(263 days)
No
The summary describes a simple disposable medical glove and contains no mention of AI or ML technology.
No.
The device is a medical glove intended as a barrier for protection, not for treating or rehabilitating a medical condition.
No
Explanation: The device is described as a medical glove, which provides a barrier against contaminants and infectious materials. Its primary function is protection, not diagnosis.
No
The device description clearly states it is a disposable device made of natural rubber latex material, indicating it is a physical hardware product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the hand as a barrier against infectious materials and contaminants. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description focuses on the material and form of the device (disposable latex glove).
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances
- Providing information for diagnosis, monitoring, or screening
The device described is a medical glove, which is a Class I or Class II medical device depending on its intended use and claims, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
It is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Product codes
LYY
Device Description
Powder-Free Latex Examination Gloves WITH PROTEIN CONTO 300 MICROGRAMS OR LESS LABELING CLAIM
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
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)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tony T.K. Cheng Shanghai Motex Healthcare Company Limited No. 6318 Fang Huang Road Huaxin, Qingpu, 20178 Shanghai, CHINA
Re: K020837
Trade/Device Name: MOTEX Powder-Free Examination Gloves with Protein Labeling Claim (300 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: October 1, 2002 Received: October 8, 2002
Dear Mr. Cheng:
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 vour device in the Federal Register.
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Page 2 - Mr. Cheng
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 Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susak Kunner
Timothy A. Ulatowski 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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INDICATIONS FOR USE STATEMENT ಗ
SHANGHAI MOTEX HEALTHCARE CO., LTD Applicant : _ K020837 510(k) Number : _ (New Applicant) motex Device Name : Powder-Free Latex Examination Gloves WITH PROTEIN CONTO 300 MICROGRAMS OR LESS LABELING CLAIM Indications for Use :
It is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter
(Optional Format 1-2-96)
Surat Kumar
inn Sinn ion of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K000833
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