(150 days)
Not Found
Not Found
No
The device description and intended use clearly define a standard examination glove, with no mention of AI/ML or related technologies.
No
The device is a medical glove intended to prevent contamination, not to treat or alleviate a disease or condition.
No
Explanation: The device is an examination glove, which is used to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device description clearly indicates a physical product (a glove) and does not mention any software components.
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 "patient examination glove" worn on the hand or finger to prevent contamination. This is a physical barrier device used during patient examination.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or other chemical processes
- Being used in a laboratory setting for diagnostic purposes
The device described is a Class I medical device (general wellness/low risk) used for infection control during physical examinations.
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."
Product codes
LYY
Device Description
Comfort Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
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
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 features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 23 1998
Mr. Chee Yong Foo Executive Director Comfort Rubber Gloves Industries Sdn. Bhd. Lot 821, Jalan Matang, 34750 Matang, Taiping, Perak Darul Ridzuan, MALAYSIA
K974424 Re : Comfort Powder-Free Latex Examination Gloves Trade Name: with Protein Content Labeling Claim (50 Micrograms or Tess) Regulatory Class: I Product Code: LYY Dated: March 27, 1998 March 31, 1998 Received:
Dear Mr. Chee Yong Foo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate abe beated in one enoise, 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Chee Yong Foo
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdal.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a logo with a black triangle pointing upwards. Inside the triangle is a white hand with the palm facing forward. Below the triangle are the letters "C R G" in a sans-serif font.
LOT 821, JALAN MATANG, 34750 MATANG, TAIPING, PERAK DARUL RIDZUAN, MALAYSIA. TEL : 605-8472777 / 8472888
Attachment 5
INDICATIONS FOR USE STATEMENT
| Applicant | : COMFORT RUBBER GLOVES INDUSTRIES SDN BHD |
|---|---|
| 510(k) No. | : K974424 |
| Device Name | : Comfort Powderfree Latex Examination Glove with Latex ("Powder-free") 80LYY Protein Content Labeling Claim (50 micrograms or less) |
| 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."
Olin Silin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number