(97 days)
A patient examination gloves 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. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
This document is a 510(k) Pre-market Notification for medical gloves, focusing on their resistance to chemotherapy drugs. It details the performance of "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Original Blue, Cobalt Blue)" against a range of chemotherapy agents.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for chemotherapy drug permeation are defined by the "Average Breakthrough Detection Time" for each drug. While the specific numerical acceptance criteria (e.g., minimum time) are not explicitly stated as distinct "criteria" separate from the results, the implication is that the longer the breakthrough time, the better the performance. For many drugs, a breakthrough time of "> 240 minutes" is presented, suggesting this is a desirable outcome or a de facto acceptance benchmark for long-term protection. The device performance is the directly measured average breakthrough detection time for each drug.
Below are the tables summarizing the performance for both "Original Blue" and "Cobalt Blue" glove variations, as tested against various chemotherapy drugs.
Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs - Original Blue
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
|---|---|
| Carboplatin, 10 mg/ml | > 240 |
| Carmustine (3.3 mg/ml) | 1.84 |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 |
| Etoposide (Toposar), 20.0 mg/ml | > 240 |
| Fluorouracil, 50.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Methotrexate, 25 mg/ml | > 240 |
| Mitomycin C, 0.5 mg/ml | > 240 |
| Mitoxantrone, 2 mg/ml | > 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 |
| ThioTEPA (10.0 mg/ml) | 0.76 |
| Vincristine Sulfate, 1.0 mg/ml | > 240 |
| Warning for drugs with extremely low permeation time: | Carmustine (3.3 mg/ml): 1.84 minutes |
| ThioTEPA (10.0 mg/ml): 0.76 minutes |
Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs - Cobalt Blue
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
|---|---|
| Carboplatin, 10 mg/ml | > 240 |
| Carmustine (3.3 mg/ml) | 1.82 |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 |
| Etoposide (Toposar), 20.0 mg/ml | > 240 |
| Fluorouracil, 50.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Methotrexate, 25 mg/ml | > 240 |
| Mitomycin C, 0.5 mg/ml | > 240 |
| Mitoxantrone, 2 mg/ml | > 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 |
| ThioTEPA (10.0 mg/ml) | 0.93 |
| Vincristine Sulfate, 1.0 mg/ml | > 240 |
| Warning for drugs with extremely low permeation time: | Carmustine (3.3 mg/ml): 1.82 minutes |
| ThioTEPA (10.0 mg/ml): 0.93 minutes |
In addition to chemotherapy drug permeation, the gloves were also tested against other specifications, including:
| Characteristic | Standard | Acceptance Criteria | Device Performance (Original Blue) | Device Performance (Cobalt Blue) |
|---|---|---|---|---|
| Dimension | ASTM D6319-10 | Minimum 240mm length | Minimum 240mm | Minimum 240mm |
| Physical Properties | ASTM D6319-10 | Meets standard requirements | Meets | Meets |
| Thickness | ASTM D6319-10 | Finger 0.07-0.10mm (Predicate 1), 0.10min (Predicate 2); Palm 0.07-0.09mm; Cuff 0.06-0.08mm (Predicate 1), Not specified (Cuff, Predicate 2) | Finger 0.09-0.14mm; Palm 0.07-0.10mm; Cuff 0.06-0.09mm | Finger 0.10min; Palm 0.07-0.09mm; Cuff 0.05-0.08mm |
| Powder-free | ASTM D6124-06 (<2mg/glove) | Meets standard requirements (less than 2mg/glove) | Meets | Meets |
| Bio-compatibility | ISO 10993-10 (2010), Consumer Product Safety Commission | Not a primary skin irritant; Not a contact sensitizer | Under the condition of the study the device is non-irritant; Under the condition of the study the device is non-sensitizer | Under the condition of the study the device is non-irritant; Under the condition of the study the device is non-sensitizer |
| Water tightness | ASTM D5151-06 | Passes (1000ml) | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for testing each individual chemotherapy drug permeation or other properties. However, it does state that the device "meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250." These ASTM standards would typically define the appropriate sample sizes and testing methodologies.
The data provenance is not specified, but the submission is from "YTY Industry (Manjung) Sdn. Bhd., Malaysia," suggesting the tests were likely conducted on products manufactured or supervised by this Malaysian entity. The tests appear to be a prospective evaluation of the device's performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes performance testing of physical properties and chemical permeation resistance of gloves, not diagnostic or clinical interpretation. Therefore, the concept of "experts used to establish ground truth" as it would apply to image analysis or clinical diagnosis is not applicable here. The "ground truth" is established by adherence to recognized industrial standards (ASTM D6319-10 and D6978-05) and FDA regulations. These standards define the scientific methods and procedures for evaluating glove performance.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a device (often AI-based) on human reader performance in tasks like diagnostic interpretation. This document pertains to the physical and chemical performance of medical gloves, not assistive diagnostic technology.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Yes, a standalone performance assessment was done. The entire study described is a standalone evaluation of the glove's performance against various physical and chemical challenges, without human-in-the-loop interaction in the context of diagnostic interpretation. The breakthrough detection times and physical properties are direct measurements of the device's inherent characteristics.
7. The Type of Ground Truth Used
The ground truth used is based on established industry standards and scientific testing procedures. Specifically:
- ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: This standard outlines the methodology for determining the breakthrough detection time of chemotherapy drugs through glove material.
- ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application: This standard sets specifications for physical properties like dimensions, physical performance, and powder content.
- ISO 10993-10 (2010) and Consumer Product Safety Commission II, Part 1500: These standards govern biocompatibility testing (primary skin irritation and dermal sensitization).
- ASTM D5151-06: This standard relates to water tightness testing.
The results obtained through these standardized testing methods serve as the "ground truth" for the device's performance.
8. The Sample Size for the Training Set
Not applicable. This device is a medical glove, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, with three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
YTY Industry (Manjung) Sdn. Bhd., Punitha Samy Deputy Manager-DC/RA Lot 1422-1424 Batu 10 Lekir Sitiawan, Perak 32020 MY
Re: K162095
Trade/Device Name: Non-sterile, Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Original Blue, Cobalt Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: September 19, 2016 Received: September 23, 2016
Dear Punitha Samy:
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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
510(k) Number (if known) K162095
Device Name
Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Original Blue
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 finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time |
|---|---|
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine (3.3 mg/ml) | 1.84 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide , 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA (10.0 mg/ml) | 0.76 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 1.84 minutes ThioTEPA (10.0 mg/ml): 0.76 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.
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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."
{4}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162095
Device Name
Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue
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 finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time |
|---|---|
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine (3.3 mg/ml) | 1.82 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide , 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA (10.0 mg/ml) | 0.93 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 1.82 minutes ThioTEPA (10.0 mg/ml): 0.93 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.
{5}------------------------------------------------
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 Druq 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."
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K162095
510 (K) SUMMARY SHEETS
| 1.0 | 510 (K) SUMMARY | ||
|---|---|---|---|
| 2.0 | Submitter | YTY INDUSTRY (MANJUNG) SDN. BHD.,Lot 1422-1424, Batu 10 Lekir32020 Sitiawan, PerakMalaysia | |
| Tel | 605-6908533 | ||
| Fax | 605-6908533 | ||
| Name of Contact Person | Punitha Samy (Ms)E-mail: punitha.samy@ytygroup.com.my | ||
| Date Summary Prepared | November 2, 2016 | ||
| 3.0 | Name of Device | ||
| Trade Name: | Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves,Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) | ||
| Common Name: | Nitrile Examination Gloves | ||
| Classification Name: | Patient Examination Gloves, Powder Free | ||
| Device Classification: | I | ||
| Regulation No. & Classification Name: Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC)Patient Examination Gloves (21 CFR 880.6250 product code LZA) |
Panel:
General Hospital
4.0 Identification of The Legally Marketed Devices that equivalency is claimed:
| Device Name | Dermagrip Powder FreeBlue Nitrile PatientExamination Gloves, Non-Sterile, Tested for use withChemotherapy Drugs | Nitrile Powder FreeExamination Gloves Testedfor Use withChemotherapy Drugs -Violet Blue (VBLU) |
|---|---|---|
| Predicate 510(K)number: | K141982 | K151997 |
| Device Classification: | 1 | 1 |
| Product Code: | LZC | LZC |
Sec 1 Sum Page 1 of 8
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5.0 Description of The Device
Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
6.0 The Intended Use of Glove
A patient examination gloves 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. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
| Characteristic | Concentration | K162095Original Blue | K162095Cobalt Blue |
|---|---|---|---|
| Average Breakthrough Detection Time (minutes) | |||
| Carboplatin | 10mg/ml | > 240 | > 240 |
| *Carmustine | 3.3mg/ml | 1.84 | 1.82 |
| Cisplatin (BCNU) | 1.0mg/ml | > 240 | > 240 |
| Cyclophosphamide(Cytoxan) | 20.0mg/ml | > 240 | > 240 |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 | > 240 |
| DoxorubicinHydrochloride | 2.0mg/ml | > 240 | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 | > 240 |
| Methotrexate | 25mg/ml | > 240 | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 | > 240 |
| Mitoxantrone | 2 mg/ml | > 240 | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 |
| Thiotepa | 10.0mg/ml | 0.76 | 0.93 |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 |
| Warning Statement | *WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 1.84 minutes and ThioTepa: 0.76 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA | * WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 1.82 minutes and ThioTepa: 0.93 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA |
Sec 1 Sum Page 2 of 8
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7.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for substantial equivalent discussion
There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) have the below technological characteristic compared to ASTM or Equivalent standards.
This glove is compliant with the ASTM standards and similar to the predicate device in the market, which has a glove thickness less than 0.10mm and length less than 270mm. The chemotherapy claim is similar to Predicate.
| Table 1 – Predicate 1 | ||
|---|---|---|
| Characteristic | Standards | Device Performance |
| Predicate K162095 – Original Blue | ||
| 510(K) Number | K141982 K162095 | |
| Dimension | ASTM D6319-10 | Min 240mm Min 240mm |
| Physical Properties | ASTM D6319-10 | Meets Meets |
| Thickness | ASTM D6319-10 | Finger 0.07 – 0.10mm 0.09 – 0.14mmPalm 0.07 – 0.09mm 0.07 - 0.10mmCuff 0.06 – 0.08mm 0.06 – 0.09mm |
| Powder-free | ASTM D6124-06(<2mg/glove) | Meets Meets |
| Bio-compatibility | Primary skinirritationISO 10993-10 (2010)Dermal SensitizationISO 10993-10 (2010) | Not a primary skin irritantunder the conditions ofthe study Under the condition ofthe study the device isnon-irritantNot a contact sensitizerunder the conditions ofthe study Under the condition ofthe study the device isnon-sensitizer |
| Table 1 - Predicate 1 | ||
|---|---|---|
| -- | ----------------------- | -- |
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| Characteristic | Tested accordingto ASTM D6978-05 | Device Performance | |
|---|---|---|---|
| Concentration | Predicate-K141982 | K162095– Original Blue | |
| Average Breakthrough Detection Time (minutes) | |||
| Carboplatin | 10mg/ml | - | > 240 |
| *Carmustine | 3.3mg/ml | 15 | 1.84 |
| Cisplatin | 1.0mg/ml | > 240 | > 240 |
| Cyclophosphamide(Cytoxan) | 20.0mg/ml | > 240 | > 240 |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 | > 240 |
| DoxorubicinHydrochloride | 2.0mg/ml | > 240 | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 | > 240 |
| Ifosfamide (Ifex) | 50.0mg/ml | > 240 | > 240 |
| Methotrexate | 25mg/ml | - | > 240 |
| Mitomycin C | 0.5mg/ml | - | > 240 |
| Mitoxantrone | 2 mg/ml | > 240 | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 |
| Thiotepa | 10.0mg/ml | 2.0 | 0.76 |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 |
| Warning Statement | *WARNING: Please note thatthe following drugs haveextremely low permeationtimes: Carmustine (BCNU) :15 minutes and Thiotepa : 2minutes | *WARNING: Please note thatthe following drugs haveextremely low permeationtimes: Carmustine: 1.84minutes and ThioTepa: 0.76minutes. NOT TO BE USEDWITH CARMUSTINE ORTHIOTEPA |
Table 2 – Predicate 1
Table 3 – Predicate 2
| Characteristic | Standards | Device Performance | |
|---|---|---|---|
| Predicate | K162095 – Cobalt Blue | ||
| 510(K) Number | K151997 | K162095 | |
| Dimension | ASTM D6319-10 | Min 240mm | Min 240mm |
| Physical Properties | ASTM D6319-10 | Meets | Meets |
| Thickness | Finger | 0.10min | 0.10min |
| Palm | 0.07 – 0.09mm | 0.07 – 0.09mm | |
| Cuff | 0.05 - 0.08mm | ||
| Powder-free | ASTM D6124-06(< 2mg/glove) | Meets | Meets |
| Bio-compatibility | Primary skinirritationISO 10993-10(2010) | Not a primary skin irritant underthe conditions of the study | Under the condition of thestudy the device is non-irritant |
| DermalSensitizationISO 10993-10(2010) | Not a contact sensitizer underthe conditions of the study | Under the condition of thestudy the device is non-sensitizer |
Sec 1 Sum Page 4 of 8
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| Table 4 - Predicate 2 | |||
|---|---|---|---|
| Characteristic | Tested according toASTM D6978-05 | Device Performance | |
| Predicate - K151997 | K162095 – Cobalt Blue | ||
| Average Breakthrough Detection Time (minutes) | |||
| Concentration | Predicate | Current | |
| Carboplatin | 10mg/ml | - | > 240 |
| *Carmustine | 3.3mg/ml | 10.2 | 1.82 |
| Cisplatin | 1.0mg/ml | > 240 | > 240 |
| Cyclophosphamide(Cytoxan) | 20.0mg/ml | > 240 | > 240 |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 | > 240 |
| DoxorubicinHydrochloride | 2.0mg/ml | > 240 | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 | > 240 |
| Ifosfamide (Ifex) | 50.0mg/ml | - | > 240 |
| Methotrexate | 25mg/ml | > 240 | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 | > 240 |
| Mitoxantrone | 2 mg/ml | - | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 |
| Thiotepa | 10.0mg/ml | 30.2 | 0.93 |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 |
| Warning Statement | * Please note thatCarmustine and Thiotepahave extremely lowpermeation times of 10.2minutes and 30.2minutes | * WARNING: Please note thatthe following drugs haveextremely low permeationtimes: Carmustine: 1.82minutes and ThioTepa: 0.93minutes. NOT TO BE USEDWITH CARMUSTINE ORTHIOTEPA |
Table 4 – Predicate 2
Sec 1 SUM Page 5 of 8
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| Table 5 Device Performance | |||||
|---|---|---|---|---|---|
| Characteristics | PredicateK141982 | K162095Original Blue | PredicateK151997 | K162095Cobalt Blue | Medical GloveManual (1661) andStandards |
| Water tightness(1000ml) | Passes | Passes | Passes | Passes | ASTM D5151-06 |
| Color | Blue | Original Blue | Violet Blue | Cobalt Blue | ASTM D6319-10(Reapproved 2015) |
| Material | Nitrile | Nitrile | Nitrile | Nitrile | Labeling |
| Size | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Labeling |
| Texture | Finger Textured | Finger Textured | FingerTextured | FingerTextured | |
| Single Use | Single Use | Single Use | Single Use | Single Use | Labeling |
| Bio-compatibility | Passes | Passes | Passes | Passes | Primary Skin Irritation |
| Not primary skinirritant under theconditions of the study. | Under the condition of thestudy the device is non-irritant | Under the condition ofthe study the device isnon-irritant | Under the condition of thestudy the device is non-irritant | ISO 10993-10: 2010(E)Test for Irritation andSkin Sensitization &Consumer ProductSafety Commission II,Part 1500 | |
| PassesNot a contact sensitizerunder the conditions ofthe study. | PassesUnder the condition of thestudy the device in non-sensitizer | PassesUnder the condition ofthe study the device innon-sensitizer | PassesUnder the condition of thestudy the device in non-sensitizer | Dermal Sensitization -ISO 10993-10(E) &Consumer ProductSafety Commission,Title 16, Chapter II,Part 1500.3 (c) (4) |
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| Indications for Use | A patientExamination glove is amedical device intendedfor medical purposesthat is worn on theexaminer's hand toprevent contaminationbetween patient andexaminer. | A patient examination gloves is adisposable device intended formedical purpose that is worn on theexaminer's hand or finger toprevent contamination betweenpatient and examiner. This glove isalso tested for use againstChemotherapyDrugs. The Chemotherapy Drugsand its permeation time is listed asbelow. | Is nonsteriledisposable deviceintended for medicalpurpose that is worn onthe examiner's hand toprevent contaminationbetween patient andexaminer. It is alsotested to be used againstChemotherapy Drugs. | A patient examination gloves is adisposable device intended formedical purpose that is worn on theexaminer's hand orfinger to prevent contaminationbetween patient and examiner. Thisglove is also tested for use againstChemotherapyDrugs. The Chemotherapy Drugsand its permeation time is listed asbelow. | This gloves meet allcurrent specificationslisted under ASTMspecifications D6319-10 |
|---|---|---|---|---|---|
| *Carmustine3.3mg/ml15Cisplatin 1.0mg/ml >240CyclophosphamideCytoxan) 20.0mg/ml > | Tested ChemotherapyDrug And Concentration | Carmustine (3.3 mg/ml)10.2 minutesCisplatin (1.0 mg/ml) >240minutesCyclophosphamide (20mg/ml) >240 minutesDacarbazine (10.0 mglml)>240 minutesDoxorubicinHydrochloride (2.0 mg/ml)>240 minutesEtoposide (20.0 mg/ml)>240 minutes | Tested ChemotherapyDrug And Concentration | ||
| 240Dacarbazine (DTIC)10.0mg/ml> 240DoxorubicinHydrochloride 2.0mg/ml>240Etoposide (Toposar)20.0mg/ml> 240 | Carboplatin, 10 mg/mlCarmustine (3.3 mg/ml)Cisplatin (BCNU), 1.0mg/mlCyclophosphamide(Cytoxan), 20.0 mg/mlDacarbazine (DTIC), 10.0mg/ml | Fluorouracil (50.0 mg/ml)Methotrexate (25 mg/ml) | Carboplatin, 10mg/mlCarmustine (3.3 mg/ml)Cisplatin (BCNU), 1.0mg/mlCyclophosphamide(Cytoxan), 20.0 mg/mlDacarbazine (DTIC), 10.0mg/ml | ||
| Fluorouracil 50.0mg/ml>240Ifosfamide (Ifex)50.0mg/ml> 240 | DoxorubicinHydrochloride, 2.0 mg/mlEtoposide (Toposar), 20.0mg/ml | DoxorubicinHydrochloride, 2.0 mg/mlEtoposide (Toposar), 20.0mg/ml | |||
| Mitoxantrone 2 mg/ml>240Paclitaxel (Taxol)6.0mg/ml> 240Thiotepa 10.0mg/ml 2.0 | Fluorouracil, 50.0 mg/mlIfosfamide , 50.0 mg/mlMethotrexate, 25 mg/mlMitomycin C, 0.5 mg/mlMitoxantrone, 2 mg/ml | Mitomycin C (0.5 mg/ml)>240 minutesPaclitaxel (6.0 mg/ml)>240 minutesThiotepa (10.0 mg/ml)30.2 minutesVincristine Sulfate (1.0mg/ml) >240 minutesPlease note thatCarmustine and Thiotepahave extremely low | Fluorouracil, 50.0 mg/mlIfosfamide , 50.0 mg/mlMethotrexate, 25 mg/mlMitomycin C, 0.5 mg/mlMitoxantrone, 2 mg/ml | ||
| Vincristine Sulfate1.0mg/ml> 240Warning Statement | Paclitaxel (Taxol), 6.0mg/mlThioTEPA (10.0 mg/ml)Vincristine Sulfate, 1.0 | Paclitaxel (Taxol), 6.0mg/mlThioTEPA (10.0 mg/ml) | |||
| *WARNING: Please notethat the following drugshave extremely low | mg/mlThe following chemotherapy drugs and | mg/mlThe following chemotherapy drugs and | |||
| permeation times:Carmustine (BCNU) : 15minutes and Thiotepa : 2minutes | concentration have extremely lowpermeation time.Carmustine (3.3 mg/ml): 1.84 minThioTEPA (10.0 mg/ml): 0.76 min | concentration have extremely lowpermeation time.Carmustine (3.3 mg/ml): 1.82 minThioTEPA (10.0 mg/ml): 0.93 min | |||
| AverageBreakthroughDetectionTime | AverageBreakthroughDetectionTime | ||||
| >240 min | >240 min | ||||
| 1.84 min | 1.82 min | ||||
| >240 min | >240 min | ||||
| >240 min | >240 min | ||||
| >240 min | >240 min | ||||
| >240 min | >240 min | ||||
| >240 min | >240 min | ||||
| >240 min | >240 min | ||||
| >240 min | >240 min | ||||
| >240 min | >240 min | ||||
| >240 min | >240 min | ||||
| 0.76 min | 0.93 min | ||||
| >240 min | >240 min |
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8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
The non-clinical tests performance data support a determination of substantial equivalence is the same as and in compliance to ASTM requirements.
9.0 Conclusion
The conclusions drawn from the intended uses, technological characteristics and non-clinical tests demonstrate that the subject device is substantially equivalent to the predicate device K141982 and K151997.
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§ 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.