(211 days)
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs.
The proposed devices are Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim. The gloves are available in two colors: blue and white. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document is a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White)" and "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue)". This document is for a medical device (gloves) and not for an AI/ML-driven medical device or software. Therefore, the questions related to AI/ML device testing (such as sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to the content provided.
However, I can extract the acceptance criteria and the study results for the glove's performance as presented in the document, especially regarding its resistance to chemotherapy drugs and other physical properties.
Here's the information based on the provided document, addressing the relevant points and indicating "N/A" for those that do not apply to this type of device:
Device Description: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the gloves are primarily based on ASTM standards and comparisons to a predicate device (K141982). The key performance characteristic tested for this submission is the "Breakthrough Detection Time" for various chemotherapy drugs, which reflects the glove's ability to protect against exposure.
Acceptance Criteria & Device Performance Comparison (Current Device vs. Standards/Predicate)
| Characteristic | Standard / Predicate Acceptance Criteria (Predicate 1: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves Tested for Use with Chemotherapy Drugs, K141982) | Current Device Performance (White Gloves) | Current Device Performance (Blue Gloves) |
|---|---|---|---|
| Physical Properties | |||
| Length | Min 240mm (ASTM D6319-10(2015)) | Min 240mm | Min 240mm |
| Width (medium glove) | Min 85 mm (ASTM D6319-10(2015)) | Min 85 mm | Min 85 mm |
| Tensile Strength (before aging) | Meets min 14Mpa (ASTM D6319-10(2015)) | Meets min 14Mpa | Meets min 14Mpa |
| Tensile Strength (after aging) | Meets min 14Mpa (ASTM D6319-10(2015)) | Meets min 14Mpa | Meets min 14Mpa |
| Elongation (before aging) | Meets min 500% (ASTM D6319-10(2015)) | Meets min 500% | Meets min 500% |
| Elongation (after aging) | Meets min 400% (ASTM D6319-10(2015)) | Meets min 400% | Meets min 400% |
| Thickness – Finger | Meets min 0.05 mm (ASTM D6319-10(2015)) | Meets min 0.05 mm | Meets min 0.05 mm |
| Thickness – Palm | Meets min 0.05 mm (ASTM D6319-10(2015)) | Meets min 0.05 mm | Meets min 0.05 mm |
| Powder Content | ≤ 2 mg/glove (ASTM D6124-06(2011)) | Meets | Meets |
| Watertight (1000ml) | Passes (21 CFR 800.20, ASTM D5151) | Passes | Passes |
| Biocompatibility | |||
| Primary Skin Irritation | Non-irritating (ISO 10993-10:2010) | Non-irritating | Non-irritating |
| Dermal Sensitization | Non-sensitizing (ISO 10993-10:2010) | Non-sensitizing | Non-sensitizing |
| Chemotherapy Drug Permeation Test (ASTM D6978-05) | Predicate Breakthrough Detection Time (min) | Current Device White Gloves Breakthrough Detection Time (min) | Current Device Blue Gloves Breakthrough Detection Time (min) |
| Cisplatin, 1.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Cyclophosphamide, 20.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Doxorubicin HCl, 2.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Etoposide (Toposar), 20.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Fluorouracil, 50.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 | ≥ 240 | ≥ 240 |
| Ifosfamide, 50.0 mg/ml | >240 (Predicate only, current device not tested for this) | N/A | N/A |
| Mitoxantrone, 2.0 mg/ml | >240 (Predicate only, current device not tested for this) | N/A | N/A |
| Vincristine Sulfate, 1.0 mg/ml | >240 (Predicate only, current device not tested for this) | N/A | N/A |
| Carmustine (BCNU) 3.3mg/ml | 15.0 | 24.0 | 18.2 |
| Thiotepa 10.0 mg/ml | 2.0 | 54.9 | 57.3 |
| Warning Statement | Identical warning regarding low permeation times for Carmustine and Thiotepa. | Identical warning, updated times based on testing. | Identical warning, updated times based on testing. |
Note: For Carmustine and Thiotepa, while the breakthrough times might seem low, the predicate also had low times (Thiotepa as low as 2 minutes). The current device shows improved or comparable performance for these challenging drugs, and the critical acceptance criterion is that the warning statement regarding these drugs' properties is present and updated to reflect the tested performance.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for each specific test (e.g., number of gloves tested for chemotherapy permeation or physical properties). However, the testing would have been conducted in accordance with the cited ASTM standards, which define the necessary sample sizes and testing methodologies for such evaluations.
- Data Provenance: The device is manufactured by Comfort Rubber Gloves Industries Sdn Bhd in Matang, Perak, Malaysia. The testing data would originate from laboratory tests conducted on the manufactured gloves.
- Retrospective or Prospective: These tests are prospective (pre-market) evaluations conducted specifically to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical device where "ground truth" is established through standardized laboratory testing protocols (e.g., ASTM D6978 for chemotherapy drug permeation, ASTM D6319 for physical properties, ISO 10993 for biocompatibility) that yield objective measurements, rather than expert interpretation of complex data (like medical images).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not applicable for physical device performance testing.
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
N/A. Not applicable for this physical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. Not applicable for this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements derived from standardized laboratory test methods (e.g., ASTM standards for glove performance and ISO standards for biocompatibility). For instance, the breakthrough detection time for chemotherapy drugs is a direct measurement based on chemical analysis, not expert consensus or clinical outcomes.
8. The sample size for the training set
N/A. This document pertains to a physical medical device (gloves), not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
N/A. This document pertains to a physical medical device (gloves), not an AI/ML system.
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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" arranged around the perimeter. Inside the circle is an abstract image of a stylized human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The figure is depicted in a flowing, dynamic style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2017
Comfort Rubber Gloves Industries Sdn Bhd Chan Men QA & QMS Manager Lot 821, Jalan Matang Matang, Perak 84750 MY
Re: K162405
Trade/Device Name: Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White) Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: February 17, 2017 Received: February 22, 2017
Dear Chan Men:
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 and Part 809); medical device reporting (reporting of
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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 Division 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) K162405
Device Name
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White)
Indications for Use (Describe)
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows:
| Average Breakthrough Detection Time (minutes) | |
|---|---|
| ----------------------------------------------- | -- |
| Cisplatin, 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 |
| Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
| Carmustine (BCNU) 3.3mg/ml | 24.0 (mins) |
| Thiotepa 10.0 mg/ml | 54.9 (mins) |
Please note that the following drugs have extremely low permeation time for:
Carmustine (BCNU) 3.3mg/ml - 24.0 (mins) Thiotepa 10.0 mg/ml - 54.9 (mins)
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."
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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) K162405
Device Name
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue)
Indications for Use (Describe)
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows:
| Average Breakthrough Detection Time (minutes) | |
|---|---|
| ----------------------------------------------- | -- |
| Cisplatin, 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 |
| Paclitaxel (Taxol), 6.0 mg/ml | ≥ 240 |
| Carmustine (BCNU) 3.3mg/ml | 18.2 (mins) |
| Thiotepa 10.0 mg/ml | 57.3 (mins) |
Please note that the following drugs have extremely low permeation time for:
Carmustine (BCNU) 3.3mg/ml - 18.2 (mins) Thiotepa 10.0 mg/ml - 57.3 (mins)
Type of Use (Select one or both, as applicable)
J 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 annound the and review the collection of information. Send comments regarding this burden estimate or any other onpect 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."
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Attachment 17
510(k) SUMMARY
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE AND WHITE)
510(k) SUMMARY
1.0 Submitter :
| Name | Comfort Rubber Gloves Industries Sdn. Bhd. |
|---|---|
| Address | Lot 821, Jalan Matang,34750 Matang, Perak, Malaysia.Malaysia. |
| Phone No. | 605-847 2777 |
| Fax No. | 605-847 9108 |
| Contact Person | Chan Yew Men (Mr.) |
Date of Preparation : March 28, 2017
2.0 Name of the Device
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue)
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White)
| Common Name : | Patient Examination Gloves |
|---|---|
| Classification Name : | Patient Examination Gloves (21 CFR 880.6250 productcode LZA)Patient Examination Gloves Specialty (21 CFR 880.6250productcode LZC) |
| 510(K) Number : | K162405 |
3.0 Identification of The Legally Marketed Devices That equivalency is claimed:
Predicate
- Device Name : Dermagrip Powder Free Blue Nitrile Patient Examination Gloves Tested for Use with Chemotherapy Drugs
- Company : WRP Asia Pacific Sdn Bhd
510(K) No. : K141982
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Attachment 17
4.0 Description of the Device:
The proposed devices are Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim. The qloves are available in two colors: blue and white. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.
5.0 Indication for Use of the Device
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows:
Average Breakthrough Detection Time (minutes)
| Cisplatin, 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 |
| Paclitaxel (Taxol), 6.0 mg/ml | ≥240 |
| Carmustine (BCNU) 3.3 mg/ml | 24.0 (mins) |
| Thiotepa 10.0 mg/ml | 54.9 (mins) |
Please note that the following drugs have extremely low permeation time for:
Carmustine (BCNU) 3.3 mg/ml - 24.0 (mins) Thiotepa 10.0 mg/ml - 54.9 (mins)
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Attachment 17
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows:
Average Breakthrough Detection Time (minutes)
| Cisplatin, 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 |
| Paclitaxel (Taxol), 6.0 mg/ml | ≥240 |
| Carmustine (BCNU) 3.3 mg/ml | 18.2 (mins) |
| Thiotepa 10.0 mg/ml | 57.3 (mins) |
Please note that the following drugs have extremely low permeation time for:
Carmustine (BCNU) 3.3 mg/ml - 18.2 (mins) Thiotepa 10.0 mg/ml - 57.3 (mins)
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White) are summarized with the following technological characteristics compared to ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in Table 1.
Chemotherapy claim is similar to Predicate, which has a gloves thickness comply with the ASTM Standards.
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Attachment 17
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---|---|---|---|
| Predicate 1 | Current | ||
| Manufacturer(s) | WRP Asia Pacific Sdn Bhd | Comfort Rubber GlovesIndustries Sdn. Bhd | |
| 510(k) number | K141982 | - | |
| Length | ASTM D6319 -10(2015) | Length-Min 240mmwidth - min 85 mm for mediumglove | Length-Min 240mmwidth - min 85 mm formedium glove |
| Physical Properties | ASTM D6319 -10(2015) | Meets min 14Mpa before andafter aging.Meets min 500% before agingand min 400% after aging. | Meets min 14Mpa before andafter agingMeets min 500% before agingand min 400% after aging. |
| Thickness – Finger- Palm | ASTM D6319 -10(2015) | Meets min .05 mm for palmand finger thickness. | Meets min .05 mm for palmand finger thickness. |
| Powder Content | ASTM D6124 -06(2011)(≤ 2 mg/glove) | Meets | Meets |
Table 1
Image /page/7/Figure/4 description: The image shows a diagram of a hand with several dimensions labeled. Dimension A is 13 +/- 3 mm, dimension B is 33 +/- 5 mm, and dimension C is 48 +/- 9 mm. Dimension D is labeled as length, and there is a note indicating that dimension C is used to locate the approximate center of the palm with respect to glove size.
Location of thickness and length Measurement
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Attachment 17
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---|---|---|---|
| Predicate | Current | ||
| Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) | |||
| ChemotherapyDrugPermeation Test | ASTM D6978-05 | ||
| Test Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time (min) | |
| Cisplatin | 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide(Cytoxan) | 20 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) | 10.0 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml | >240 | >240 |
| Etoposide (Toposar) | 20.0 mg/ml | >240 | >240 |
| Fluorouracil | 50.0 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 | >240 |
| Ifosfamide | 50.0 mg/ml | >240 | - |
| Mitoxantrone | 2.0 mg/ml | >240 | - |
| Vincristine Sulfate | 1.0 mg/ml | >240 | - |
| *Carmustine (BCNU) | 3.3 mg/ml | 15.0 | 18.2 |
| *Thiotepa | 10.0 mg/ml | 2.0 | 57.3 |
| Warning Statement | * WARNING :Please note that thefollowing drugs haveextremely low permeationtimes Carmustine (BCNU):15 minutes and Thiotepa : 2minutes | * WARNING :Please note that the followingdrugs have extremely lowpermeation times Carmustine(BCNU): 18.2 minutes andThiotepa : 57.3 minutes. |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---|---|---|---|
| Predicate | Current | ||
| Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White) | |||
| ChemotherapyDrug | ASTM D6978-05 | ||
| Permeation Test | |||
| Test Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time (min) | |
| Cisplatin | 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide(Cytoxan) | 20 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) | 10.0 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml | >240 | >240 |
| Etoposide (Toposar) | 20.0 mg/ml | >240 | >240 |
| Fluorouracil | 50.0 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 | >240 |
| Ifosfamide | 50.0 mg/ml | >240 | - |
| Mitoxantrone | 2.0 mg/ml | >240 | - |
| Vincristine Sulfate | 1.0 mg/ml | >240 | - |
| *Carmustine (BCNU) | 3.3 mg/ml | 15.0 | 24.0 |
| *Thiotepa | 10.0 mg/ml | 2.0 | 54.9 |
| Warning Statement | * WARNING :Please note that thefollowing drugs haveextremely low permeationtimes Carmustine(BCNU): 15 minutes andThiotepa : 2 minutes. | * WARNING :Please note that the followingdrugs have extremely lowpermeation times Carmustine(BCNU): 24.0 minutes andThiotepa : 54.9 minutes. | |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
| Predicate | Current | ||
| Biocompatibility | Primary Skin Irritation | Passes | Passes |
| ISO 10993-10:2010Biological evaluationof medical devices --Part 10: Tests forirritation and skinsensitization | Under the conditions ofthe study, the subjectdevice is non-irritating | Under the conditions of thestudy, the subject device isnon-irritating | |
| Dermal Sensitization | Passes | Passes | |
| ISO 10993-10:2010Biological evaluationof medical devices --Part 10: Tests forirritation and skinsensitization | Under the conditions of thestudy, the subject device isnon-sensitization | Under the conditions of thestudy, the subject device isnon-sensitization | |
| Watertight (1000ml) | 21 CFR 800.20ASTM D5151 | Passes | Passes |
| Indication for Use | A patient examinationgloves is a disposabledevice intended formedical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. | The Powder Free NitrileExamination Gloves Tested forUse with Chemotherapy DrugsLabeling Claim (Blue andWhite) is a specialty medicalglove which is a disposabledevice intended for medicalpurpose that is worn on theexaminer's hand or finger toprevent contaminationbetween examiner and patient.In addition these gloves areworn to protect the weareragainst exposure tochemotherapy drugs. | |
| Material | ASTM D6319 -10(2015) | Nitrile | Nitrile |
| Color | - | Blue | Blue or White |
| Size | Medical GloveGuidance Manual -Labeling | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large |
| Single Use | Medical GloveGuidance Manual -Labeling | Single Use | Single Use |
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Attachment 17
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
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Attachment 17
The device and the predicate share the same indication for use, same material, same specifications for thickness and length, similar permeation rate for chemotherapy drugs, similar labeling properties, powder free, biocompatibility and water tight test. Thus, the device substantially equivalent to the predicate.
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
Clinical data is not needed for this device.
9.0 Conclusion
Based on indication for use, technological characteristics and non-clinical performance data, the Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue and White) device - K162405 is substantially equivalent to the predicate device K141982.
§ 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.