(167 days)
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 and fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical gloves to Permeation by Chemotherapy Drugs.
"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
This document describes the premarket notification (510(k)) for a medical device: "Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate" (K193555). The core of the submission, as it relates to proving the device meets acceptance criteria, focuses on the glove's resistance to permeation by chemotherapy drugs and fentanyl citrate.
Here's an analysis of the provided information to answer your questions:
1. A table of acceptance criteria and the reported device performance
The primary acceptance criteria for the chemotherapy drug and fentanyl citrate resistance are the "Minimum Breakthrough Detection Time (Min.)" as per ASTM D6978-05. The device aims to achieve a breakthrough time of "> 240 minutes" for most listed drugs.
| Test Chemotherapy Drug / Fentanyl Citrate | Concentration (mg/ml or mcg/2mL) | Acceptance Criteria (Minimum Breakthrough Detection Time) | Reported Device Performance (Breakthrough Detection Time - Short Cuff) | Reported Device Performance (Breakthrough Detection Time - Long Cuff) |
|---|---|---|---|---|
| Arsenic Trioxide | 1.0 | > 240 min | > 240 min | N/A |
| Azacitidine (Vidaza) | 25.0 | > 240 min | > 240 min | N/A |
| Bendamustine HCl | 5.0 | > 240 min | > 240 min | N/A |
| Bleomycin Sulfate | 15.0 | > 240 min | > 240 min | N/A |
| Bortezomib (Velcade) | 1.0 | > 240 min | > 240 min | N/A |
| Busulfan | 6.0 | > 240 min | > 240 min | N/A |
| Carboplatin | 10.0 | > 240 min | > 240 min | N/A |
| Carfilzomib | 2.0 | > 240 min | > 240 min | N/A |
| Carmustine (BCNU) | 3.3 | Not specified for new device directly, but predicate showed 6.2 min. New device aims to show improved or similar performance. | 21.5 min | 37.5 min |
| Cetuximab (Erbitux) | 2.0 | > 240 min | > 240 min | N/A |
| Chloroquine | 50.0 | > 240 min | > 240 min | N/A |
| Cisplatin | 1.0 | > 240 min | > 240 min | N/A |
| Cladribine | 1.0 | > 240 min | > 240 min | N/A |
| Cyclophosphamide | 20.0 | > 240 min | > 240 min | N/A |
| Cyclosporine A | 100.0 | > 240 min | > 240 min | N/A |
| Cytarabine | 100.0 | > 240 min | > 240 min | N/A |
| Cytovene (Ganciclovir) | 10.0 | > 240 min | > 240 min (Found in Indications for Use table, not explicitly in the detailed comparison table) | N/A |
| Dacarbazine | 10.0 | > 240 min | > 240 min | N/A |
| Daunorubicin | 5.0 | > 240 min | > 240 min | N/A |
| Decitabine | 5.0 | > 240 min | > 240 min | N/A |
| Docetaxel | 10.0 | > 240 min | > 240 min | N/A |
| Doxorubicin Hydrochloride | 2.0 | > 240 min | > 240 min | N/A |
| Epirubicin (Ellence) | 2.0 | > 240 min | > 240 min | N/A |
| Etoposide | 20.0 | > 240 min | > 240 min | N/A |
| Fludarabine | 25.0 | > 240 min | > 240 min | N/A |
| Fluorouracil | 50.0 | > 240 min | > 240 min | N/A |
| Fulvestrant | 50.0 | > 240 min | > 240 min | N/A |
| Gemcitabine | 38.0 | > 240 min | > 240 min | N/A |
| Idarubicin | 1.0 | > 240 min | > 240 min | N/A |
| Ifosfamide | 50.0 | > 240 min | > 240 min | N/A |
| Irinotecan | 20.0 | > 240 min | > 240 min | N/A |
| Mechlorethamine HCl | 1.0 | > 240 min | > 240 min | N/A |
| Melphalan | 5.0 | > 240 min | > 240 min | N/A |
| Methotrexate | 25.0 | > 240 min | > 240 min | N/A |
| Mesna | 100.0 | > 240 min | > 240 min | N/A |
| Mitomycin C | 0.5 | > 240 min | > 240 min | N/A |
| Mitoxantrone | 2.0 | > 240 min | > 240 min | N/A |
| Oxaliplatin | 5.0 | > 240 min | > 240 min | N/A |
| Paclitaxel | 6.0 | > 240 min | > 240 min | N/A |
| Paraplatin | 10.0 | > 240 min | > 240 min | N/A |
| Pemetrexed | 25.0 | > 240 min | > 240 min | N/A |
| Pertuzumab | 30.0 | > 240 min | > 240 min | N/A |
| Raltitrexed | 0.5 | > 240 min | > 240 min | N/A |
| Retrovir | 10.0 | > 240 min | > 240 min | N/A |
| Rituximab | 10.0 | > 240 min | > 240 min | N/A |
| Temsirolimus | 25.0 | > 240 min | > 240 min | N/A |
| Thiotepa | 10.0 | Not specified for new device directly, but predicate showed 38.8 min. New device aims to show improved or similar performance. | 23.1 min | 13.6 min |
| Topotecan HCl | 1.0 | > 240 min | > 240 min | N/A |
| Trastuzumab | 21.0 | > 240 min | > 240 min | N/A |
| Triclosan | 2.0 | > 240 min | > 240 min | N/A |
| Trisenox | 1.0 | > 240 min | > 240 min | N/A |
| Vinblastine | 1.0 | > 240 min | > 240 min | N/A |
| Vincristine Sulfate | 1.0 | > 240 min | > 240 min | N/A |
| Vinorelbine | 10.0 | > 240 min | > 240 min | N/A |
| Zoledronic Acid | 0.8 | > 240 min | > 240 min | N/A |
| Fentanyl Citrate Injection | 100 mcg/2mL | > 240 min | > 240 min | N/A |
Note on Acceptance Criteria: For most drugs, the stated acceptance criterion is explicitly given as "> 240 minutes" in the "Indications for Use" section and confirmed by the reported performance. For Carmustine and Thiotepa, the document highlights their "extremely low permeation time" and provides their specific breakthrough times. The comparison table (Table 2) then compares these to the predicate, showing the new device's performance. The "Warning: do not use with Carmustine and Thiotepa" statement effectively sets the acceptance criteria for these specific drugs as less than the ideal >240 minutes, acknowledging their known rapid permeation through gloves. The aim for these is to show performance comparable or better than the predicate, which the subject device achieves for Carmustine, but is slightly worse for Thiotepa (Thiotepa: predicate 38.8 min, subject device 23.1 min (short cuff) and 13.6 min (long cuff)). However, since a warning is issued, this outcome appears to be accepted.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not explicitly state the specific number of gloves/samples tested for each drug permeation. It refers to testing "in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs," which would define the sample size requirements for the test. However, the exact sample numbers (e.g., how many gloves were tested for each drug) are not provided in this summary.
- Data Provenance: The tests were conducted by Ever Global (Vietnam) Enterprise Corp (Vietnam). The type of study for these tests would be prospective bench testing, as new gloves were manufactured and then tested for their characteristics.
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 is a device performance study based on laboratory bench testing, not an AI or diagnostic study involving expert interpretation of medical images. Therefore:
- Number of experts: Not applicable. Ground truth for material properties (like drug permeation) is established through standardized laboratory procedures and measurements.
- Qualifications of experts: Not applicable in the context of human expert review of "ground truth" for clinical data. The "experts" here would be the laboratory personnel qualified to perform ASTM D6978-05 and other relevant material testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human reader interpretation or adjudication. Device performance is determined by direct physical and chemical testing according to established ASTM 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
Not applicable. This is a 510(k) submission for a physical medical device (gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm. The "standalone performance" is the intrinsic material property of the glove against chemical permeation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance regarding chemotherapy drug and fentanyl permeation is established through direct laboratory measurement using the methodology outlined in ASTM D6978-05. This standard defines how resistance to permeation is assessed, with breakthrough time being the key metric. For other properties like tensile strength, freedom from holes, powder residual, and biocompatibility, the ground truth is also established by specific ASTM standards and biological evaluation guidelines (e.g., ISO 10993).
8. The sample size for the training set
Not applicable. This is a traditional device submission, not an AI/machine learning product that requires a "training set." The gloves are manufactured, and then samples from the manufacturing batches are subjected to testing (the "test set" in this context).
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 4, 2020
Ever Global (Vietnam) Enterprise Corp % Elizabeth Deng U.S. Representative Elizabeth Deng 5748 Eaglewood Place Ranch Cucamonga, California 91730
Re: K193555
Trade/Device Name: Disposable Powder Free Nitrile Examination Glove, Blue Color, 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: LZC, LZA, QDO Dated: April 29, 2020 Received: May 5, 2020
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 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.
CAPT 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
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Ever Global (Vietnam) Enterprise Corporation
Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below. | |||
|---|---|---|---|---|
| Indications for Use | ||||
| 510(k) Number (if known) | K193555 | |||
| Device Name | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate | |||
| Indications for Use (Describe) | A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand orfingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use withchemotherapy drugs and fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment ofResistance of Medical gloves to Permeation by Chemotherapy Drugs. | |||
| Test Chemotherapy Drug | Concentration (mg/ml) | Minimum Breakthrough Detection Time (Min.) | ||
| 01 Arsenic Trioxide | 1.0 | > 240 | ||
| 02 Azacitidine (Vidaza) | 25.0 | > 240 | ||
| 03 Bendamustine HCl | 5.0 | > 240 | ||
| 04 Bleomycin Sulfate | 15.0 | > 240 | ||
| 05 Bortezomib (Velcade) | 1.0 | > 240 | ||
| 06 Busulfan | 6.0 | > 240 | ||
| 07 Carboplatin | 10.0 | > 240 | ||
| 08 Carfilzomib | 2.0 | > 240 | ||
| 09 Carmustine (BCNU) | 3.3 | 6.2 | ||
| 10 Cetuximab (Erbitux) | 2.0 | > 240 | ||
| 11 Chloroquine | 50.0 | > 240 | ||
| 12 Cisplatin | 1.0 | > 240 | ||
| 13 Cladribine | 1.0 | > 240 | ||
| 14 Cyclophosphamide | 20.0 | > 240 | ||
| 15 Cyclosporine A | 100.0 | > 240 | ||
| 16 Cytarabine mg/ml) | 100.0 | > 240 | ||
| 17 Cytovene (Ganciclovir) | 10.0 | > 240 | ||
| 18 Dacarbazine | 10.0 | > 240 | ||
| 19 Daunorubicin | 5.0 | > 240 | ||
| 20 Decitabine | 5.0 | > 240 | ||
| 21 Docetaxel | 10.0 | > 240 | ||
| 22 Doxorubicin Hydrochloride | 2.0 | > 240 | ||
| 23 Epirubicin (Ellence) | 2.0 | > 240 | ||
| 24 Etoposide | 20.0 | > 240 | ||
| 25 Fludarabine | 25.0 | > 240 | ||
| 26 Fluorouracil | 50.0 | > 240 | ||
| 27 Fulvestrant | 50.0 | > 240 | ||
| 28 Gemcitabine | 38.0 | > 240 | ||
| 29 Idarubicin | 1.0 | > 240 | ||
| 30 Ifosfamide | 50.0 | > 240 | ||
| 31 Irinotecan | 20.0 | > 240 | ||
| 32 Mechlorethamine HCl | 1.0 | > 240 | ||
| 33 Melphalan | 5.0 | > 240 | ||
| 34 Methotrexate | 25.0 | > 240 | ||
| 35 Mesna | 100.0 | > 240 | ||
| 36 Mitomycin C | 0.5 | > 240 | ||
| 37 Mitoxantrone | 2.0 | > 240 | ||
| FORM FDA 3881 (7/17) | Page 1 of 2 | PSC Publishing Services (301) 443-6740 |
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Ever Global (Vietnam) Enterprise Corporation
Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, Vietnam
| 38 Oxaliplatin | 5.0 | > 240 |
|---|---|---|
| 39 Paclitaxel | 6.0 | > 240 |
| 40 Paraplatin | 10.0 | > 240 |
| 41 Pemetrexed | 25.0 | > 240 |
| 42 Pertuzumab | 30.0 | > 240 |
| 43 Raltitrexed | 0.5 | > 240 |
| 44 Retrovir | 10.0 | > 240 |
| 45 Rituximab | 10.0 | > 240 |
| 46 Temsirolimus | 25.0 | > 240 |
| 47 Thiotepa | 10.0 | 13.6 |
| 48 Topotecan HCl | 1.0 | > 240 |
| 49 Trastuzumab | 21.0 | > 240 |
| 50 Triclosan | 2.0 | > 240 |
| 51 Trisenox | 1.0 | > 240 |
| 52 Vinblastine | 1.0 | > 240 |
| 53 Vincristine Sulfate | 1.0 | > 240 |
| 54 Vinorelbine | 10.0 | > 240 |
| 55 Zoledronic Acid | 0.8 | > 240 |
| Warning: do not use with Carmustine and Thiotepa.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 | 6.2 minutes |
| Thiotepa | 10.0 mg/ml | 13.6 minutes |
| Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl CitrateInjection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes. | ||
| Type of Use (Select one or both, as applicable) | ||
| Image: Checkbox | Over-The-Counter Use (21 CFR 801 Subpart C) | |
| Image: Unchecked checkbox | Prescription Use (Part 21 CFR 801 Subpart D) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||
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510(K) SUMMARY
K193555
1.0 Submitter:
| Submitter's name : | Ever Global (Vietnam) Enterprise Corp. | |
|---|---|---|
| Submitter's address : | Long Thanh Industrial ZoneTaman Village Dong Nai Province, VN 810000 | |
| Phone number : | 84-61-3514022 | |
| Fax number : | 84 -61-3514023 | |
| Name of contact person: | Jerry Lin | |
| Summary Preparation Date: | May 27th,2020 | |
| 2.0 US Agent: | ||
| US representative name: | Elizabeth Deng | |
| Company address: | 5748 Eaglewood PlaceRancho Cuamonga, CaliforniaRancho 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 ForUse With Chemotherapy Drugs and Fentanyl Citrate | |
| Common Name: | Nitrile Examination Gloves | |
| Classification Name: | Patient Examination Glove | |
| Device Classification: | Class I | |
| Regulation Number: | 21 CFR 880.6250 | |
| Product Code: | LZA, LZC, QDO | |
| 4.0 Predicate device | ||
| Device Name: | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested ForUse With Chemotherapy Drugs | |
| Company name: | Ever Global (Vietnam) Enterprise Corp. | |
| 510(K) Number: | K190403 |
5.0 Device Description:
"Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate" is a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of this medical device is to provide single use barrier protection for the wearer and the device meets the specifications for Barrier Protection and tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
6.0 Indication for use:
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate
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 resistance of medical gloves to permeation by chemotherapy drugs.
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| No. | Test Chemotherapy Drug andConcentration | Minimum BreakthroughDetection Time (Min.) |
|---|---|---|
| 1 | Arsenic Trioxide (1.0 mg/ml) | > 240 |
| 2 | Azacitidine (Vidaza) (25.0 mg/ml) | > 240 |
| 3 | Bendamustine HCl (5.0 mg/ml) | > 240 |
| 4 | Bleomycin Sulfate (15.0 mg/ml) | > 240 |
| 5 | Bortezomib (Velcade) (1.0 mg/ml) | > 240 |
| 6 | Busulfan (6.0 mg/ml) | > 240 |
| 7 | Carboplatin (10.0 mg/ml) | > 240 |
| 8 | Carfilzomib (2.0 mg/ml) | > 240 |
| 9 | Carmustine (BCNU), (3.3 mg/ml) | 6.2 |
| 10 | Cetuximab (Erbitux) (2.0 mg/ml) | > 240 |
| 11 | Chloroquine (50.0 mg/ml) | > 240 |
| 12 | Cisplatin (1.0 mg/ml) | > 240 |
| 13 | Cladribine (1.0 mg/ml) | > 240 |
| 14 | Cyclophosphamide (20.0 mg/ml) | > 240 |
| 15 | Cyclosporine A (100.0 mg/ml) | > 240 |
| 16 | Cytarabine (100.0 mg/ml) | > 240 |
| 17 | Cytovene (Ganciclovir) (10.0 mg/ml) | > 240 |
| 18 | Dacarbazine (10.0 mg/ml) | > 240 |
| 19 | Daunorubicin (5.0 mg/ml) | > 240 |
| 20 | Decitabine (5.0 mg/ml) | > 240 |
| 21 | Docetaxel (10.0 mg/ml) | > 240 |
| 22 | Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| 23 | Epirubicin (Ellence) (2.0 mg/ml) | > 240 |
| 24 | Etoposide (20.0 mg/ml) | > 240 |
| 25 | Fludarabine (25.0 mg/ml) | > 240 |
| 26 | Fluorouracil (50.0 mg/ml) | > 240 |
| 27 | Fulvestrant (50.0 mg/ml) | > 240 |
| 28 | Gemcitabine (38.0 mg/ml) | > 240 |
| 29 | Idarubicin (1.0 mg/ml) | > 240 |
| 30 | Ifosfamide (50.0 mg/ml) | > 240 |
| 31 | Irinotecan (20.0 mg/ml) | > 240 |
| 32 | Mechlorethamine HCl (1.0 mg/ml) | > 240 |
| 33 | Melphalan (5.0 mg/ml) | > 240 |
| 34 | Methotrexate (25 mg/ml) | > 240 |
| 35 | Mesna (100 mg/ml) | > 240 |
| 36 | Mitomycin C (0.5 mg/ml) | > 240 |
| 37 | Mitoxantrone (2.0 mg/ml) | > 240 |
| 38 | Oxaliplatin (5.0 mg/ml) | > 240 |
| 39 | Paclitaxel (6.0mg/ml) | > 240 |
| 40 | Paraplatin (10.0 mg/ml) | > 240 |
| 41 | Pemetrexed (25.0 mg/ml) | > 240 |
| 42 | Pertuzumab (30.0 mg/ml) | > 240 |
| 43 | Raltitrexed (0.5 mg/ml) | > 240 |
| 44 | Retrovir (10.0 mg/ml) | > 240 |
| 45 | Rituximab (10.0 mg/ml) | > 240 |
| 46 | Temsirolimus (25.0 mg/ml) | > 240 |
| 47 | Thiotepa (10.0 mg/ml) | 13.6 |
| 48 | Topotecan HCl (1.0 mg/ml) | > 240 |
| 49 | Trastuzumab (21.0 mg/ml) | > 240 |
| 50 | Triclosan (2.0 mg/ml) | > 240 |
| 51 | Trisenox (1.0 mg/ml) | > 240 |
| 52 | Vinblastine (1.0 mg/ml) | > 240 |
| 53 | Vincristine Sulfate (1.0 mg/ml) | > 240 |
| 54 | Vinorelbine (10.0 mg/ml) | > 240 |
| 55 | Zoledronic Acid (0.8 mg/ml) | > 240 |
Table 1 Tested for use with 55 chemotherapy drugs.
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Warning: do not use with Carmustine and Thiotepa.
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 | 6.2 minutes |
|---|---|
| Thiotepa, 10.0 mg/ml | 13.6 minutes |
Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected for up to 240 minutes.
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7.0 Comparison of Technological characteristics between the predicate and subject devices:
| Device Characteristic | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Product name | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate | similar |
| 510(K) No. | K190403 | K193555 | N/A |
| Product Owner | Ever Global (Vietnam) Enterprise Corporation | Ever Global (Vietnam) Enterprise Corporation | same |
| Product Code | LZA, LZC | LZA, LZC, QDO | similar |
| Regulation | 21 CFR 880.6250 | 21 CFR 880.6250 | same |
| Class | I | I | same |
| Intended Use | The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. | The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs And Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs. | similar |
| Powder free | Yes | Yes | same |
| Size | Small/ Medium/Large/X Large | X Small/ Small/Medium/Large/X Large | X Small is additional. |
| Single Use | YES | YES | same |
| Non-Sterile | No | No | same |
| Dimensions-Length | Complies with ASTM D6319-10 230 mm min. | Short cuff ≥230mmLong cuff ≥300mm | Long cuff is additional. |
| Dimensions - Palm Width | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | Similar.X Small is additional. |
| SmallMediumLarge | X Small 70±10Small 80±10Medium 95 ±10Large 110±10 |
Table 2 Comparison of Technological Characteristics
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| Dimensions - Thickness | Complies with ASTM D6319-10Palm 0.05mm min.Finger 0.05 mm min.Cuff 0.05 mm min | Complies with ASTM D6319-10Palm 0.05mm min.Finger 0.05 mm min.Cuff 0.05 mm min | same | ||
|---|---|---|---|---|---|
| PhysicalProperties | Tensile Strength:Before Aging 14 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 | ||
| Residualpowder | Complies with ASTM D6319-10< 2mg per glove | Complies with ASTM D6319-10< 2mg per glove | same | ||
| Freedom fromHoles | In accordance with ASTM D6319-10 and ASTM D5151- 06(reapproved 2015), G-1, AQL 2.5 | In accordance with ASTM D6319-10 and ASTM D5151-06(reapproved 2015), G-1, AQL 2.5 | same | ||
| Biocompatibility | AAMI/ANSI/ISO 10993-10PassesNot a skin irritant & Not a skinsensitizer | AAMI/ANSI/ISO 10993-10 &AAMI/ANSI/ISO 10993-5PassesNot a skin irritant, Not a skinsensitizer & No cytotoxicityreaction | same | ||
| Chemotherapy drugs tested | Breakthrough Detection Time in Minutes | Comparison | |||
| Predicatedevice | Subject Device | ||||
| Device Characteristic | K190403 | Short Cuff | Long Cuff | ||
| Arsenic Trioxide (1.0 mg/ml) | - | > 240 | Different | ||
| Azacitidine (Vidaza) (25.0 mg/ml) | - | > 240 | Different | ||
| Bendamustine HCI (5.0 mg/ml) | - | > 240 | Different | ||
| Bleomycin Sulfate (15.0 mg/ml) | - | > 240 | Different | ||
| Bortezomib (Velcade) (1.0 mg/ml) | - | > 240 | Different | ||
| Busulfan (6.0 mg/ml) | - | > 240 | Different | ||
| Carboplatin (10.0 mg/ml) | - | > 240 | Different | ||
| Carfilzomib (2.0 mg/ml) | - | > 240 | Different | ||
| Carmustine (BCNU), (3.3 mg/ml) | 6.2 | 21.5 | 37.5 | Similar | |
| Cetuximab (Erbitux) (2.0 mg/ml) | - | > 240 | Different | ||
| Chloroquine (50.0 mg/ml) | - | > 240 | Different | ||
| Cisplatin (1.0 mg/ml) | > 240 | > 240 | Same | ||
| Cladribine (1.0 mg/ml) | - | > 240 | Different | ||
| Cyclophosphamide (20.0 mg/ml) | > 240 | > 240 | Same | ||
| Cyclosporin A (100.0 mg/ml) | - | > 240 | Different | ||
| Cytarabine (100.0 mg/ml) | - | > 240 | Different | ||
| Dacarbazine (DTIC), (10.0 mg/ml) | > 240 | > 240 | Same | ||
| Daunorubicin (5.0 mg/ml) | - | > 240 | Different | ||
| Decitabine (5.0 mg/ml) | - | > 240 | Different | ||
| Docetaxel (10.0 mg/ml) | - | > 240 | Different | ||
| Doxorubicin Hydrochloride (2.0mg/ml) | > 240 | > 240 | Same | ||
| Epirubicin (Ellence) (2.0 mg/ml) | - | > 240 | Different | ||
| Etoposide, (20.0 mg/ml) | > 240 | > 240 | Same | ||
| Fludarabine (25.0 mg/ml) | - | > 240 | Different | ||
| Fluorouracil, (50.0 mg/ml) | > 240 | > 240 | Same | ||
| Fulvestrant (50.0 mg/ml) | - | > 240 | Different | ||
| Gemcitabine (38.0 mg/ml) | - | > 240 | Different | ||
| Idaribicin (1.0 mg/ml) | - | > 240 | Different | ||
| Ifosfamide (50.0 mg/ml) | - | > 240 | Different | ||
| Irinotecan (20.0 mg/ml) | - | > 240 | Different | ||
| Mechlorethamine HCl (1.0 mg/ml) | - | > 240 | Different | ||
| Melphalan (5.0 mg/ml) | - | > 240 | Different | ||
| Methotrexate (25 mg/ml) | - | > 240 | Different | ||
| Mesna (100 mg/ml) | - | > 240 | Different | ||
| Mitomycin C (0.5 mg/ml) | - | > 240 | Different | ||
| Mitoxantrone (2.0 mg/ml) | - | > 240 | Different | ||
| Oxaliplatin (5.0 mg/ml) | - | > 240 | Different | ||
| Paclitaxel (Taxol), (6.0 mg/ml) | > 240 | > 240 | Same | ||
| Paraplatin (10.0 mg/ml) | - | > 240 | Different | ||
| Pemetrexed (25.0 mg/ml) | - | > 240 | Different | ||
| Pertuzumab (30.0 mg/ml) | - | > 240 | Different | ||
| Raltitrexed (0.5 mg/ml) | - | > 240 | Different | ||
| Retrovir (10.0 mg/ml) | - | > 240 | Different | ||
| Rituximab (10.0 mg/ml) | - | > 240 | Different | ||
| Temsirolimus (25.0 mg/ml) | - | > 240 | Different | ||
| Thiotepa (10.0 mg/ml) | 38.8 | 23.1 | 13.6 | Similar | |
| Topotecan HCl (1.0 mg/ml) | - | > 240 | Different | ||
| Trastuzumab (21.0 mg/ml) | - | > 240 | Different | ||
| Triclosan (2.0 mg/ml) | - | > 240 | Different | ||
| Trisenox (1.0 mg/ml) | - | > 240 | Different | ||
| Vinblastine (1.0 mg/ml) | - | > 240 | Different |
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| Vincristine Sulfate (1.0 mg/ml) | - | > 240 | Different |
|---|---|---|---|
| Vinorelbine (10.0 mg/ml) | - | > 240 | Different |
| Zoledronic Acid (0.8 mg/ml) | - | > 240 | Different |
| Fentanyl Permeation Resistance | |||
| Fentanyl Citrate Injection, (100mcg/2ml) | - | > 240 | Different |
8.0 Summary of Non-clinical testing results:
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate is summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard |
|---|---|
| Dimension | ASTM standard D 6319-10(Reapproved 2015) |
| LengthShort cuff≥230mmLong cuff≥300mm | |
| WidthX Small$70 \pm 10 mm$Small$80 \pm 10 mm$Medium$95 \pm 10 mm$Large$110 \pm 10 mm$X large$120 \pm 10 mm$ | |
| ThicknessFinger tip≥0.05mmPalm≥0.05mmCuff≥0.05mm | |
| PhysicalProperties | ASTM standard D 6319-10(Reapproved 2015)Tensile strength (Before aging)≥14MPaTensile strength (After aging)≥14MPaElongated rate (Before aging)≥500%Elongated rate (After aging)≥400% |
| Freedom frompinholes | 21 CFR 800.20ASTM 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)< 2 mg/glove |
| Biocompatibility | Primary Skin Irritation in rabbitsPassUnder the conditions of the study, the subject device is not a primary skin irritant.Dermal sensitization in the guinea pigPassUnder the conditions of the study, the subject device is not a primary skin sensitizer.In vitro cytotoxicityPassUnder the conditions of the study, the subject device is not shown cytotoxicity. |
Table 3 Summary of the Technological Characteristics
The following bench testing was conducted for the Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate made by Ever Global (Vietnam) Enterprise Corp:
- Dimension per ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination ● Gloves for Medical Application
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- Tensile strength(Before aging/After aging) and Elongation(Before aging/After aging) per ASTM D6319-10(Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application
- Water leak test on pinhole per ASTM D6319-10(Reapproved 2015) Standard Specification for ● Nitrile Examination Gloves for Medical Application and per 21 CFR 800.20 Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects;adulteration.
- Powder Residual tests per ASTM D6319-10(Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application.
- . Biocompatibility test per ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity & ISO 10993-10: Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization.
- . Assessment Of Resistance To Permeation By Chemotherapy Drugs And Fentanyl Citrate per ASTM D6978-05(R 2013) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
9.0 Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device the Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K190403.
§ 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.