(110 days)
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Not Found
No
The 510(k) summary describes a patient examination glove and its performance against chemotherapy drugs. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No.
The device is a patient examination glove, intended to prevent contamination, not to treat a medical condition.
No
The device is described as a "powder free patient examination glove," used to prevent contamination, not to diagnose medical conditions, and its stated purpose is protective.
No
The device is a physical product (a glove) and the summary describes its physical properties and performance against chemical permeation, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "powder free patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination or procedures.
- IVD Definition: In vitro diagnostics are medical devices intended to perform tests on specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
- Device Description and Function: The description focuses on the glove's function as a barrier and its resistance to chemotherapy drugs. It does not mention any testing of patient specimens or analysis of biological samples.
- Performance Studies: The performance studies described relate to the glove's barrier properties against chemotherapy drugs, not to the analysis of patient samples for diagnostic purposes.
The testing for chemotherapy drug permeation is a safety and performance characteristic of the glove as a barrier device, not an indication that it is used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A powder free 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection
Time (Minutes) |
|---|---|
| Cisplatin, 1.0mg/ml (1,000ppm) | >240 |
| Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240 |
| Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 0.53 |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 |
| Fluorouracil, 50.0mg/ml (50,000ppm) | >240 |
| Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240 |
| Thiotepa, 10.0mg/ml (10,000ppm) | 75.54 |
Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml (3,300ppm) Thiotepa, 10.0mg/ml (10,000ppm)
Product codes
LZA, LZC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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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 stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Yap P. Geeh Assistant Technical Sales Manager MAXTER GLOVE MANUFACTURING SDN BHD Lot 6070. Jalan Haji Abdul Manan 610 Miles Off Jalan Meru Klang, Selangor MALAYSIA 41050
FEB - 6 2012
Re: K113100
Trade/Device Name: Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: January 16, 2012 Received: January 19, 2012
Dear Mr. Geeh:
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 Eederal Register.
1
Page 2 - Mr. Geeh
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
$\$$ fa Anthony D. lvatson
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows a logo for MAXTER GLOVE MANUFACTURING SDN. BHD. The logo features a black silhouette of a cat-like animal on the left side. To the right of the animal is the text "MAXTER" in bold, capitalized letters. Below the company name is the text "GLOVE MANUFACTURING SDN. BHD. (229652-H)".
LOT 6070
Jalan Haji Abdu! Manan, 6th Miles Off Jalan Meru, 41050 Klang, Selangor, Malaysia. Tel: 603-33929888 (8 Lines) Fax: 603-33923328 E-MAIL: maxter@tm_net.my
INDICATIONS FOR USE
Applicant:
Maxter Glove Manufacturing Sdn. Bhd.
510(K) Number (if known):
Device Name:
Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (Non-Sterile)
Indications For Use:
A powder free 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection
Time (Minutes) |
|-------------------------------------------------|--------------------------------------------------|
| Cisplatin, 1.0mg/ml (1,000ppm) | >240 |
| Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240 |
| Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 0.53 |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 |
| Fluorouracil, 50.0mg/ml (50,000ppm) | >240 |
| Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240 |
| Thiotepa, 10.0mg/ml (10,000ppm) | 75.54 |
Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml (3,300ppm) Thiotepa, 10.0mg/ml (10,000ppm)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Elijah D. Williams
neurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113100