(307 days)
A powder-free patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand 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.
KS Medicare Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, meeting all the requirement of ASTM standards D6319-10 (Reapproved 2015), ASTM D6978-05 and ASTM D6124-06 (Reaffirmation 2011).
Principle of operation: KS Medicare Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, are non-sterile single use only, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between the patient and examiner. This powder free nitrile examination glove is manufactured from synthetic rubber. A process known as chlorination has been incorporated in the manufacturing of the gloves that don easily for the user without the addition of powder. Chlorination is a process wherein examination gloves are exposed to chlorine gas or a hypochloritehydrochloric acid mixture in order to harden the surface of the glove. The hardening of the glove surface decreases the surface friction of the glove thereby allowing for gloves to be easily donned without powder.
The gloves are ambidextrous and offered in three sizes: small, medium, and large.
This document is a 510(k) premarket notification for KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black). It aims to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs, K161422).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The primary acceptance criteria for the "Tested for Use with Chemotherapy Drugs" claim are the minimum breakthrough detection times for various chemotherapy drugs, as determined by ASTM D6978-05. The device must meet or exceed the performance of the predicate device.
Table of Acceptance Criteria (from Predicate Device K161422 – Blue glove, as reported for the Proposed Device comparison in Table 3 and Table 6) and Reported Device Performance for the Proposed Device (Blue and Black gloves):
| Test Chemotherapy Drug and Concentration | Predicate Device Breakthrough Detection Time (Minutes) (Acceptance Criteria) | Proposed Device (Blue) Breakthrough Detection Time (Minutes) (Reported Performance) | Proposed Device (Black) Breakthrough Detection Time (Minutes) (Reported Performance) |
|---|---|---|---|
| Carmustine (BCNU), 3.3 mg/ml | 15.0 | 14.8 | 22.6 |
| Cisplatin, 1.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Etoposide (Toposar), 20.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Fluorouracil, 50.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Methotrexate, 25 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 | ≥ 240 | ≥ 240 |
| Thiotepa, 10.0 mg/ml | 2.0 (Implicit, as predicate's performance is 2.0 for reference) | 35.2 | 14.0 |
Additional Acceptance Criteria (based on ASTM D6319-10 (Reapproved 2015), ASTM D6978-05, ASTM D6124-06 (Reaffirmation 2011), ASTM D5151-06, and 21CFR 800.20):
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material | Nitrile | Nitrile |
| Dimensions - Length | Meets ASTM D6319-10 (Predicate: Min. 240mm) | Proposed Device: Min. 230mm (Similar to predicate) |
| Dimensions - Width | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Dimensions - Thickness | Meets ASTM D6319-10 (Predicate: Finger 0.07-0.10mm, Palm 0.07-0.09mm) | Proposed Device: Finger Min. 0.08mm, Palm Min. 0.07mm (Similar to predicate) |
| Physical Properties - Tensile | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Physical Properties - Elongation | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Freedom from Holes | Meets ASTM D5151-06 and 21CFR 800.20 | Meets ASTM D5151-06 and 21CFR 800.20 |
| Residual Powder | Meets Powder level requirements for "Powder Free" per ASTM D6319-10 tested using ASTM D6124-06 | Meets Powder level requirements for "Powder Free" per ASTM D6319-10 tested using ASTM D6124-06 |
| Biocompatibility | Passes tests for: Primary Skin Irritation, Dermal Sensitization | Passes tests for: Primary Skin Irritation, Dermal Sensitization |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests. The document states:
"The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements)." and "It was our conclusion that KS Medicare Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs tested met all relevant requirements of the aforementioned tests."
Specifically for chemotherapy drug permeation, the gloves underwent testing in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
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 primarily describes a conformity assessment against established ASTM standards. For the chemotherapy drug permeation test (ASTM D6978-05), the number of samples used is not explicitly stated in this summary. ASTM standards typically specify minimum sample sizes for such tests. Similarly, the specific provenance (country of origin, retrospective/prospective) of the data for these performance tests is not detailed beyond the manufacturer being in Malaysia. However, compliance with ASTM standards implies a standardized testing methodology.
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 physical product (gloves) and not an AI or diagnostic device that requires expert ground truth for interpretation. The "ground truth" for the performance tests consists of the standardized methodologies and results defined by the relevant ASTM standards. Experts would be involved in conducting these tests according to the standards and interpreting the raw data to determine if the criteria are met, but their number and specific qualifications are not typically detailed in this type of 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human interpretation that would require an adjudication method.
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 product is a medical glove, not an AI or diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This product 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 established by the well-defined, objective experimental procedures and measurement criteria outlined in the referenced ASTM standards (e.g., ASTM D6978-05 for chemotherapy drug permeation, ASTM D6319-10 for dimensions and physical properties, ASTM D5151-06 for freedom from holes, ASTM D6124-06 for residual powder, and biocompatibility testing standards).
8. The sample size for the training set
Not applicable. This is a physical product, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical product and does not have a "training set" in the context of an AI algorithm.
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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, there 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.
February 22, 2018
Koon Seng Sdn. Bhd. % Jigar Shah Official Correspondent MDI Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck. New York 11021
Re: K171171
Trade/Device Name: KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: January 10, 2018 Received: January 11, 2018
Dear Jigar Shah:
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. 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K171171
Device Name
KS Medicare Powder Free Examination Gloves, Non-sterile, Tested for use with Chemotherapy Drugs (Black)
Indications for Use (Describe)
A powder-free patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand 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:
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection time in Minutes |
|---|---|
| 1. Carmustine (BCNU), 3.3 mg/ml | 22.6 |
| 2. Cisplatin, 1.0 mg/ml | ≥ 240 |
| 3. Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| 4. Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| 5. Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| 6. Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| 7. Fluorouracil, 50.0 mg/ml | ≥ 240 |
| 8. Methotrexate, 25 mg/ml | ≥ 240 |
| 9. Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
| 10. Thiotepa, 10.0 mg/ml | 14.0 |
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 22.6 minutes Thiotepa, 10.0 mg/ml 14.0 minutes
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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 FDA 3881 (8/14)
{3}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K171171
Device Name
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for use with Chemotherapy Drugs (Blue)
Indications for Use (Describe)
A powder-free 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.
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 in Minutes |
|---|---|
| 1. Carmustine (BCNU), 3.3 mg/ml | 14.8 |
| 2. Cisplatin, 1.0 mg/ml | ≥ 240 |
| 3. Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| 4. Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| 5. Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| 6. Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| 7. Fluorouracil, 50.0 mg/ml | ≥ 240 |
| 8. Methotrexate, 25 mg/ml | ≥ 240 |
| 9. Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
| 10. Thiotepa, 10.0 mg/ml | 35.2 |
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 14.8 minutes Thiotepa, 10.0 mg/ml 35.2 minutes
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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 FDA 3881 (8/14)
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510(k) SUMMARY
The assigned 510(k) number is: K171171
1. Submitter's Identification:
Applicant:
Name: Koon Seng Sdn. Bhd. Address: PTD 16058, Kawasan Perindustrian Tangkak, Jalan Muar, 84900 Tangkak, Johor, Malaysia
Submitter:
Mr. Jigar Shah Name: Official Correspondent for Koon Seng Sdn. Bhd. Address: mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Date Summary Prepared: January 9,
2018 Contact: Mr. Jiqar Shah 516-482-9001 Office: Fax: 516-482-0186 jigar@mdiconsultants.com Email:
2. Name of the Device:
Device Name: KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested For Use with Chemotherapy Drugs (Blue, Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC
3. Information for the 510(k) Cleared Device (Predicate Device):
Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs previously cleared under 510(k) K161422 (product code LZA, LZC)
4. Device Description:
KS Medicare Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, meeting all the requirement of ASTM standards D6319-10 (Reapproved 2015), ASTM D6978-05 and ASTM D6124-06 (Reaffirmation 2011).
Principle of operation: KS Medicare Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, are non-sterile single use only, disposable gloves intended for medical purposes to be worn on the hands of
{5}------------------------------------------------
examiners to prevent contamination between the patient and examiner. This powder free nitrile examination glove is manufactured from synthetic rubber. A process known as chlorination has been incorporated in the manufacturing of the gloves that don easily for the user without the addition of powder. Chlorination is a process wherein examination gloves are exposed to chlorine gas or a hypochloritehydrochloric acid mixture in order to harden the surface of the glove. The hardening of the glove surface decreases the surface friction of the glove thereby allowing for gloves to be easily donned without powder.
The gloves are ambidextrous and offered in three sizes: small, medium, and large. Attached please refer to following:
-
- Device Drawing
-
- Device Photos (Black and Blue)
-
- Device Specifications (Black and Blue)
5. Indications for Use:
KS Medicare Powder Free Examination Gloves. Non-sterile. Tested for use with Chemotherapy Drugs (Black):
A powder-free 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.
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 andConcentration | MinimumBreakthroughDetectionTime inMinutes | |
|---|---|---|
| 1. | Carmustine (BCNU), 3.3 mg/ml | 22.6 |
| 2. | Cisplatin, 1.0 mg/ml | ≥ 240 |
| 3. | Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| 4. | Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| 5. | Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| 6. | Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| 7. | Fluorouracil, 50.0 mg/ml | ≥ 240 |
| 8. | Methotrexate, 25 mg/ml | ≥ 240 |
| 9. | Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
| 10 | Thiotepa, 10.0 mg/ml | 14.0 |
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 | 22.6 minutes |
|---|---|
| Thiotepa, 10.0 mg/ml | 14.0 minutes |
{6}------------------------------------------------
KS Medicare Powder Free Examination Gloves. Non-sterile. Tested for use with Chemotherapy Drugs (Blue):
A powder-free 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.
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 andConcentration | MinimumBreakthroughDetectionTime inMinutes | |
|---|---|---|
| 1. | Carmustine (BCNU), 3.3 mg/ml | 14.8 |
| 2. | Cisplatin, 1.0 mg/ml | ≥ 240 |
| 3. | Cyclophosphamide (Cytoxan), 20.0 mg/ml | ≥ 240 |
| 4. | Dacarbazine (DTIC), 10.0 mg/ml | ≥ 240 |
| 5. | Doxorubicin Hydrochloride, 2.0 mg/ml | ≥ 240 |
| 6. | Etoposide (Toposar), 20.0 mg/ml | ≥ 240 |
| 7. | Fluorouracil, 50.0 mg/ml | ≥ 240 |
| 8. | Methotrexate, 25 mg/ml | ≥ 240 |
| 9. | Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
| 10 | Thiotepa, 10.0 mg/ml | 35.2 |
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 | 14.8 minutes |
|---|---|
| Thiotepa, 10.0 mg/ml | 35.2 minutes |
6. Comparison to the 510(k) Cleared Devices (Predicate Devices):
Table 1: Proposed Device (Blue) compares Predicate Device
| Device Characteristic | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Product Name | KS Medicare Powder -FreeNitrile Examination GlovesTested for Use withChemotherapy Drugs | Dermagrip Powder Free BlueNitrile Examination Gloves,Non-sterile, Tested for usewith Chemotherapy Drugs | |
| 510(K) Reference | K171171 | K161422 | |
| Product Owner | Koon Seng Sdn. Bhd. | WRP Asia Pacific Sdn. Bhd. | |
| Product Code | LZA, LZC | LZA, LZC | Same |
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| Device Characteristic | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Indication For Use | A powder-free patientexamination glove isa disposable deviceintended for medicalpurposes that is wornon the examiner's handor finger to preventcontamination betweenpatient and examiner.In addition, these gloveswere tested for use withchemotherapy drugs inaccordance with ASTMD6978-05 StandardPractice for Assessmentof Medical gloves to | A patient examination gloveis a disposable deviceintended for medicalpurposes that isworn on the examiner's hand ofinger to preventcontamination between patientand examiner. These gloveswere tested for use withChemotherapy Drugs as perASTM D6978-05Standard Practice forAssessment of MedicalGloves to Permeation byChemotherapy Drugs:Chemotherapy DrugPermeation The following | Same |
| Permeation byChemotherapy Drugs: | chemicals have been testedwith these gloves: | ||
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Design Configuration | Ambidextrous; Inner GloveSurface Chlorine Treated tofacilitate Donning; FingertipsTextured to Improve Tactilityand Grip | Inner surface of gloves undergoessurface treatment process to producea smooth surface that assists theuser in donning the gloves with easewithout using any lubricant such aspowder on the glove surface. Theglove is ambidextrous | Similar |
| Dimensions - Length | Meets ASTM D6319-10Min.: 230mm | Meets ASTM D6319-10Min.: 240mm | Similar |
| Dimensions - Width | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same |
| Dimensions-Thickness | Meets ASTM D6319-10Finger: Min. 0.08mmPalm: Min. 0.07mm | Meets ASTM D6319-10Finger: 0.07 -0.10mm Palm: 0.07 – | Similar |
| Physical Properties -Tensile | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same |
| Physical Properties -Elongation | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same |
| Freedom from Holes | Meets ASTM D5151-06and 21CFR 800.20 | Meets ASTM D5151-06and 21CFR 800.20 | Same |
| Residual Powder | Meets Powder levelrequirements for "PowderFree" per ASTM D6319-10tested using ASTMD6124-06 | Meets Powder level requirementsfor "Powder Free" per ASTMD6319-10 tested usingASTM D6124-06 | Same |
| Biocompatibility | Passes tests for:-Primary Skin Irritation-Dermal Sensitization | Passes tests for:-Primary Skin Irritation-Dermal Sensitization | Same |
| Prescription vs. OTC | OTC | OTC | Same |
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| Sterile vs. Non-Sterile | Non-Sterile | Non-Sterile | Same |
|---|---|---|---|
| Single Use vs. | Single Use | Single Use | Same |
| Tested for Use withChemotherapy Drugs | Meets ASTM D6978-05 | Meets ASTM D6978-05 | Same |
Table 3: Proposed Device (Blue) Compares Predicate Device
| Device Characteristic | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Chemotherapy DrugsTested | Breakthrough Detection Time in Minutes | ||
| Fluorouracil (Adrucil)– 50.0 mg/ml | ≥ 240 | ≥ 240 | Similar |
| Etopside (Toposar)– 20.0 mg/ml | ≥ 240 | ≥ 240 | |
| Cyclophosphamide(Cytoxan)– 20.0 mg/ml | ≥ 240 | ≥ 240 | |
| Carmustine (BCNU)– 3.3 mg/ml | 14.8 | 15.0 | |
| Thiotepa– 10.0 mg/ml | 35.2 | 2.0 | |
| Paclitaxel (Taxol)– 6.0 mg/ml | ≥ 240 | ≥ 240 | |
| DoxorubicinHydrochloride(Adriamycin)– 2.0 mg/ml | ≥ 240 | ≥ 240 | |
| Dacarbazine– 10.0 mg/ml | ≥ 240 | ≥ 240 | |
| Cisplatin– 1.0 mg/ml | ≥ 240 | ≥ 240 | |
| I fosfamide– 50.0 mg/ml | - | ≥ 240 | |
| Mitoxantrone– 2.0 mg/ml | - | ≥ 240 | |
| Vincristine Sulfate– 1.0 mg/ml | - | ≥ 240 | |
| Methotrexate– 25 mg/ml | ≥ 240 | ≥ 240 | |
| Mitomycin C– 0.5 mg/ml | - | ≥ 240 |
{9}------------------------------------------------
Table 4: Proposed Device (Black) compares Predicate Device
| Device Characteristic | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Product Name | KS Medicare Powder -FreeNitrile Examination GlovesTested for Use withChemotherapy Drugs | Dermagrip Powder Free BlueNitrile Examination Gloves,Non-sterile, Tested for usewith Chemotherapy Drugs | |
| 510(K) Reference | K161422 | ||
| Product Owner | Koon Seng Sdn. Bhd. | WRP Asia Pacific Sdn. Bhd. | |
| Product Code | LZA, LZC | LZA, LZC | Same |
Table 5: Proposed Device (Black) Compares Predicate Device
| Device Characteristic | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Intended Use | Worn on the hand formedical purposes to providea barrieragainst potential infectionsand other contaminants. Inadditionthese gloves are worn to | Worn on the hand for medicalpurposes to provide a barrieragainst potential infections andother contaminants. In additionthese gloves are worn to protectwearer against exposure tochemotherapy drugs | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Black | Blue | Different |
| Design Configuration | Ambidextrous; Inner GloveSurface Chlorine Treated tofacilitate Donning; FingertipsTextured to Improve Tactilityand Grip | Inner surface of glovesundergoes surface treatmentprocess to produce a smoothsurface that assists the user indonning the gloves with easewithout using any lubricant suchas powder on the glove surface.The glove is ambidextrous. | Similar |
| Dimensions - Length | Meets ASTM D6319-10Min.: 230mm | Meets ASTM D6319-10Min.: 240mm | Similar |
| Dimensions - Width | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same |
| Dimensions-Thickness | Meets ASTM D6319-10Finger: Min. 0.08mmPalm: Min. 0.07mm | Meets ASTM D6319-10Finger: 0.07 – 0.10mmPalm: 0.07 - 0.09mm | Similar |
| Physical Properties -Tensile | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same |
| Physical Properties -Elongation | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same |
| Freedom from Holes | Meets ASTM D5151-06and | Meets ASTM D5151-06 and21CFR 800.20 | Same |
| Residual Powder | Meets Powder levelrequirements for "PowderFree" per ASTM D6319-10tested using ASTMD6124-06 | Meets Powder levelrequirements for "PowderFree" per ASTM D6319-10tested using ASTMD6124-06 | Same |
| Biocompatibility | Passes tests for:-Primary Skin Irritation-Dermal Sensitization | Passes tests for:-Primary Skin Irritation-Dermal Sensitization | Same |
| Prescription vs. OTC | OTC | OTC | Same |
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| Sterile vs. Non-Sterile | Non-Sterile | Non-Sterile | Same |
|---|---|---|---|
| Single Use vs. Reusable | Single Use | Single Use | Same |
| Tested for Use withChemotherapy Drugs | Meets ASTM D6978-05 | Meets ASTM D6978-05 | Same |
Table 6: Proposed Device (Black) Compares Predicate Device
| Device Characteristic | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Chemotherapy DrugsTested | Breakthrough Detection Time in Minutes | ||
| Fluorouracil (Adrucil)– 50.0 mg/ml | ≥ 240 | ≥ 240 | Similar |
| Etopside (Toposar)– 20.0 mg/ml | ≥ 240 | ≥ 240 | |
| Cyclophosphamide(Cytoxan)– 20.0 mg/ml | ≥ 240 | ≥ 240 | |
| Carmustine (BCNU)– 3.3 mg/ml | 22.6 | 15.0 | |
| Thiotepa– 10.0 mg/ml | 14.0 | 2.0 | |
| Paclitaxel (Taxol)– 6.0 mg/ml | ≥ 240 | ≥ 240 | |
| DoxorubicinHydrochloride(Adriamycin)– 2.0 mg/ml | ≥ 240 | ≥ 240 | |
| Dacarbazine– 10.0 mg/ml | ≥ 240 | ≥ 240 | |
| Cisplatin– 1.0 mg/ml | ≥ 240 | ≥ 240 | |
| I fosfamide– 50.0 mg/ml | - | ≥ 240 | |
| Mitoxantrone– 2.0 mg/ml | - | ≥ 240 | |
| Vincristine Sulfate– 1.0 mg/ml | - | ≥ 240 | |
| Methotrexate– 25 mg/ml | ≥ 240 | ≥ 240 | |
| Mitomycin C– 0.5 mg/ml | - | ≥ 240 |
Summary of Technological to Predicate Device – The subject device differs from the predicate:
Difference in Colorant: Koon Seng Sdn. Bhd. medical grade colorant into the subject
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device. The subject device has been tested and shown to function as an effective barrier to chemotherapeutic agents. The subject device has also passed biocompatibility tests for skin irritation and dermal sensitization; the subject gloves are non-toxic and may safely contact either users or patients.
1. Discussion of Non-Clinical Test:
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).
The device and the predicate share the same intended use, same material, same compliance with standards for dimension, physical properties, powder free, biocompatibility, water tightness and tested using ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
It was our conclusion that KS Medicare Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs tested met all relevant requirements of the aforementioned tests.
2. Discussion of Clinical Tests Performed:
No clinical data is required.
3. Conclusions:
KS Medicare Powder- Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Black)" produced by Koon Seng Sdn. Bhd. are as safe and as effective as the 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.