(195 days)
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Not Found
No
The device description and intended use clearly define a simple, disposable medical glove with no mention of any computational or analytical capabilities, let alone AI/ML.
No
The device, an examination glove, is intended for preventing contamination, not for treating a disease or condition.
No
Explanation: The device is a patient examination glove, which is used to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device description clearly states it is a "DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR," which is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is a "PATIENT EXAMINATION GLOVE" intended to be "WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER."
- Lack of IVD Characteristics: The description does not mention any testing of biological specimens, analysis of bodily fluids, or any diagnostic purpose related to a patient's health status based on in vitro testing.
The device described is a barrier device used for infection control during patient examinations.
N/A
Intended Use / Indications for Use
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Product codes
LYZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
HAND OR FINGERS
Indicated Patient Age Range
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Intended User / Care Setting
EXAMINER'S
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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
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§ 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 Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 17 2004
Mr. Danny Wang Manager Shanghai Palomar Mountain Industries, Incorporated No. 1, Biyu Road, Cangqiao Township, Songjiang County, Shanghai, CHINA, P.R.C
Re: K031142
Trade/Device Name: Disposable Powdered Vinyl Synthetic Examination Gloves. White Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: December 10, 2002 Received: January 26, 2004
Dear Mr. Wang:
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 liederal Register.
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Page 2 - Mr. Wang
Please be adviscd 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. 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 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.
SHui
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
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INDICATIONS FOR USE
Applicant: SHANGHAI PALOMAR MOUNTAIN
INDUSTRIES, INC.
K 031112 510(k) Number (if known): ___
Device Name: DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
Indications For Use:
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use Y (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Martha T. O'Lone
Interim Branch Chief INCB
Page 1 of __
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices,
| 510(k) Number: | K031142 K031142 |
|---|---|
| ---------------- | ----------------- |