(82 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is a glove intended to prevent contamination, not to treat a medical condition.
No
Explanation: This device is a patient examination glove, described as a disposable barrier to prevent contamination, not for diagnosing conditions.
No
The device is a physical glove, not software. The description clearly states it is a "Powder-free Nitrile Patient Chemotherapy 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 or finger. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description is of a glove, a physical barrier.
- 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 screening of diseases or conditions.
The fact that it's tested for use with chemotherapy drugs relates to its barrier properties and chemical resistance, not its diagnostic capability.
N/A
Intended Use / Indications for Use
A 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. Tested for use with Chemotherapy Drugs.
Product codes
LZC
Device Description
Powder-Free Nitrile Patient Chemotherapy Examination Glove, Blue or Green or Violet or White (Non-colored) Colored
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
Not Found
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/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the bird.
MAR 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Perusahaan Getah Asas. Sdn. Bhd. C/O Mr. Barry S. Sall Principal Consultant PAREXEL consulting 200 West Street Waltham, Massachusetts 02451
Re: K032374/A3
Trade/Device Name: Powder-Free Nitrile Patient Chemotherapy Examination Glove, Blue or Green or Violet or White (Non-colored) Colored Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Codes: LZC Dated: February 18, 2008 Received: February 19, 2008
Dear Mr. Sall:
This letter corrects our substantially equivalent letter of October 22, 2003.
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 (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 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. Sall
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 (OS) 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 continue 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 Office of Compliance at (240) 276-0115 http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Chris S. Imbo, Ph.D.
Chiu S. Lin. Ph.D. 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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Rev. 1 ; Section 3
Page 1 of 1
510 (K) Number (if known) : K032374
Device Name : Powder-free Nitrile Patient Chemotherapy Examination Glove, Blue or Green or Violet or White (Non-colored) Colored
Indications For Use
A 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.
Tested for use with Chemotherapy Drugs.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cat Ary for Chant Ler 10/15/03
n of Anesthesiology. General Hospital. on Control Dental De
510(k) Number: K022374
Prescription Use ( Per 21 CFR 801. 109 ) OR
Over-The-Counter Use
( Optional Format 1-2-96 )