(60 days)
Not Found
Not Found
No
The device description and intended use clearly define a standard medical examination glove, with no mention of AI or ML capabilities.
No.
The device description states it is an "Examination Glove" intended to "prevent contamination between patient and examiner." This indicates it is a barrier device for protection, not one designed to treat or alleviate a disease or condition.
No
Explanation: The device is described as a glove worn on the examiner's hand to prevent contamination, which is a protective barrier function, not a diagnostic one. It does not mention any capability to assess, measure, or determine a health condition or disease.
No
The device is a physical glove, not software. The description clearly states it is a "Powder Free Nitrile Examination Glove".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical glove with specific material properties and testing for chemotherapy drug use. It doesn't describe any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
This device falls under the category of a medical device, specifically a barrier device used for infection control.
N/A
Intended Use / Indications for Use
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs.
Product codes
LZC, LZA
Device Description
Powder Free Nitrile Examination Glove (Blue). This Product Device Name: Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2008
Mr. Foo Khon Pu Smart Glove Corporation Sdn. Bhd. Lot 6487 Batu 5 34, Sementa Jalan Kapar, 42100 Klang Selangor Darul Ehsan MALAYSIA
Re: K082370
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC, LZA Dated: October 8, 2008 Received: October 10, 2008
Dear Mr. Pu:
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.
1
Page 2 - Mr. Pu
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 (Sections 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 yours,
Clu G
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): ҚО 82370
Powder Free Nitrile Examination Glove (Blue). This Product Device Name: Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Tested For Use With Chemotherapy Drugs.
Indication For Use:
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
X Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Shade A. Murphy, RD
(Division Sign-Off)
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Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: 082370
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