(119 days)
Not Found
Not Found
No
The device description and intended use clearly define a physical, disposable glove with no mention of software, algorithms, or data processing, which are necessary components for AI/ML.
No
The device is described as a disposable examination glove used to prevent contamination, which is a barrier function, not a therapeutic intervention to treat or cure a disease or condition.
No
Explanation: The device is a disposable examination glove used for contamination prevention during medical procedures or when handling cytotoxic drugs. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a "disposable examination glove made of synthetic rubber," which is a physical hardware product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the device is a disposable examination glove. Its purpose is to prevent contamination between the patient and examiner or when handling cytotoxic drugs.
- Intended Use: The intended use is for medical purposes, specifically as a barrier on the hands. This is a physical barrier function, not a diagnostic test performed on a sample.
The device's function is to protect the user and the patient through physical separation, which is not the role of an IVD.
N/A
Intended Use / Indications for Use
The device is a disposable examination glove made of synthetic rubber intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner or when handling cytotoxic drugs listed below:
- Carmustine (BiCNU);
- Cyclophosphamide;
- Doxorubicin Hydrochloride;
- 5-Fluorouracil;
- Cisplatin;
- Etoposide;
- Paclitaxel:
- Thio-Tepa
- Dacarbazine
Product codes
LZA, LZC
Device Description
The device is a disposable examination glove made of synthetic rubber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical purposes, patient and examiner
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)
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 or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 9 2008
Ms. Anil Taneja PT MediSafe Technologies JL.Batang Kuis Gg. Tambak Rejo, Desa Buntu Bedimbar, Tanjung Morawa Medan 20362, North Sumatera Indonesia
Re: K082302
Trade/Device Name: Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemo Therapy Drugs Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: November 22, 2008 Received: November 25, 2008
Dear Ms. Taneja:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 -- Ms. Taneja
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); 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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Gupta Y. Mohino md.
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
3.0
INDICATION FOR USE Applicant
: Medisafe Technologies
510(k) Number (if known)
: K082302
Device Name
Indications For Use
Powder Free Blue Nitrile Examination Gloves_Tested for Use with Chemo Therapy Drugs
: The device is a disposable examination glove made of synthetic rubber intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner or when handling cytotoxic drugs listed below:
- Carmustine (BiCNU); ﮩﻨﮯ
- Cyclophosphamide; 2.
- Doxorubicin Hydrochloride; 3.
- 5-Fluorouracil; 4.
- Cisplatin; 5.
- Etoposide; ે.
- Paclitaxel: 1.
- Thio-Tepa 8
- Dacarbazine ರು
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR Office of Device Evaluation (ODE)
Prescription Use Or Over-The-Counter Per 21 CFR 801.109
(optional Format 1-2-96)
- For a new submission, do NOT fill in the 510(k) number blank. contd/-....
Shula W. Murphy, 18
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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