(265 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 in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White Color and Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color are a 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.
The provided document describes a 510(k) premarket notification for disposable powder-free nitrile examination gloves, tested for use with chemotherapy drugs. This type of filing is for demonstrating substantial equivalence to a predicate device, not for proving the performance of an AI/ML powered device.
Therefore, the requested information regarding acceptance criteria and studies for an AI-powered device, including details like sample sizes for test and training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this document.
The document focuses on the physical and chemical properties of the gloves and their resistance to chemotherapy drug permeation, comparing them to established standards and a predicate glove. The "device" in this context is a physical medical glove, not an AI/ML diagnostic or assistive tool.
However, I can extract the acceptance criteria and reported performance for the glove from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the medical gloves are primarily based on ASTM standards (ASTM D6319-10 updated 2015 for Nitrile Examination Gloves and ASTM D6978-05 for chemotherapy drug permeation) and 21 CFR 800.20 for freedom from pinholes.
Table: Acceptance Criteria and Reported Device Performance for Disposable Powder Free Nitrile Examination Gloves
| Characteristic | Acceptance Criteria | Reported Device Performance (White Color Glove) | Reported Device Performance (Orange Color Glove) |
|---|---|---|---|
| Dimensions: | Standard: ASTM D6319-10 (Reapproved 2015) | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 |
| Length | $\ge$ 230 mm | $\ge$ 230 mm | $\ge$ 230 mm |
| Palm Width (X Small) | 70 $\pm$ 10 mm | 70 $\pm$ 10 mm | 70 $\pm$ 10 mm |
| Palm Width (Small) | 80 $\pm$ 10 mm | 80 $\pm$ 10 mm | 80 $\pm$ 10 mm |
| Palm Width (Medium) | 95 $\pm$ 10 mm | 95 $\pm$ 10 mm | 95 $\pm$ 10 mm |
| Palm Width (Large) | 110 $\pm$ 10 mm | 110 $\pm$ 10 mm | 110 $\pm$ 10 mm |
| Palm Width (X Large) | 120 $\pm$ 10 mm | 120 $\pm$ 10 mm | 120 $\pm$ 10 mm |
| Thickness (Fingertip) | $\ge$ 0.05 mm | $\ge$ 0.05 mm (minimum, implied by "Complies with ASTM D6319-10") | $\ge$ 0.05 mm (minimum, implied by "Complies with ASTM D6319-10") |
| Thickness (Palm) | $\ge$ 0.05 mm | $\ge$ 0.05 mm (minimum, implied by "Complies with ASTM D6319-10") | $\ge$ 0.05 mm (minimum, implied by "Complies with ASTM D6319-10") |
| Physical Properties: | Standard: ASTM D6319-10 (Reapproved 2015) | ||
| Tensile Strength (Before aging) | $\ge$ 14 MPa | $\ge$ 14 MPa | $\ge$ 14 MPa |
| Tensile Strength (After aging) | $\ge$ 14 MPa | $\ge$ 14 MPa | $\ge$ 14 MPa |
| Elongation (Before aging) | $\ge$ 500% | $\ge$ 500% | $\ge$ 500% |
| Elongation (After aging) | $\ge$ 400% | $\ge$ 400% | $\ge$ 400% |
| Freedom from Pinhole | Standard: 21 CFR 800.20 & ASTM D6319-10 (AQL 2.5) | Passed Standard Acceptance Criteria (in accordance with ASTM D5151-06) | Passed Standard Acceptance Criteria (in accordance with ASTM D5151-06) |
| Powder Residual | Standard: ASTM D6319-10 ($\le$ 2 mg/glove) | $\le$ 2 mg/glove (in accordance with D6124-06) | $\le$ 2 mg/glove (in accordance with D6124-06) |
| Biocompatibility | Standards: ISO 10993-10, ISO 10993-5 | Primary Skin Irritation: Passes (not a primary skin irritant) | Primary Skin Irritation: Passes (not a primary skin irritant) |
| Dermal Sensitization: Passes (not a primary skin sensitizer) | Dermal Sensitization: Passes (not a primary skin sensitizer) | ||
| In vitro cytotoxicity: Passes (not cytotoxic) | In vitro cytotoxicity: Passes (not cytotoxic) | ||
| Chemotherapy Drugs Permeation (ASTM D6978-05) | Minimum Breakthrough Detection Time (Min) | Minimum Breakthrough Detection Time (Min) | |
| Carmustine (BCNU) | Not specified an "acceptance criteria" but reported | 11.8 | 31.6 |
| Thiotepa | Not specified an "acceptance criteria" but reported | 16.9 | 72.5 |
| Cyclophosphamide (Cytoxan) | Not specified an "acceptance criteria" but reported | >240 | >240 |
| Cisplatin | Not specified an "acceptance criteria" but reported | >240 | >240 |
| Doxorubicin HCl | Not specified an "acceptance criteria" but reported | >240 | >240 |
| Fluorouracil | Not specified an "acceptance criteria" but reported | >240 | >240 |
| Dacarbazine (DTIC) | Not specified an "acceptance criteria" but reported | >240 | >240 |
| Etoposide (Toposar) | Not specified an "acceptance criteria" but reported | >240 | >240 |
| Paclitaxel (Taxol) | Not specified an "acceptance criteria" but reported | >240 | >240 |
Note: For chemotherapy drugs like Carmustine and Thiotepa, the document explicitly states warnings due to "extremely low permeation time," indicating these drugs do not meet a desired high breakthrough time, hence the warning not to use them with these gloves for prolonged periods. The "acceptance criteria" for these specific drugs seem to be met by simply reporting the actual breakthrough time, coupled with a warning. For the other drugs, >240 minutes indicates they exceeded the maximum testing time, which is generally desired for chemotherapy-resistant gloves.
Non-Applicable Information for AI/ML Devices:
The following points are tailored for AI/ML device evaluations and are not relevant to the provided document about medical gloves:
- Sample size used for the test set and the data provenance: Not applicable. Tests were bench-top physical/chemical tests on glove samples, not a data-driven AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth was established by laboratory measurements against ASTM standards.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Lab testing results are objective measurements.
- 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-powered device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for the glove was defined by internationally recognized standards (ASTM, ISO) for physical properties and chemical resistance.
- The sample size for the training set: Not applicable. There is no AI model or training set.
- How the ground truth for the training set was established: Not applicable. There is no AI model or training set.
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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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 23, 2019
Ever Growth (Vietnam) Co. Ltd. % Elizabeth Deng U.S. Representative Elizabeth Deng 5748 Eaglewood Place Rancho Cucamonga, California 91730
Re: K190860
Trade/Device Name: Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: September 30, 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 (OS) 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.
For 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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Indications for Use
510(k) Number (if known) K190860
Device Name
Thiotepa
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White Color
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) |
|---|---|---|
| 1 Carmustine (BCNU), | 3.3 mg/ml | 11.8 |
| 2 Thiotepa, | 10.0 mg/ml | 16.9 |
| 3 Cyclophosphamide (Cytoxan), | 20.0 mg/ml | >240 |
| 4 Cisplatin, | 1.0 mg/ml | >240 |
| 5 Doxorubicin Hydrochloride, | 2.0 mg/ml | >240 |
| 6 Fluorouracil, | 50.0 mg/ml | >240 |
| 7 Dacarbazine (DTIC), | 10.0 mg/ml | >240 |
| 8 Etoposide (Toposar), | 20.0 mg/ml | >240 |
| 9 Paclitaxel (Taxol), | 6.0 mg/ml | >240 |
Warning: Please do not use with Carmustine (BCNU) and Thiotepa
10.0 mg/ml
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.
16.9 minutes
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K190860
Device Name
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color
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) |
|---|---|---|
| 1 Carmustine (BCNU), | 3.3 mg/ml | 31.6 |
| 2 Thiotepa, | 10.0 mg/ml | 72.5 |
| 3 Cyclophosphamide (Cytoxan), | 20.0 mg/ml | >240 |
| 4 Cisplatin, | 1.0 mg/ml | >240 |
| 5 Doxorubicin Hydrochloride, | 2.0 mg/ml | >240 |
| 6 Fluorouracil, | 50.0 mg/ml | >240 |
| 7 Dacarbazine (DTIC), | 10.0 mg/ml | >240 |
| 8 Etoposide (Toposar), | 20.0 mg/ml | >240 |
| 9 Paclitaxel (Taxol), | 6.0 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 | 31.6 minutes |
|---|---|---|
| Thiotepa | 10.0 mg/ml | 72.5 minutes |
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
{4}------------------------------------------------
510(k) Summary
K190860
| 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 NaiVietnam | |
| 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 PlaceRancho Cucamonga, 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, Tested For Use WithChemotherapy Drugs, White ColorDisposable Powder Free Nitrile Examination Glove, Tested For Use WithChemotherapy Drugs, Orange Color |
| Common Name: | Nitrile Examination Gloves | |
| 510(k) Number | K190860 | |
| 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: | Powder-Free Nitrile Examination Gloves (Blue), Tested for Use withChemotherapy Drugs |
| Company name: | Syntex Healthcare Products Co., Ltd | |
| 510(K) Number: | K182156 | |
| 5.0 Device Description: |
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White Color and Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color are a 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, Tested For Use With Chemotherapy Drugs, White Color
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
{5}------------------------------------------------
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 | Carmustine (BCNU), 3.3 mg/ml | 11.8 |
| 2 | Thiotepa, 10.0 mg/ml | 16.9 |
| 3 | Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 |
| 4 | Cisplatin, 1.0 mg/ml | >240 |
| 5 | Doxorubicin Hydrochloride, 2.0 mg/ml | >240 |
| 6 | Fluorouracil, 50.0 mg/ml | >240 |
| 7 | Dacarbazine (DTIC), 10.0 mg/ml | >240 |
| 8 | Etoposide (Toposar), 20.0 mg/ml | >240 |
| 9 | Paclitaxel (Taxol), 6.0 mg/ml | >240 |
Table 6.1 Nitrile White color test for 7+2 chemotherapy drugs
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 | 11.8 minutes |
|---|---|
| Thiotepa, 10.0 mg/ml | 16.9 minutes |
Warning: Please do not use with Carmustine (BCNU) and Thiotepa
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color
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 | Carmustine (BCNU), 3.3 mg/ml | 31.6 |
| 2 | Thiotepa, 10.0 mg/ml | 72.5 |
| 3 | Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 |
| 4 | Cisplatin, 1.0 mg/ml | >240 |
| 5 | Doxorubicin Hydrochloride, 2.0 mg/ml | >240 |
| 6 | Fluorouracil, 50.0 mg/ml | >240 |
| 7 | Dacarbazine (DTIC), 10.0 mg/ml | >240 |
| 8 | Etoposide (Toposar), 20.0 mg/ml | >240 |
| 9 | Paclitaxel (Taxol), 6.0 mg/ml | >240 |
Table 6.2 Nitrile Orange color test for 7+2 chemotherapy drugs
The maximum testing time is 240 minutes.
Please note that the following drug has an extremely low permeation time:
{6}------------------------------------------------
| Carmustine (BCNU), 3.3 mg/ml | 31.6 minutes |
|---|---|
| Thiotepa, 10.0 mg/ml | 72.5 minutes |
7.0 Summary of the Technological Characteristics of the Device:
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White Color and Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color are summarized with the following technological characteristics compared to ASTM or equivalent standard. Table 5.3 Summary of the Technological Characteristics
| Characteristics | Standard | |
|---|---|---|
| Dimension | 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 800.20Passed Standard Acceptance Criteria | |
| ASTM standard D 6319-10 (Reapproved 2015)Test method in accordance with ASTMD5151-06(Reapproved 2015) | ||
| Powder Residual | ASTM standard D6319-10(Reapproved 2015)Test method in accordance withD6124-06(Reaffirmation 2011)< 2 mg/glove | |
| Biocompatibility | Primary Skin Irritation in rabbitsISO 10993-10: Third Edition2010-08-01 | PassesUnder the conditions of the study, the subject device is not a primary skin irritant. |
| Dermal sensitization in the guinea pigISO 10993-10: Third Edition2010-08-01 | PassesUnder the conditions of the study, the subject device is not a primary skin sensitizer. | |
| In vitro cytotoxicity in accordancewith ISO 10993-5: Third Edition2009-06 | PassesUnder the conditions of the study, the subject device is not cytotoxic. |
8.0 Based on Assessment of Non-Clinical Performance Data:
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. Powder-Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs made by Syntex Healthcare Products Co., Ltd. met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing:
- Dimension per ASTM D6319-10 (Reapproved 2015) A
-
Tensile strength (Before aging/After aging) and Elongation (Before aging/After aging) per ASTM D6319-10(Reapproved 2015)
{7}------------------------------------------------
-
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)
-
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 substantially equivalent to the predicate glove. So determination of substantial equivalence is not based on an assessment of clinical performance data.
10.0 Substantial Equivalence Comparison:
| Table 5.4 SE compare | ||||
|---|---|---|---|---|
| ---------------------- | -- | -- | -- | -- |
| DeviceCharacteristic | Predicate Device | Proposed Device | Comparison |
|---|---|---|---|
| Product name | Powder-Free Nitrile Examination Gloves(Blue), Tested for Use withChemotherapy Drugs | Disposable Powder Free NitrileExamination Glove, Tested For Use WithChemotherapy Drugs, White ColorDisposable Powder Free NitrileExamination Glove, Tested For Use WithChemotherapy Drugs, Orange Color | N/A |
| 510(K) No. | K182156 | K190860 | N/A |
| Product Owner | Syntex Healthcare Products Co., Ltd | Ever Growth Enterprise Corporation | Different |
| Product Code | LZA, LZC | LZA, LZC | same |
| Regulation | 21 CFR 880.6250 | 21 CFR 880.6250 | same |
| Class | same | ||
| Intended Use | The Nitrile Powder Free ExaminationGlove (Blue) with Low DermatitisPotential Claim is a disposable deviceintended for medical purpose that isworn on the examiner's hands or fingerto prevent contamination betweenpatient and examiner. In addition thesegloves were tested for use withChemotherapy drugs in accordancewith ASTM D6978-05 standards Practicefor assessment of Medical Glove toPermeation by chemotherapy drugs. | A patient examination gloves is adisposable device intended for medicalpurpose that is worn on the examiner'shand or fingers to prevent contaminationbetween patient and examiner. In addition,these gloves were tested for use withchemotherapy drugs in accordance withASTM D6978-05 Standard Practice forAssessment of Medical gloves toPermeation 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 D6319-10230 mm min. | Complies with ASTM D6319-10230 mm min. | same |
| Dimensions | Complies with ASTM D6319-10 | Complies with ASTM D6319-10 | same |
{8}------------------------------------------------
| -Palm Width | X Small | $70\pm10$ | X Small | $70\pm10$ | |
|---|---|---|---|---|---|
| Small | $80\pm10$ | Small | $80\pm10$ | ||
| Medium | $95\pm10$ | Medium | $95\pm10$ | ||
| Large | $110\pm10$ | Large | $110\pm10$ | ||
| X large | $120\pm10$ | X large | $120\pm10$ | ||
| Dimensions-Thickness | Complies with ASTM D6319-10Palm - 0.05 mm min.Finger - 0.05 mm min. | Complies with ASTM D6319-10Palm - 0.05 mm min.Finger - 0.05 mm min. | similar | ||
| 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 | ||
| Freedomfrom Holes | In accordance with ASTM D6319-10 andASTM D5151-06(reapproved 2011), G-1,AQL 2.5 | In accordance with ASTM D6319-10 andASTM D5151-06(reapproved 2011), G-1,AQL 2.5 | similar | ||
| Bio-compatibility | AAMI/ANSI/ISO 10993-10PassesNot a skin irritant & Not a skin sensitizer | AAMI/ANSI/ISO 10993-10Skin sensitization test & Skin Irritationtest: PassesAAMI/ ANSI/ ISO 10993-5In vitro cytotoxicity test: Passes | same | ||
| Chemotherapy drugs tested | Breakthrough Detection Time in Minutes | comparison | |||
| Device Characteristic | Predicate device | Proposed Device | |||
| Blue | White | orange | |||
| Carmustine (BCNU), 3.3 mg/ml | 11.4 | 11.8 | 31.6 | similar | |
| Thiotepa, 10.0 mg/ml | 13.6 | 16.9 | 72.5 | similar | |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 | >240 | >240 | same | |
| Cisplatin, 1.0 mg/ml | >240 | >240 | >240 | same | |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 | >240 | >240 | same | |
| Fluorouracil, 50.0 mg/ml | >240 | >240 | >240 | same | |
| Dacarbazine (DTIC), 10.0 mg/ml | >240 | >240 | >240 | same | |
| Etoposide (Toposar), 20.0 mg/ml | >240 | >240 | >240 | same | |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 | >240 | >240 | same |
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.
§ 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.