(277 days)
Not Found
No
The device is a disposable examination glove, and the description focuses on material properties, barrier protection, and testing against standards like ASTM D6319-10 and ASTM D6978-05. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a patient examination glove, which is intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: This device is a patient examination glove, intended to provide barrier protection, not to diagnose a condition or disease.
No
The device is a physical examination glove made of nitrile, which is a hardware component. The description focuses on material properties and physical performance testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between the patient and examiner by being worn on the hand or fingers. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description focuses on the material (nitrile), form (glove), and physical properties (barrier protection, tensile strength, water leak). It does not describe any components or processes related to analyzing samples from the body for diagnostic purposes.
- Performance Studies: The performance studies listed are all bench tests evaluating the physical properties and barrier function of the glove (dimensions, tensile strength, water leak, powder residual, biocompatibility, chemotherapy drug permeation). These are not studies related to diagnostic accuracy or performance.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
The device is clearly described as a patient examination glove, which falls under the category of medical devices used for barrier protection during examinations.
N/A
Intended Use / Indications for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs is a patient examination glove made from nitrile compound. non-sterile (as per 21 CFR 880.6250. Class I). The patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. Central Medicare Blue Non Sterile Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs made by Central Medicare Sdn. Bhd. met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing:
- A Dimension per ASTM D6319-10 (Reapproved 2015)
-
Tensile strength (Before aging/After aging) and Elongation (Before aging/After aging) per ASTM D6319-10(Reapproved 2015)
-
Water leak test on pinhole per ASTM D6319-10(Reapproved 2015) and per 21 CFR 800.20.
- A Powder Residual tests per ASTM D6319-10(Reapproved 2015)
- A Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01.
-
Assessment Of Resistance To Permeation By Chemotherapy Drugs per ASTM D6978-05(R 2013)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Carmustine (BCNU) 3.3 mg/ml: Minimum Breakthrough Detection Time 59.4 minutes.
Thiotepa 10.0 mg/ml: Minimum Breakthrough Detection Time 118.5 minutes.
All other listed chemotherapy drugs (34 of them): Minimum Breakthrough Detection Time > 240 minutes.
Also:
Tensile strength (Before aging) ≥14MPa
Tensile strength (After aging) ≥14MPa
Elongated rate (Before aging) ≥500%
Elongated rate (After aging) ≥400%
Powder Residual
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 23, 2019
Ever Growth (Vietnam) Co. Ltd. % Elizabeth Deng U.S. Representative Elizabeth Deng 5748 Eaglewood Place Ranch Cucamonga, California 91730
Re: K190736
Trade/Device Name: Disposable Powder Free Nitrile Examination Glove, Blue Color, 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: April 2, 2019 Received: September 30, 2019
Dear Elizabeth Deng:
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.
Elizabeth Claverie, M.S. 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
2
Indications for Use
510(k) Number (if known) K190736
Device Name
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
| Test Chemotherapy Drug | Concentration(mg/ml) | Minimum Breakthrough Detection Time ( Min ) |
|---|---|---|
| 01 Bleomycin Sulfate | 15.0 | > 240 |
| 02 Busulfan | 6.0 | > 240 |
| 03 Carboplatin | 10.0 | > 240 |
| 04 Carmustine (BCNU) | 3.3 | 59.4 |
| 05 Chloroquine | 50.0 | > 240 |
| 06 Cisplatin | 1.0 | > 240 |
| 07 Cyclophosphamide | 20.0 | > 240 |
| 08 Cyclosporin A | 100.0 | > 240 |
| 09 Cytarabine | 100.0 | > 240 |
| 10 Dacarbazine (DTIC) | 10.0 | > 240 |
| 11 Daunorubicin | 5.0 | > 240 |
| 12 Docetaxel | 10.0 | > 240 |
| 13 Doxorubicin Hydrochloride | 2.0 | > 240 |
| 14 Epirubicin | 2.0 | > 240 |
| 15 Etoposide (Toposar) | 20.0 | > 240 |
| 16 Fludarabine | 25.0 | > 240 |
| 17 Fluorouracil | 50.0 | > 240 |
| 18 Gemcitabine | 38.0 | > 240 |
| 19 Idaribicin | 1.0 | > 240 |
| 20 Ifosfamide | 50.0 | > 240 |
| 21 Irinotecan | 20.0 | > 240 |
| 22 Mechlorethamine HCl | 1.0 | > 240 |
| 23 Melphalan | 5.0 | > 240 |
| 24 Methotrexate | 25.0 | > 240 |
| 25 Mitomycin C | 0.5 | > 240 |
| 26 Mitoxantrone | 2.0 | > 240 |
| 27 Oxaliplatin | 2.0 | > 240 |
| 28 Paclitaxel (Taxol) | 6.0 | > 240 |
| 29 Paraplatin | 10.0 | > 240 |
| 30 Retrovir | 10.0 | > 240 |
| 31 Rituximab | 10.0 | > 240 |
| 32 Thiotepa | 10.0 | 118.5 |
| 33 Topotecan HCl | 1.0 | > 240 |
| 34 Trisonex | 1.0 | > 240 |
| 35 Velcade (Bortezomib) | 1.0 | > 240 |
| 36 Vincristine | 1.0 | > 240 |
3
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:
| Carmustine (BCNU) | 3.3 mg/ml | 59.4 minutes |
|---|---|---|
| Thiotepa | 10.0 mg/ml | 118.5 minutes |
Type of Use (Select one or both, as applicable)
__ Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
K190736
1.0 Submitter:
| Submitter's name : | Ever Growth (Vietnam) Co., Ltd. |
|---|---|
| Submitter's address : | Long Khanh Industrial Zone, Binh Loc Ward, Long Khanh Township, Dong Nai, Vietnam |
| Phone number : | 84-61-3514025 |
| Fax number : | 84-61-3514023 |
| Name of contact person: | Ming Lee |
| Summary Preparation Date: | Nov. 26th, 2019 |
2.0 US Agent:
| US representative name | Elizabeth Deng |
|---|---|
| Company address | 5748 Eaglewood Place, Rancho Cuamonga, California, Rancho Cucamonga, CA 91739 |
| Telephone number | 909 4659188 |
| Contact email | Baxianunited48@Yahoo.Com |
3.0 Name of the Device
| Proprietary/Trade name: | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs |
|---|---|
| Common Name: | Nitrile Examination Gloves |
| 510(k) Number | K190736 |
| Classification Name: | Patient Examination Glove |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 880.6250 |
| Product Code: | LZA, LZC |
4.0 Predicate device
| Device Name: | Central Medicare Blue Non Sterile Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs |
|---|---|
| Company name: | Central Medicare Sdn. Bhd |
| 510(K) Number: | K173942 |
5.0 Device Description:
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs is a patient examination glove made from nitrile compound. non-sterile (as per 21 CFR 880.6250. Class I). The
patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
6.0 Indications for Use:
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min.) | |
|---|---|---|
| 1 | Bleomycin Sulfate 15.0 mg/ml | > 240 |
| 2 | Busulfan 6.0 mg/ml | > 240 |
| 3 | Carboplatin 10.0 mg/ml | > 240 |
| Table 5.1 Nitrile Blue color test for 36 chemotherapy drugs | |||
|---|---|---|---|
| ------------------------------------------------------------- | -- | -- | -- |
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs
5
| 4 | Carmustine (BCNU), 3.3 mg/ml | 59.4 |
|---|---|---|
| 5 | Chloroquine 50.0 mg/ml | > 240 |
| 6 | Cisplatin 1 mg/ml | > 240 |
| 7 | Cyclophosphamide 20 mg/ml | > 240 |
| 8 | Cyclosporin A 100.0 mg/ml | > 240 |
| 9 | Cytarabine 100.0 mg/ml | > 240 |
| 10 | Dacarbazine (DTIC), 10.0 mg/ml | > 240 |
| 11 | Daunorubicin 5.0 mg/ml | > 240 |
| 12 | Docetaxel 10.0 mg/ml | > 240 |
| 13 | Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 |
| 14 | Epirubicin 2.0 mg/ml | > 240 |
| 15 | Etoposide (Toposar), 20.0 mg/ml | > 240 |
| 1 | Fludarabine 25.0 mg/ml | > 240 |
| 17 | Fluorouracil, 50.0 mg/ml | > 240 |
| 18 | Gemcitabine 38.0 mg/ml | > 240 |
| 19 | Idaribicin 1.0 mg/ml | > 240 |
| 20 | Ifosfamide 50.0 mg/ml | > 240 |
| 21 | Irinotecan 20.0 mg/ml | > 240 |
| 22 | Mechlorethamine HCl 1.0 mg/ml | > 240 |
| 23 | Melphalan 5 mg/ml | > 240 |
| 24 | Methotrexate 25 mg/ml | > 240 |
| 25 | Mitomycin C 0.5 mg/ml | > 240 |
| 26 | Mitoxantrone 2.0 mg/ml | > 240 |
| 27 | Oxaliplatin 2.0 mg/ml | > 240 |
| 28 | Paclitaxel (Taxol), 6.0 mg/ml | > 240 |
| 29 | Paraplatin 10 mg/ml | > 240 |
| 30 | Retrovir 10 mg/ml | > 240 |
| 31 | Rituximab 10 mg/ml | > 240 |
| 32 | Thiotepa, 10.0 mg/ml | 118.5 |
| 33 | Topotecan HCl 1 mg/ml | > 240 |
| 34 | Trisonex 1 mg/ml | > 240 |
| 35 | Velcade (Bortezomib) 1 mg/ml | > 240 |
| 36 | Vincristine 1.0 mg/ml | > 240 |
The maximum testing time is 240 minutes. Please note that the following drug has an extremely low permeation time:
| Carmustine (BCNU), 3.3 mg/ml | 59.4 minutes |
|---|---|
| Thiotepa, 10.0 mg/ml | 118.5 minutes |
7.0 Summary of the Technological Characteristics of the Device:
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs are
6
summarized with the following technological characteristics compared to ASTM or equivalent standard. Table 5.3 Summary of the Technological Characteristics
| Characteristics | Standard |
|---|---|
| Dimension | ASTM standard D 6319-10(Reapproved 2015) |
| Length ≥230mm | |
| Width X Small 70 ± 10 mm | |
| Small 80 ± 10 mm | |
| Medium 95 ± 10 mm | |
| Large 110 ± 10 mm | |
| X large 120 ± 10 mm | |
| Thickness | |
| Finger tip ≥0.05mm | |
| Palm ≥0.05mm | |
| Physical Properties | ASTM standard D 6319-10 (Reapproved 2015) |
| Tensile strength (Before aging) ≥14MPa | |
| Tensile strength (After aging) ≥14MPa | |
| Elongated rate (Before aging) ≥500% | |
| Elongated rate (After aging) ≥400% | |
| Freedom from | |
| pinholes | 21 CFR 800.20 |
| ASTM standard D 6319-10 (Reapproved 2015) | |
| Test method in accordance with ASTM | |
| D5151-06(Reapproved 2015) | |
| Passed Standard Acceptance Criteria | |
| Powder Residual | ASTM standard D6319-10(Reapproved 2015) |
| Test method in accordance with | |
| D6124-06(Reaffirmation 2011) | |
| Tensile strength (Before aging/After aging) and Elongation (Before aging/After aging) per ASTM D6319-10(Reapproved 2015) |
-
Water leak test on pinhole per ASTM D6319-10(Reapproved 2015) and per 21 CFR 800.20.
- A Powder Residual tests per ASTM D6319-10(Reapproved 2015)
- A Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01.
-
Assessment Of Resistance To Permeation By Chemotherapy Drugs per ASTM D6978-05(R 2013)
9.0 Based on Assessment of Clinical Performance Data:
Clinical data was not needed to demonstrate that the subject glove is substantially equivalent to the predicate glove. So determination of substantial equivalence is not based on an assessment of clinical performance data.
7
10.0 Substantial Equivalence Comparison:
Table 5.4 SE compare
| Device
| Characteristic | Predicate Device | Proposed Device | Comparison | |
|---|---|---|---|---|
| Product name | Central Medicare Blue Non Sterile | |||
| Powder Free Nitrile Examination Gloves | ||||
| Tested For Use With Chemotherapy | ||||
| Drugs | Disposable Powder Free Nitrile | |||
| Examination Glove, Blue Color, Tested For | ||||
| Use With Chemotherapy Drugs | N/A | |||
| 510(K) No. | K173942 | K190736 | N/A | |
| Product | ||||
| Owner | Central Medicare Sdn. Bhd. | Ever Growth Enterprise Corporation | Different | |
| Product Code | LZA, LZC | LZA, LZC | same | |
| Regulation | 21 CFR 880.6250 | 21 CFR 880.6250 | same | |
| Class | I | I | same | |
| Intended Use | Blue Non Sterile Powder-Free Nitrile | |||
| Examination glove Tested For Use With | ||||
| Chemotherapy Drugs 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. Gloves | ||||
| have been tested for use with | ||||
| chemotherapy drugs using ASTM | ||||
| D6978-05 and will be labeled with a | ||||
| statement of compliance and a summary | ||||
| of the testing result. | A patient examination gloves is a | |||
| disposable device intended for medical | ||||
| purpose that is worn on the examiner's | ||||
| hand or fingers to prevent contamination | ||||
| between patient and examiner. In | ||||
| addition, these gloves were tested for use | ||||
| with chemotherapy drugs in accordance | ||||
| with ASTM D6978-05 Standard Practice | ||||
| for Assessment of Medical gloves to | ||||
| Permeation by Chemotherapy Drugs. | similar | |||
| Power free | Yes | Yes | same | |
| Size | X Small/Small/ Medium/Large/X Large | X Small/ Small/ Medium/Large/X Large | similar | |
| Single Use | YES | YES | same | |
| Non-Sterile | YES | YES | same | |
| Dimensions- | ||||
| Length | Complies with ASTM D6319-10 | |||
| 230 mm min. | Complies with ASTM D6319-10 | |||
| 230 mm min. | same | |||
| Dimensions | ||||
| -Palm Width | Complies with ASTM D6319-10 | |||
| X Small 70±10 | ||||
| Small 80 ±10 | ||||
| Medium 95±10 | ||||
| Large 110 ±10 | ||||
| X large 120 ±10 | Complies with ASTM D6319-10 | |||
| X Small 70±10 | ||||
| Small 80 ±10 | ||||
| Medium 95±10 | ||||
| Large 110 ±10 | ||||
| X large 120 ±10 | same | |||
| Dimensions | ||||
| -Thickness | Complies with ASTM D6319-10 | |||
| Palm - 0.08 mm min. | ||||
| Finger - 0.10 mm min. | Complies with ASTM D6319-10 | |||
| Palm - 0.05mm min. | ||||
| Finger - 0.05 mm min. | similar | |||
| Physical | ||||
| Properties | Tensile Strength: | |||
| Before Aging 15 MPa, min. | ||||
| After Aging 14 MPa, min. | ||||
| Elongation: | ||||
| Before Aging 500% min. | ||||
| After Aging 400% min. | Tensile Strength: | |||
| Before Aging 14 MPa, min. | ||||
| After Aging 14 MPa, min. | ||||
| Elongation: | ||||
| Before Aging 500% min. | ||||
| After Aging 400% min. | same | |||
| Residual | ||||
| powder | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | same | |
| Freedom | ||||
| from Holes | In accordance with ASTM D6319-10 and | |||
| ASTM D5151-06(reapproved 2011), G-1, | ||||
| AQL 2.5 | In accordance with ASTM D6319-10 and | |||
| ASTM D5151-06(reapproved 2011), G-1, | ||||
| AQL 2.5 | same | |||
| Bio- | ||||
| compatibility | AAMI/ANSI/ISO 10993-10 | |||
| Passes | ||||
| Not a skin irritant & Not a skin sensitizer | AAMI/ANSI/ISO 10993-10 | |||
| Skin sensitization test & Skin Irritation | ||||
| test: | ||||
| Passes | ||||
| AAMI/ ANSI/ ISO 10993-5 | ||||
| In vitro cytotoxicity test: | ||||
| Passes | Similar | |||
| Chemotherapy drugs tested | Breakthrough Detection Time in Minutes | comparison | ||
| Device Characteristic | Predicate device | Proposed Device | ||
| Blue | Blue | |||
| Bleomycin Sulfate 15.0 mg/ml | > 240 | > 240 | same | |
| Busulfan 6.0 mg/ml | > 240 | > 240 | same | |
| Carboplatin 10.0 mg/ml | > 240 | > 240 | same | |
| Carmustine (BCNU), 3.3 mg/ml | 12.4 | 59.4 | similar | |
| Chloroquine 50.0 mg/ml | > 240 | > 240 | same | |
| Cisplatin 1 mg/ml | > 240 | > 240 | same | |
| Cyclophosphamide 20 mg/ml | > 240 | > 240 | same | |
| Cyclosporin A 100.0 mg/ml | > 240 | > 240 | same | |
| Cytarabine 100.0 mg/ml | > 240 | > 240 | same | |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 | > 240 | same | |
| Daunorubicin 5.0 mg/ml | > 240 | > 240 | same | |
| Docetaxel 10.0 mg/ml | > 240 | > 240 | same | |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 | > 240 | same | |
| Epirubicin 2.0 mg/ml | > 240 | > 240 | same | |
| Etoposide (Toposar), 20.0 mg/ml | > 240 | > 240 | same | |
| Fludarabine 25.0 mg/ml | > 240 | > 240 | same | |
| Fluorouracil, 50.0 mg/ml | > 240 | > 240 | same | |
| Gemcitabine 38.0 mg/ml | > 240 | > 240 | same | |
| Idaribicin 1.0 mg/ml | > 240 | > 240 | same | |
| Ifosfamide 50.0 mg/ml | > 240 | > 240 | same | |
| Irinotecan 20.0 mg/ml | > 240 | > 240 | same | |
| Mechlorethamine HCl 1.0 mg/ml | > 240 | > 240 | same | |
| Melphalan 5 mg/ml | > 240 | > 240 | same | |
| Methotrexate 25 mg/ml | > 240 | > 240 | same | |
| Mitomycin C 0.5 mg/ml | > 240 | > 240 | same | |
| Mitoxantrone 2.0 mg/ml | > 240 | > 240 | same | |
| Oxaliplatin 2.0 mg/ml | > 240 | > 240 | same | |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 | > 240 | same | |
| Paraplatin 10 mg/ml | > 240 | > 240 | same | |
| Retrovir 10 mg/ml | > 240 | > 240 | same | |
| Rituximab 10 mg/ml | > 240 | > 240 | same | |
| Thiotepa, 10.0 mg/ml | 24.4 | 118.5 | similar | |
| Topotecan HCl 1 mg/ml | > 240 | > 240 | same | |
| Trisonex 1 mg/ml | > 240 | > 240 | same | |
| Velcade (Bortezomib) 1 mg/ml | > 240 | > 240 | same | |
| Vincristine 1.0 mg/ml | > 240 | > 240 | same |
8
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs
રાજ
9
11.0 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.