0mg/ml) | >240 |
| Mechlorethamine HCI, (1.0mg/ml) | >240 |
| Melphalan, (5.0mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Mitomycin C, (0.5mg/ml) | >240 |
| Mitoxantrone, (2.0mg/ml) | >240 |
| Oxaliplatin, (5.0mg/ml) | >240 |
| Paclitaxel (Taxol) (6mg/ml) | >240 |
| Paraplatin, (10.0mg/ml) | >240 |
| Retrovir, (10.0mg/ml) | >240 |
| Rituximab, (10.0mg/ml) | >240 |
| Thio Tepa (10mg/ml) | 23.0 |
| Topotecan HCL, (1.0mg/ml) | >240 |
| Trisonex, (1.0mg/ml) | >240 |
| Vincristine, (1.0mg/ml) | >240 |
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Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 7.0 minutes, Thio Tepa: 23 minutes, Warning: Do not use with Carmustine (BCNU) 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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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
510(K) SUMMARY
The assigned 510(K) numbers: K211604 Date Prepared: October 27, 2021
1. Owner's Identification:
Mr. Wu Zhigang Shanxi Hongjin Plastic Technology Co., Ltd. Coal Bed Gas Industrial Zone, Ou'e Town, Daning County, Linfen City, Shanxi Province
Tel: 86-311-66766067 Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel: 909-590-1611 Email: kathyliu@hongrayusa.com or fdareg@126.com
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs Common Name: Examination Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA LZC Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Better Care Plastic Technology Co., Ltd Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) (K182600)
4. Device Description:
Powder Free Nitrile Examination Gloves(Blue), Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes-Extra Small, Small, Medium, Large and Extra Large.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
510(K) SUMMARY
5. Indications for Use:
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05(2019) and will be labeled with a statement of compliance and a summary of the testing results. Chemotherapy Drug Permeation
| Chemotherapy Drug | Minimum BDT (Minutes) |
|---|---|
| Bleomycin (15.0mg/ml) | >240 |
| Bortezomib (Velcade) 1mg/ml | >240 |
| Busulfan (6.0mg/ml) | >240 |
| Carboplatin, (10.0mg/ml) | >240 |
| Carmustine(BCNU) (3.3 mg/ml) | 7.0 |
| Chloroquine, (50.0mg/ml) | >240 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20mg/ml) | >240 |
| Cyclosporin, (100.0mg/ml) | >240 |
| Cytarabine, (100.0mg/ml) | >240 |
| Dacarbazine (10mg/ml) | >240 |
| Daunorubicin, HCL (5.0mg/ml) | >240 |
| Docetaxel, (10.0mg/ml) | >240 |
| Doxorubicin HCL (2mg/ml) | >240 |
| Epirubicin HCL (Ellence), (2.0mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fludarabine, (25.0mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Gemcitabine (38.0mg/ml) | >240 |
| Idarubicin HCL (1.0mg/ml) | >240 |
| Ifosfamide, (50.0mg/ml) | >240 |
| Irinotecan, (20.0mg/ml) | >240 |
| Mechlorethamine HCI, (1.0mg/ml) | >240 |
| Melphalan, (5.0mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Mitomycin C, (0.5mg/ml) | >240 |
| Mitoxantrone, (2.0mg/ml) | >240 |
| Oxaliplatin, (5.0mg/ml) | >240 |
| Paclitaxel (Taxol) (6mg/ml) | >240 |
| Paraplatin, (10.0mg/ml) | >240 |
| Retrovir, (10.0mg/ml) | >240 |
| Rituximab, (10.0mg/ml) | >240 |
The following chemicals have been tested with these gloves:
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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
510(K) SUMMARY
| Thio Tepa (10mg/ml) | 23.0 |
|---|---|
| Topotecan HCL, (1.0mg/ml) | >240 |
| Trisonex, (1.0mg/ml) | >240 |
| Vincristine, (1.0mg/ml) | >240 |
- Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 7.0 minutes, Thio Tepa: 23 minutes
6. Comparison of Subject Device and Predicate Device:
The proposed device will be known as Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs.
The following tables are summaries of the technological characteristics, biocompatibility and testing for use with chemotherapy drugs of the proposed and predicate devices.
| Proposed Device K211604 | Predicate Device K182600 | Remark | |
|---|---|---|---|
| Trade Name | Powder Free NitrileExamination Gloves(Blue), Tested for Usewith ChemotherapyDrugs | Powder Free NitrileExamination Gloves,Tested for Use withChemotherapy Drugs(Blue) | Same |
| Product Code | LZA, LZC | LZA, LZC | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | Powder Free NitrileExamination Gloves (Blue),Tested for Use withChemotherapy Drugs is adisposable device intended formedical purposes that is wornon the examiner's hand toprevent contaminationbetween patient and examiner. | Powder Free NitrileExamination Gloves, Tested forUse with Chemotherapy Drugs(Blue) is a disposable deviceintended for medical purposesthat is worn on the examiner'shand to prevent contaminationbetween patient and examiner. | Same |
| Powder or PowderFree | Powder Free | Powder Free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Blue | Blue | Similar |
| LabelingInformation | Single-use, powder freeglove size, quantity,Nitrile ExaminationGloves, Non Sterile | Single-use, powder free glovesize, quantity, NitrileExamination Gloves, NonSterile | Same |
| 510(K) SUMMARYChemotherapy Drug | See below comparison | ||
| Permeation Claim | table | See below comparison table | Same |
| Dimensions and Performance Comparison Table: | |||
| Technological | Proposed Device | Predicate Device | |
| Characteristics | K211604 | K182600 | 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 |
| Thickness(mm) | |||
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, | |||
| Before Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, | |||
| Before Aging | 500%, min | 500%, min | Same |
| Tensile Strength, After | |||
| Accelerated Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, | |||
| After Accelerated | 400%, min | 400%, min | Same |
| Aging | |||
| In accordance with ASTM D | In accordance with ASTM D | ||
| Freedom from holes | 5151-19, following ASTM | 5151-19, following ASTM | Same |
| D6319- 19, G-I, AQL 2.5 | D6319- 19, G-I, AQL 2.5 | ||
| Powder-Content | < 2 mg per glove | < 2 mg per glove | Similar |
| 10993-10:2010 Skin | Under the conditions of the | Under the conditions of the | |
| Irritation Study | study, | study, | Same |
| not an irritant | not an irritant | ||
| 10993-10:2010 | Under the conditions of the | Under the conditions of the | |
| Maximization | study,not a sensitizer | study,not a sensitizer | Same |
| Sensitization Study | |||
| 10993-5:2009 | Under the conditions of this | Under the conditions of | |
| Cytotoxicity Test | study, the test article extract | this study, no cytotoxic | Same |
| showed potential toxicity | potential | ||
| ISO 10993 Part 11 | Under the conditions of this | / | / |
| Systemic toxicity | study, there was no evidence ofsystemic toxicity. | ||
| Tested Chemotherapy Drug andConcentration | Minimum BDT (Minutes) | Remark | |
| Proposed DeviceK211604 | Predicate DeviceK182600 | ||
| Bleomycin (15.0mg/ml) | >240 | >240 | Same |
| Bortezomib (Velcade) 1mg/ml | >240 | >240 | Same |
| Busulfan (6.0mg/ml) | >240 | >240 | Same |
| Carboplatin, (10.0mg/ml) | >240 | >240 | Same |
| Carmustine(BCNU) (3.3 mg/ml) | 7.0 | 11.0 | similar |
| Chloroquine, (50.0mg/ml) | >240 | >240 | Same |
| Cisplatin (1mg/ml) | >240 | >240 | Same |
| Cyclophosphamide (Cytoxan) (20mg/ml) | >240 | >240 | Same |
| Cyclosporin, (100.0mg/ml) | >240 | >240 | Same |
| Cytarabine, (100.0mg/ml) | >240 | >240 | Same |
| Dacarbazine (10mg/ml) | >240 | >240 | Same |
| Daunorubicin, HCL (5.0mg/ml) | >240 | >240 | Same |
| Docetaxel, (10.0mg/ml) | >240 | >240 | Same |
| Doxorubicin HCL (2mg/ml) | >240 | >240 | Same |
| Epirubicin HCL (Ellence), (2.0mg/ml) | >240 | >240 | Same |
| Etoposide (20mg/ml) | >240 | >240 | Same |
| Fludarabine, (25.0mg/ml) | >240 | >240 | Same |
| Fluorouracil (50mg/ml) | >240 | >240 | Same |
| Gemcitabine (38.0mg/ml) | >240 | >240 | Same |
| Idarubicin HCL (1.0mg/ml) | >240 | >240 | Same |
| Ifosfamide, (50.0mg/ml) | >240 | >240 | Same |
| Irinotecan, (20.0mg/ml) | >240 | >240 | Same |
| Mechlorethamine HCI, (1.0mg/ml) | >240 | >240 | Same |
| Melphalan, (5.0mg/ml) | >240 | >240 | Same |
| Methotrexate (25mg/ml) | >240 | >240 | Same |
| Mitomycin C, (0.5mg/ml) | >240 | >240 | Same |
| Mitoxantrone, (2.0mg/ml) | >240 | >240 | Same |
| Oxaliplatin, (5.0mg/ml) | >240 | >240 | Same |
| Paclitaxel (Taxol) (6mg/ml) | >240 | >240 | Same |
| Paraplatin, (10.0mg/ml) | >240 | >240 | Same |
| Retrovir, (10.0mg/ml) | >240 | >240 | Same |
| Rituximab, (10.0mg/ml) | >240 | >240 | Same |
| Thio Tepa (10mg/ml) | 23.0 | 28.8 | similar |
| Topotecan HCL, (1.0mg/ml) | >240 | >240 | Same |
| Trisonex, (1.0mg/ml) | >240 | >240 | Same |
| Vincristine, (1.0mg/ml) | >240 | >240 | Same |
General Comparison Table:
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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County,
Chemotherapy Permeation Comparison Claim:
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Coal Bed Gas Ino Industrial Zone, Qu'e Town, Daning County,
510(K) SUMMARY
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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
510(K) SUMMARY 7. Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests For ● Irritation And Skin Sensitization.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In Vitro . Cytotoxicity
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for ● systemic toxicity
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on ● Medical Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ●
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves ● to Permeation by Chemotherapy Drugs.
| Test method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Length | Minimum 230mm | All size ≥230 |
| ASTM D6319- 19 | Palm Width | XS: 70 $\pm$ 10mm | 77-78mm |
| S: 80 $\pm$ 10mm | 86-88 mm | ||
| M:95 $\pm$ 10mm | 96 -98mm | ||
| L:110 $\pm$ 10mm | 108-110 mm | ||
| XL: 120 $\pm$ 10mm | 116-117 mm | ||
| ASTM D6319- 19 | Thickness | Finger: 0.05mm (min)Palm: 0.05mm (min) | ≥0.05mm |
| ASTM D6319-19ASTN D412-16 | Tensile Strength, BeforeAging | 14MPa, min | ≥14 MPa |
| ASTM D6319-19ASTN D412-16 | Tensile Strength, AfterAccelerated Aging | 14MPa, min | ≥14 MPa |
| ASTM D6319-19ASTN D412-16 | Ultimate Elongation,Before Aging | 500%, min | ≥500% |
| ASTM D6319-19ASTN D412-16 | Ultimate Elongation,After Accelerated Aging | 400%, min | ≥400% |
| ASTM D 5151-19 | Freedom from holes | G-I, AQL 2.5 | Meet and above AQL2.5requirements |
| ASTM D 6124-06(2017) | Powder-Content | ≤2 mg per glove | ≤2 mg, meet requirements |
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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
| ISO 10993-10:2010 | Skin Irritation Study | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant |
|---|---|---|---|
| ISO 10993-10:2010 | MaximizationSensitization Study | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO 10993-5:2009 | Cytotoxicity Test | Under the conditions of this study, the test article extract showed potential toxicity | Under the conditions of this study, the test article extract showed potential toxicity |
| ISO 10993-11:2017 | Systemic toxicity | Under the conditions of this study, there was no evidence of systemic toxicity. | Under the conditions of this study, there was no evidence of systemic toxicity. |
| ASTM D6978-05 (2019) | Tested for Use withChemotherapy Drugs | / | Details refer to the above 5.0 result |
510(K) SUMMARY
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.