(93 days)
Not Found
Not an AI, DNN, or ML device.
No
The 510(k) summary describes examination gloves and their performance against chemotherapy drugs, with no mention of AI or ML technology.
No
The device is described as a glove intended to prevent contamination for both the wearer and the patient, and to provide protection against chemotherapy drugs. It does not treat or cure any medical condition.
No
The device is a non-sterile disposable glove intended to prevent contamination for the examiner, not to diagnose a condition.
No
The device is a physical glove, not software. The description clearly states it is a "Nitrile Powder Free Examination Gloves".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a glove worn on the examiner's hand to prevent contamination. It's a barrier device, not a diagnostic test.
- Intended Use: The intended use is for medical and dental purposes to prevent contamination, not to diagnose or test for anything.
- Performance Studies: The performance studies focus on the glove's resistance to chemotherapy drugs (breakthrough time), which is a measure of its barrier function, not its diagnostic capability.
Therefore, based on the provided information, this device is a medical glove, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs is a non-sterile disposable device intended for medical and dental purpose that is wor on the examiners hand to prevent contraniation total weather and examiner. It is also tested to be assess of the list of Chemotherapy Drugs tested (with breakthrough times) as per attached table. Please note that Carmustine and Thiotepa have externely low permeation times of 45.4 minutes and 30.9 minutes, respectively.
Product codes
LZA, LZC
Device Description
Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical and dental 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
Permeation Test Results of Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs.
Chemotherapy Drugs (Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), Cisplatin 1.0 mg/ml (1,000 ppm), Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm), Dacarbazine (DTIC) 10.0 mg/ml ( 10,000 ppm), Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm), Etoposide (Toposar) 20.0 mg/ml (20,000 ppm), Fluorouracil 50.0 mg/ml (50,000 ppm), Ifosfamide 50.0 mg/ml (50,000 ppm), Methotrexate 25.0 mg/ml (25,000 ppm), Mitomycin C 0.5 mg/ml (500 ppm), Mitoxantrone 2.0 mg/ml (2,000 ppm), Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm), Thiotepa 10.0 mg/ml (10,000 ppm), Vincristine Sulfate 1.0 mg/ml (1,000 ppm))
Summary of Performance Studies
Not Found
Key Metrics
Minimum Breakthrough Time (Minutes) for Carmustine (BCNU) 3.3 mg/ml (3,300 ppm): 45.4
Minimum Breakthrough Time (Minutes) for Cisplatin 1.0 mg/ml (1,000 ppm): > 240
Minimum Breakthrough Time (Minutes) for Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm): > 240
Minimum Breakthrough Time (Minutes) for Dacarbazine (DTIC) 10.0 mg/ml ( 10,000 ppm): > 240
Minimum Breakthrough Time (Minutes) for Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm): > 240
Minimum Breakthrough Time (Minutes) for Etoposide (Toposar) 20.0 mg/ml (20,000 ppm): > 240
Minimum Breakthrough Time (Minutes) for Fluorouracil 50.0 mg/ml (50,000 ppm): > 240
Minimum Breakthrough Time (Minutes) for Ifosfamide 50.0 mg/ml (50,000 ppm): > 240
Minimum Breakthrough Time (Minutes) for Methotrexate 25.0 mg/ml (25,000 ppm): > 240
Minimum Breakthrough Time (Minutes) for Mitomycin C 0.5 mg/ml (500 ppm): > 240
Minimum Breakthrough Time (Minutes) for Mitoxantrone 2.0 mg/ml (2,000 ppm): > 240
Minimum Breakthrough Time (Minutes) for Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm): > 240
Minimum Breakthrough Time (Minutes) for Thiotepa 10.0 mg/ml (10,000 ppm): 30.9
Minimum Breakthrough Time (Minutes) for Vincristine Sulfate 1.0 mg/ml (1,000 ppm): > 240
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2015
Hartalega Sdn. Bhd. Ms. Nurul Aisyah Kong Binti Abdullah Quality Assurance Senior Manager No. 7 Kawasan Perusahaan Suria Bestari Jaya Selangor Darul Ehsan 45600 MALAYSIA
Re: K150103
Trade/Device Name: Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: March 18, 2015 Received: March 23, 2015
Dear Ms. Abdullah:
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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
510(k) Number (if known) K150103
Device Name
Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs is a non-sterile disposable device intended for medical and dental purpose that is wor on the examiners hand to prevent contraniation total weather and examiner. It is also tested to be assess of the list of Chemotherapy Drugs tested (with breakthrough times) as per attached table. Please note that Carmustine and Thiotepa have externely low permeation times of 45.4 minutes and 30.9 minutes, respectively.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Permeation Test Results of Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs.
| Chemotherapy Drugs | Minimum Breakthrough Time
(Minutes) |
|-----------------------------------------------------|----------------------------------------|
| Carmustine (BCNU)
3.3 mg/ml (3,300 ppm) | 45.4 |
| Cisplatin
1.0 mg/ml (1,000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan)
20 mg/ml (20,000 ppm) | > 240 |
| Dacarbazine (DTIC)
10.0 mg/ml ( 10,000 ppm) | > 240 |
| Doxorubicin Hydrochloride
2.0 mg/ml (2,000 ppm) | > 240 |
| Etoposide (Toposar)
20.0 mg/ml (20,000 ppm) | > 240 |
| Fluorouracil
50.0 mg/ml (50,000 ppm) | > 240 |
| Ifosfamide
50.0 mg/ml (50,000 ppm) | > 240 |
| Methotrexate
25.0 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C
0.5 mg/ml (500 ppm) | > 240 |
| Mitoxantrone
2.0 mg/ml (2,000 ppm) | > 240 |
| Paclitaxel (Taxol)
6.0 mg/ml (6,000 ppm) | > 240 |
| Thiotepa
10.0 mg/ml (10,000 ppm) | 30.9 |
| Vincristine Sulfate
1.0 mg/ml (1,000 ppm) | > 240 |
្រ
r
.
ﻣ
a
o
ः