(344 days)
Not Found
Not Found
No
The device is a patient examination glove, and the description focuses on its material properties and resistance to chemicals, not on any computational or analytical capabilities.
No
This device is a protective barrier (glove) intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device is a patient examination glove used for protection, not for diagnosing any medical condition.
No
The device described is a physical medical device (patient examination gloves) and does not involve any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Intended Use of the Device: The intended use of this device is clearly stated as 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 is a barrier device used on the body (or the examiner's hand) for protection.
- Function of the Device: The device's function is to provide a physical barrier. While it has been tested for resistance to certain chemicals (chemotherapy drugs and Fentanyl Citrate), this testing relates to its barrier properties and safety for the user, not to diagnosing a condition in a patient.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health.
The testing for chemotherapy drug and Fentanyl Citrate resistance is a performance characteristic of the glove as a protective barrier, not a diagnostic function.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
Non-Sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs.
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
|---|---|
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine, 3.3 mg/ml | 11.0 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 | 59.0 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): 11.0 minutes ThioTEPA (10.0 mg/ml): 59.0 minutes
WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate.
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
|---|---|
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine, 3.3 mg/ml | 15.0 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 | 30.1 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
| Fentanyl Citrate, 100mcg/2ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 15.0 minutes ThioTEPA (10.0 mg/ml): 30.1 minutes
WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA
Product codes
LZA, LZC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purpose)
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 gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The results indicate average breakthrough detection times for various chemotherapy drugs, with some having extremely low permeation times (Carmustine, ThioTEPA), leading to a warning not to use the gloves with these specific drugs. The gloves were also tested for Fentanyl Citrate permeation with a breakthrough detection time of > 240 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average Breakthrough Detection Time (minutes)
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 11, 2021
YTY Industry (Manjung) SDN BHD Punitha Samy Senior Manager (YTY Group DCRA & YTY Industry QA) Lot 1422-1424, Batu 10 Lekir Sitiawan, Perak 32020 Malaysia
Re: K202536
Trade/Device Name: Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs and Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: July 8, 2021
Received: July 12, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bifeng Qian -S
For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Non-Sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs.
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
| Aloe Vera | |
|---|---|
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine, 3.3 mg/ml | 11.0 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 | 59.0 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): 11.0 minutes ThioTEPA (10.0 mg/ml): 59.0 minutes
WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA
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.
3
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
Indications for Use
510(k) Number (if known)
Device Name
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate.
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
|---|---|
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine, 3.3 mg/ml | 15.0 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 | 30.1 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
| Fentanyl Citrate, 100mcg/2ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 15.0 minutes ThioTEPA (10.0 mg/ml): 30.1 minutes
WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA
| 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.
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 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."