(266 days)
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Not Found
No
The 510(k) summary describes a standard examination glove and its performance against chemotherapy drugs. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
No
The device, a disposable examination glove, is intended to prevent contamination between the examiner and patient, not to treat or alleviate a medical condition. While it has been tested for chemotherapy drug permeation, this is a protective function, not a therapeutic one.
No
The device description indicates it is an examination glove, used to prevent contamination between examiner and patient, and is tested for use with chemotherapy drugs. Its purpose is protective, not to diagnose a medical condition.
No
The device is a physical glove, not a software application. The description clearly states it is a "disposable device intended for medical purposes that is worn on the examiner's hand or fingers".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health.
- This device is a glove worn on the hand. Its purpose is to prevent contamination between the examiner and the patient. It does not analyze any biological samples.
The information provided clearly describes a medical device used for barrier protection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Powder-Free Blue Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between Examiner and Patient. Tested for use with Chemotherapy Drugs as listed below.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
The following chemicals have been tested with these gloves
1 Carmustine 1.04
2 Cisplatin >240
3 Cyclophosphamide >240
4 Dacarbazine >240
5 Doxorubicin Hydrochloride >240
6 Etoposide >240
7 Flourouracil >240
8 Paclitaxel >240
9 Thiotepa = 165
Please note that Carmustine has an extremely low permeation time of less than 30 minutes.
Product codes
LZA, LZC
Device Description
Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
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
Examiner's hand or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Medical purposes
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)
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
The following chemicals have been tested with these gloves:
1 Carmustine 1.04
2 Cisplatin >240
3 Cyclophosphamide >240
4 Dacarbazine >240
5 Doxorubicin Hydrochloride >240
6 Etoposide >240
7 Flourouracil >240
8 Paclitaxel >240
9 Thiotepa = 165
Please note that Carmustine has an extremely low permeation time of less than 30 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Carmustine breakthrough detection time: 1.04 minutes
Cisplatin breakthrough detection time: >240 minutes
Cyclophosphamide breakthrough detection time: >240 minutes
Dacarbazine breakthrough detection time: >240 minutes
Doxorubicin Hydrochloride breakthrough detection time: >240 minutes
Etoposide breakthrough detection time: >240 minutes
Flourouracil breakthrough detection time: >240 minutes
Paclitaxel breakthrough detection time: >240 minutes
Thiotepa breakthrough detection time: = 165 minutes
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of thick, curved lines. The eagle's head is facing to the left, and its tail feathers are depicted with a wavy, flowing design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Anil Taneja Chief Executive Officer PT. Medisafe Technologies JL. Batang Kuis GG. Tambak Rejo Desa Buntu Bedimbar TJ. Morawa Medan, North Sumatera Indonesia 20362
JUN - 6 2011
Re: K102623
Trade/Device Name: Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA, LZC Dated: May 16, 2011 Received: May 23, 2011
Dear Mr. Taneje:
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.
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Page 2- Mr. 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); 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/ucm 115809.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/Safetv/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,
Cintmony D. Water
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
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ATTACHMENT B
Indications for Use
Applicant : Medisafe Technologies
510(k) Number (if known): Not Known
Device Name: Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs.
Indications For Use:
Powder-Free Blue Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between Examiner and Patient. Tested for use with Chemotherapy Drugs as listed below.
| Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
| The following chemicals have been tested with these gloves | ||
|---|---|---|
| 1 | Carmustine | 1.04 |
| 2 | Cisplatin | >240 |
| 3 | Cyclophosphamide | >240 |
| 4 | Dacarbazine | >240 |
| 5 | Doxorubicin Hydrochloride | >240 |
| 6 | Etoposide | >240 |
| 7 | Flourouracil | >240 |
| 8 | Paclitaxel | >240 |
| 9 | Thiotepa | = 165 |
Please note that Carmustine has an extremely low permeation time of less than 30 minutes.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR .
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth T. Clarence-Williams
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102623