(48 days)
Not Found
Not Found
No
The document describes a medical glove and contains no mention of AI or ML technology.
No
The device is an exam glove intended to prevent contamination between patient and examiner, not to treat or alleviate a disease or condition.
No
The device is an exam glove, intended to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device is a physical glove, not software. The description clearly states it is a "disposable device intended for medical purpose that is worn on the examiner's hand".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used during physical examination or procedures.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This glove does not perform any such test.
- Lack of IVD Characteristics: The description and other sections do not mention any testing, analysis of biological samples, or diagnostic purposes.
Therefore, this device falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Textured Powder-Free Latex Exam Glove with Aloe Vera and Protein Content Labeling Claim, Green is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.
Product codes
LYY
Device Description
Not Found
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
medical purpose
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.
AUG 17 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Belle L. Chou General Manager Shen Wei (USA) Incorporated 2845 Whipple Road Union City, California 94587
RE: K992200 Trade Name: Textured Powder-Free Latex Examination Gloves With Aloe Vera Green,contains 50 mcgm or less of total water extractable protein per gram Class: I Product Code: LYY June 29, 1999 Dated: Received: June 30, 1999
Dear Ms. Chou:
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 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). 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 reqistration, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify Failure to comply with the GMP requlation may such assumptions. 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Ms. Chou
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 xitro diaqnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and (301) 594-4692. 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 Other general information on your responsibilities CFR 807.97). 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricio Cucarita Flor
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachment Two
992200
INDICATION FOR USE
Shen Wei (USA) Inc. Applicant:
Device Name: Textured Powder-Free Latex Exam Gloves with Aloe Vera and Protein Content .
Labeling Claim, Green Cortforms . 50 million on less prefern per gram
Indication For Use:
Textured Powder-Free Latex Exam Glove with Aloe Vera and Protein Content Labeling Claim, Green is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
This device is not intended to be used as a chemical barrier.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Qun S. Lin
Concurrence of CDRH Office of Device Evaluation (ODE)
Division Sign-Off Division of Dental, Infection Control, and General Hospital De 510(k) Number
Prescription Use Per 21CFR 801.109 OR
Over-The Counter
(Optional Format 1-2-96)
5