(57 days)
Not Found
No
The document describes a standard patient examination glove and does not mention any AI or ML capabilities.
No.
The device is a patient examination glove, intended to prevent contamination, not to treat a disease or condition.
No
Explanation: The device is a patient examination glove, described as a disposable device intended for medical purposes to prevent contamination. It does not perform any diagnostic function.
No
The device description clearly states it is a patient examination glove, which is a physical, hardware device. There is no mention of 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 to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment. This is a barrier device for infection control.
- Device Description: The description details the physical characteristics and standards met by the glove.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. IVDs are typically reagents, instruments, or systems used for these purposes.
- Anatomical Site: The anatomical site is the "hand," which is where the glove is worn, not where a diagnostic test is performed on a specimen.
Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Product codes
LYZ
Device Description
Class I powder-free patient examination glove LYZ, meets all of the requirements of ASTM Standard D5250-00E1. Class I powdered patient examination glove, LYZ, also meets all the requirements of ASTM Standard D5250-00E1. as well as all the requirements of ASTM Standard D6124-01 for powdered glove and its residue powder.
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
healthcare personnel
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
Non-clinical tests, and by being brought in conformance with the Standard of ASTM D 5252-00E1.
Key Metrics
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
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K053259
- し Submitter:
George Su Crosslinks International 1800 Century Park East, Suite 600 Los Angeles, CA 90067 USA Tel: 310-229-5748 Fax: 310-388-1067 Email: Crosslinks2000@aol.com
Date of Summary: Jan 5, 2006
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- Name of Device Disposable PVC Examination Glove, Powdered and Powder-free
- Predicate Device Information 3.
-
- Device Description:
Class I powder-free patient examination glove LYZ, meets all of the requirements of ASTM Standard D5250-00E1. Class I powdered patient examination glove, LYZ, also meets all the requirements of ASTM Standard D5250-00E1. as well as all the requirements of ASTM Standard D6124-01 for powdered glove and its residue powder.
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- Intended Use
A patient examination glove, either powder-free, is a disposable device intended for medical purposes that is worn on the hand of healthcare and other personnel to prevent contamination between healthcare personnel and the patient's body.
- Intended Use
1
6. Comparison to predicate device:
Practical Protective Plastic Manufactory, Ltd. Disposable PVC Examination Glove, Powdered, and Powder-free, are substantially equivalent in safety and effectiveness to the Pre-powdered Non-sterile Vinyl Examination Glove. from Shandong Perfect Plastic Co., Ltd., and the Powder-free Vinyl Examination Glove of Bernard Technologies, Inc. This conclusion was established based on the Non-clinical tests, and by being brought in conformance with the Standard of ASTM D 5252-00E1.
7. Conclusion:
Practical Protective Plastic Manufactory, Ltd. Disposable PVC Examination Gloves, Powdered, and Powder-free, are substantially equivalent in safety and effectiveness to the legally marketed gloves on the US market: Pre-powdered Non-sterile Vinyl Examination Glove from Shandong Perfect Plastic Co., Ltd., and the Powder-free Vinyl Examination Glove of Bernard Technologies, Inc. It also conforms to ASTM D5250-00E1 standards, as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claim requirements.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized representation of an eagle with three lines forming its wings and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the eagle in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2006
Practical Protective Plastic Manufactory Limited C/O Ms. Laura Danielson Responsible Third Party Official TÜV America, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K053259
Trade/Device Name: (Mutiple Brand Name) Disposable Vinyl Patient Examination Gloves, Powdered and Powder-Free Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: January 3, 2006 Received: January 9, 2006
Dear Ms. Danielson:
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 (Spccial 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 Federal Register.
3
Page-2 Ms. Danielson
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Ques
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 Name: | Practical Protective Plastic manufactory, Ltd. |
|---|---|
| ----------------- | ------------------------------------------------ |
Device Name: (Mutiple Brand Name) Disposable Viny) Patient Examination Gloves, Powdered and Powder-free
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|--------------------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
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Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
anoral Houplia
Shuh H. Munguy to 1/2/06
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