(211 days)
Not Found
No
The device is a physical examination glove and the summary describes standard physical and chemical testing, with no mention of AI or ML.
No
The device is described as a medical glove worn to prevent contamination and protect the wearer, which aligns with barrier and protective functions rather than active therapeutic intervention.
No
The device is described as a "specialty medical glove" intended to act as a barrier to prevent contamination and protect the wearer, not to diagnose any condition.
No
The device description clearly states it is a physical product (gloves) and the performance studies focus on physical properties and chemical resistance, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body.
- Device Intended Use: The intended use of these gloves is to be worn on the examiner's hand or finger to prevent contamination and protect against chemotherapy drugs. This is a physical barrier and protective device used on the body (of the examiner).
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, chemical reactions, or diagnostic information derived from samples.
The device is clearly described as a medical glove intended for protection and contamination prevention during medical procedures.
N/A
Intended Use / Indications for Use
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:
Cisplatin, 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
Paclitaxel (Taxol), 6.0 mg/ml: ≥ 240 minutes
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)
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:
Cisplatin, 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
Paclitaxel (Taxol), 6.0 mg/ml: ≥ 240 minutes
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)
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger (worn on the examiner's hand or finger)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical professional/user)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was subjected to non-clinical performance testing. The key results showed that 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. Chemotherapy drug permeation tests were conducted according to ASTM D6978-05 for multiple chemotherapy drugs, showing breakthrough detection times greater than 240 minutes for most tested drugs, and specific lower times for Carmustine (BCNU) and Thiotepa. The gloves also passed biocompatibility tests (Primary Skin Irritation and Dermal Sensitization) based on ISO 10993-10:2010, and passed watertight tests (21 CFR 800.20 ASTM D5151).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average Breakthrough Detection Time for chemotherapy drugs (minutes)
Physical Properties (Mpa before and after aging, % elongation before and after aging)
Thickness – Finger and Palm
Powder Content
Biocompatibility (non-irritating, non-sensitization)
Watertight
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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."
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) 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."
4
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 product |
| code LZA) | |
| Patient Examination Gloves Specialty (21 CFR 880.6250 | |
| product | |
| code 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
5
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)
6
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.
7
Attachment 17
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---|---|---|---|
| Predicate 1 | Current | ||
| Manufacturer(s) | WRP Asia Pacific Sdn Bhd | Comfort Rubber Gloves | |
| Industries Sdn. Bhd | |||
| 510(k) number | K141982 | - | |
| Length | ASTM D6319 - | ||
| 10(2015) | Length-Min 240mm | ||
| width - min 85 mm for medium | |||
| glove | Length-Min 240mm | ||
| width - min 85 mm for | |||
| medium glove | |||
| Physical Properties | ASTM D6319 - | ||
| 10(2015) | Meets min 14Mpa before and | ||
| after aging. | |||
| Meets min 500% before aging | |||
| and min 400% after aging. | Meets min 14Mpa before and | ||
| after aging | |||
| Meets min 500% before aging | |||
| and min 400% after aging. | |||
| Thickness – Finger |
- Palm | ASTM D6319 -
10(2015) | Meets min .05 mm for palm
and finger thickness. | Meets min .05 mm for palm
and 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
8
Attachment 17
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---|---|---|---|
| Predicate | Current | ||
| Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) | |||
| Chemotherapy | |||
| Drug | |||
| Permeation 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 the | |||
| following drugs have | |||
| extremely low permeation | |||
| times Carmustine (BCNU): | |||
| 15 minutes and Thiotepa : 2 | |||
| minutes | * WARNING : | ||
| Please note that the following | |||
| drugs have extremely low | |||
| permeation times Carmustine | |||
| (BCNU): 18.2 minutes and | |||
| Thiotepa : 57.3 minutes. |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
|---|---|---|---|
| Predicate | Current | ||
| Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White) | |||
| Chemotherapy | |||
| Drug | 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 the | |||
| following drugs have | |||
| extremely low permeation | |||
| times Carmustine | |||
| (BCNU): 15 minutes and | |||
| Thiotepa : 2 minutes. | * WARNING : | ||
| Please note that the following | |||
| drugs have extremely low | |||
| permeation times Carmustine | |||
| (BCNU): 24.0 minutes and | |||
| Thiotepa : 54.9 minutes. | |||
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | |
| Predicate | Current | ||
| Biocompatibility | Primary Skin Irritation | Passes | Passes |
| ISO 10993-10:2010 | |||
| Biological evaluation | |||
| of medical devices -- | |||
| Part 10: Tests for | |||
| irritation and skin | |||
| sensitization | Under the conditions of | ||
| the study, the subject | |||
| device is non-irritating | Under the conditions of the | ||
| study, the subject device is | |||
| non-irritating | |||
| Dermal Sensitization | Passes | Passes | |
| ISO 10993-10:2010 | |||
| Biological evaluation | |||
| of medical devices -- | |||
| Part 10: Tests for | |||
| irritation and skin | |||
| sensitization | Under the conditions of the | ||
| study, the subject device is | |||
| non-sensitization | Under the conditions of the | ||
| study, the subject device is | |||
| non-sensitization | |||
| Watertight (1000ml) | 21 CFR 800.20 | ||
| ASTM D5151 | Passes | Passes | |
| Indication for Use | A patient examination | ||
| gloves 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. | The Powder Free Nitrile | ||
| Examination Gloves Tested for | |||
| Use with Chemotherapy Drugs | |||
| Labeling Claim (Blue and | |||
| 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. | |||
| Material | ASTM D6319 - | ||
| 10(2015) | Nitrile | Nitrile | |
| Color | - | Blue | Blue or White |
| Size | Medical Glove | ||
| Guidance Manual - | |||
| Labeling | Extra Small | ||
| Small | |||
| Medium | |||
| Large | |||
| Extra Large | Extra Small | ||
| Small | |||
| Medium | |||
| Large | |||
| Extra Large | |||
| Single Use | Medical Glove | ||
| Guidance Manual - | |||
| Labeling | Single Use | Single Use |
9
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.
10
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.