(82 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)
Aloe Vera Nitrile Examination Gloves (Green) 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, 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.
The provided document describes the acceptance criteria and study results for the "Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K240080).
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the gloves are based on various physical characteristics, chemical permeation resistance (as per ASTM D6978-05(2019)), and biocompatibility tests (as per ISO 10993 standards). The reported device performance is compared to these criteria and, in some cases, to a predicate device (K200671).
Physical and Design Characteristics (Meeting ASTM D6319-19):
| Characteristic | Acceptance Criteria (Subject Device K240080) | Reported Device Performance (Subject Device K240080) |
|---|---|---|
| Length (Minimum) | XS: ≥ 220 mm, S: ≥ 220 mm, M: ≥ 230 mm, L: ≥ 230 mm, XL: ≥ 230 mm, XXL: ≥ 230 mm | Meets ASTM D6319-19 requirements |
| Palm Width (mm) | XS: 70±10, S: 80±10, M: 95±10, L: 110±10, XL: 120±10, XXL: 130±10 | Meets ASTM D6319-19 requirements |
| Thickness (mm) (Minimum) | Finger: 0.05, Palm: 0.05 | Meets ASTM D6319-19 requirements |
| Tensile Strength, Before Aging, min | 14 MPa | 14 MPa |
| Ultimate Elongation, Before Aging, min | 500% | 500% |
| Tensile Strength, After Accelerated Aging, min | 14 MPa | 14 MPa |
| Ultimate Elongation, After Accelerated Aging, min | 400% | 400% |
| Freedom from holes | G-I, AQL 2.5 | G-I, AQL 2.5 |
| Powder residual | ≤ 2 mg per glove | ≤ 2 mg per glove |
Chemotherapy Permeation Resistance (ASTM D6978-05(2019)):
| Chemotherapy Drug | Acceptance Criteria (Minimum Permeation Time from Predicate or Acceptable Performance) | Reported Device Performance (Minimum BDT in Minutes for K240080) |
|---|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | Similar to predicate (23.4 minutes) | 21.2 |
| Cisplatin, 1mg/ml (1000 ppm) | N/A (predicate did not test this) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 |
| Dacarbazine, 10 mg/ml (10,000 ppm) | N/A (predicate did not test this) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 |
| Fluorouracil (5 Flu), 50mg/ml (50,000ppm) | >240 | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 |
| Mitomycin C, 0.5mg/ml (500 ppm) | N/A (predicate did not test this) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | Similar to predicate (64.9 minutes) | 24.9 |
| Vincristine sulfate, 1mg/ml (1000 ppm) | >240 | >240 |
Fentanyl Citrate Permeation Resistance (ASTM D6978-05(2019)):
| Fentanyl Citrate | Acceptance Criteria (Minimum Permeation Time) | Reported Device Performance (Minimum BDT in Minutes for K240080) |
|---|---|---|
| Fentanyl Citrate Injection, 100mcg/2mg | >240 | >240 |
Biocompatibility (ISO 10993 Standards):
| Test | Acceptance Criteria | Reported Device Performance (K240080) |
|---|---|---|
| In vitro Cytotoxicity ISO 10993-5 | Absence of cytotoxicity or similar to predicate (cytotoxic at certain dilutions, non-cytotoxic at others) | Showed potential toxicity to L929 cells (similar to predicate which was cytotoxic at higher concentrations). |
| Acute Systemic Toxicity Test ISO 10993-11 | No evidence of acute systemic toxicity | No evidence of acute systemic toxicity. |
| Dermal Sensitization ISO 10993-10 | No evidence of causing skin sensitization | No evidence of causing skin sensitization. |
| Primary Skin Irritation ISO 10993-23 | Negligible response/not an irritant | Response categorized as negligible under the test condition. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each test. However, it indicates that tests were conducted according to recognized international standards such as ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6978-05(2019) (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs), and ISO 10993 series for biocompatibility. These standards typically specify the number of samples required for testing.
The data provenance is not explicitly stated as 'country of origin' in that format, but the applicant is "Syntex Healthcare Products Co., Ltd" from "Xinji, Hebei, China," indicating the testing likely occurred under their purview or by contracted labs. The studies appear to be prospective testing conducted specifically for this premarket notification.
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)
This information is not applicable as the document describes performance testing of a physical medical device (gloves) against established engineering and biocompatibility standards. It does not involve interpretation of medical images or patient data by human experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as point 3. Testing involves objective measurements against predefined standards.
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 device is a medical glove, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on established international and national standards for medical gloves:
- ASTM D6319-19: for physical dimensions and integrity (e.g., freedom from holes, tensile strength).
- ASTM D6978-05(2019): for resistance to permeation by chemotherapy drugs and Fentanyl Citrate, where "breakthrough detection time" is the key metric.
- ISO 10993 series (ISO 10993-5, -10, -11, -23): for biocompatibility assessments like cytotoxicity, sensitization, irritation, and systemic toxicity.
8. The sample size for the training set
This information is not applicable as the device is a physical product and does not involve machine learning or AI models with training sets.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical product and does not involve machine learning or AI models.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
April 2, 2024
Syntex Healthcare Products Co., Ltd. Zhiqiang Qiao General Manager No. 1, Fanjiazhuang Industrial Zone Xinji, Hebei 052360 China
Re: K240080
Trade/Device Name: Aloe Vera Nitrile Examination Gloves (Green) 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, OPJ Dated: January 10, 2024 Received: January 11, 2024
Dear Zhiqiang Oiao:
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/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.
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"
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(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 OS 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
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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) K240080
Device Name
Aloe Vera Nitrile Examination Gloves (Green) 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 Fentany] Citrate using ASTM D6978-05(2019) The following chemicals have been tested with these gloves:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 21.2 |
| Cisplatin, 1mg/ml (1000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil (5 Flu), 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500 ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 24.9 |
| Vincristine sulfate, 1mg/ml (1000 ppm) | >240 |
| Fentanyl Citrate | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 21.2 minutes, Thio Tepa: 24.9minutes
Warning: Do not use with Carmustine and Thiotepa.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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The assigned 510(K) numbers: K240080
Date Prepared: March 14, 2024
1. Owner's Identification:
Syntex Healthcare Products Co., Ltd No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China Contact: Mr. Qiao Zhiqiang / General Manager Tel:86-311-66179668 Email: fdareg@hongray.com.cn or janicema(@hongrayusa.com
2. Device Identification:
Trade / Product Name: Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Exam Gloves Classification Name: Non-powdered patient examination glove Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, ODO, OPJ Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Ansell Healthcare Products LLC. Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K200671) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. Product Code: LZA, LZC, QDO
4. Device Description:
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentary) Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
5. Indications for Use:
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) The following chemicals have been tested with these gloves:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 21.2 |
| Cisplatin, 1mg/ml (1000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine, 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
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| Fluorouracil (5 Flu), 50mg/ml (50,000ppm) | >240 |
|---|---|
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500 ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 24.9 |
| Vincristine sulfate, 1mg/ml (1000 ppm) | >240 |
| Fentanyl Citrate | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
*Please note that the following drugs have extremely low permeation times:
Carmustine: 21.2 minutes, Thiotepa: 24.9 minutes
Warning: Do not use with Carmustine and Thiotepa.
6. Comparison of Subject Device and Predicate Device:
The following tables are summaries of the technological characteristics, biocompatibility and testing for use with chemotherapy drugs & Fentanyl Citrate of the subject and predicate devices. General Comparison Table:
| Characteristics andParameters | Subject DeviceK240080 | Predicate DeviceK200671 | ComparisonResult |
|---|---|---|---|
| Trade Name | Aloe Vera Nitrile Examination Gloves(Green) Tested for Use withChemotherapy Drugs and FentanylCitrate | Microflex® Nitrile PatientExamination Gloves with Aloe andChamomile Pink Colored Tested forUse with Chemotherapy Drugs andFentanyl Citrate | Different* |
| Product Code | LZA, LZC, QDO,OPJ | LZA, LZC,QDO | Different** |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | The glove is a disposable deviceintended for medical purposes that isworn on the examiner's hand toprevent contamination betweenpatient and examiner.Gloves have been tested for use withchemotherapy drugs and FentanylCitrate using ASTM D6978-05(2019) | The glove is a disposable deviceintended for medical purposes that isworn on the examiner's hand toprevent contamination betweenpatient and examiner.The gloves have been tested for use withchemotherapy drugs and FentanylCitrate using ASTM D6978-05(2019) | Same |
| Material | Synthetic nitrile rubber | Synthetic nitrile rubber | Same |
| Color | Green | Pink | Different*** |
| Design | • Single Use• Non-sterile• Powder-Free• Ambidextrous• Beaded cuff | • Single Use• Non-sterile• Powder-Free• Ambidextrous• Beaded cuff | Same |
| Chemotherapy Drugsand Fentanyl CitrateClaim | See below comparison table | See below comparison table | / |
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| Aloe | Aloe coated on the donning surface | Aloe and Chamomile coated on the donning surface | Same |
|---|---|---|---|
| ------ | ------------------------------------ | -------------------------------------------------- | ------ |
- The trade name will be provided on the labeling, so the different does not raise any safety concerns.
** QDO and OPJ, both designated for Medical Gloves with Fentanyl Labeling Claims - Test For Use With Fentanyl, the subject device added the product code OPJ as per requirements but does not raise questions of safety and effectiveness.
*** The finished subject device has been tested with performance and Biocompatibility, all the test results meet the requirements, so the difference of color does not raise questions of safety and effectiveness.
Technological Characteristic Comparison Table:
| Technological Characteristics | Subject DeviceK240080 | Predicate DeviceK200671 | ComparisonResult |
|---|---|---|---|
| Length | MinimumXS: ≥ 220 mmS: ≥ 220 mmM: ≥ 230 mmL: ≥ 230 mmXL: ≥ 230 mmXXL: ≥ 230 mm | MinimumXS: ≥ 220 mmS: ≥ 220 mmM: ≥ 230 mmL: ≥ 230 mmXL: ≥ 230 mm | 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 | / | Different* |
| Thickness (mm) (Minimum) | |||
| Finger | 0.05 | 0.05 | Same |
| Palm | 0.05 | 0.05 | Same |
| Tensile Strength, Before Aging,min | 14MPa | 16MPa | Similar* |
| Ultimate Elongation,Before Aging, min | 500% | 500% | Same |
| Tensile Strength, AfterAccelerated Aging, min | 14MPa | 14MPa | Same |
| Ultimate Elongation, AfterAccelerated Aging, min | 400% | 400% | Same |
| Freedom from holes | Meet ASTMD6319 andsimilar | ||
| G-I, AQL 2.5 | G-I, AQL 2.5 | ||
| Powder residual | Residual Powder: ≤ 2 mg perglove | Residual Powder: ≤ 2 mg perglove | Same |
| In vitro CytotoxicityISO 10993-5 | Under the conditions of this study,the test article showed potentialtoxicity to L929 cells. | Under the conditions of thestudy, undiluted, 1:2, 1:4, 1:8,1:16 dilution was cytotoxic., 1:32and 1:64 are not cytotoxic | Same |
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| Acute Systemic Toxicity TestISO 10993-11 | Under the conditions of this study, there was no evidence of acute systemic toxicity from the test article. | Under the conditions of the study, no evidence of acute systemic toxicity | Same |
|---|---|---|---|
| Dermal SensitizationISO 10993-10 | Under the conditions of this study, the test article showed no evidence of causing skin sensitization | Under the conditions of the study, not a sensitizer | Same |
| Primary Skin IrritationISO 10993-23 | The test result showed that the response of the test article was categorized as negligible under the test condition. | Under the conditions of the study, not an irritant | Same |
*The subject device has Size XXL and the predicate device has not size XXL, but the subject device has been tested according to ASTM D6319-19 for dimensions meet the requirements of ASTM D6319-19. It can demonstrate the effectiveness of the subject device.
Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drug and Concentration | Minimum BDT (Minutes) | ComparisonResult | |
|---|---|---|---|
| Subject DeviceK240080 | Predicate DeviceK200671 | ||
| Carmustine 3.3 mg/ml (3,300 ppm) | 21.2 | 23.4 | Similar * |
| Cisplatin, 1mg/ml (1000 ppm) | >240 | / | Different* |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | Same |
| Dacarbazine, 10 mg/ml (10,000 ppm) | >240 | / | Different* |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | Same |
| Fluorouracil (5 Flu), 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | Same |
| Mitomycin C, 0.5mg/ml (500 ppm) | >240 | / | Different* |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 24.9 | 64.9 | Similar* |
| Vincristine sulfate, 1mg/ml (1000 ppm) | >240 | >240 | Same |
| Minimum BDT (Minutes) | |||
| Fentanyl Citrate | Subject DeviceK240080 | Predicate DeviceK200671 | ComparisonResult |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | Same |
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this difference and similar does not raise questions of safety and effectiveness of subject device.
7. Clinical Performance Data
Not applicable.
8. Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate 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.