K Number
K042952
Device Name
VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE
Date Cleared
2005-03-10

(135 days)

Product Code
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purpose that A patient cxaminer's hands or finger to prevent contamination between patient and examiner.
Device Description
Powder-Free Vinyl Examination Gloves
More Information

Not Found

Not Found

No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related concepts.

No
The device, a patient examination glove, is intended to prevent contamination, not to treat a medical condition or disease.

No
The device, a patient examination glove, is described as preventing contamination between patient and examiner, which is a preventive measure rather than a diagnostic one. It does not identify or measure a condition or disease.

No

The device description clearly states it is a "Powder-Free Vinyl Examination Glove," which is a physical hardware device, 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 prevent contamination between a patient and an examiner's hands or fingers. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
  • Device Description: It's described as a "Powder-Free Vinyl Examination Glove," which is a physical barrier device.
  • 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.)
    • Detecting or measuring substances in samples
    • Providing information for diagnosis, monitoring, or screening

IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This glove does not perform such a function.

N/A

Intended Use / Indications for Use

A patient examination glove is a disposable device intended for medical purpose that a patient cxaminer's hands or finger to prevent contamination between patient and examiner.

Product codes

LYZ

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

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

Not Found

Key Metrics

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services in the USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

MAR 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zibo Hengchang Plastic & Rubber Products Company Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K042952

Trade/Device Name: Powder-Free Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: February 26, 2005 Received: February 28, 2005

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowled your and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in moreditorions for also baber to May 28, 1976, the enactment date of the Medical Device Incrisiate commerce prior to thay a been reclassified in accordance with the provisions of Antendinents, of to do rought Act (Act) that do not require approval of a premarket the Federal Food, Drag, and Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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 (1 Wri), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device ear oc roundsh further announcements concerning your device in the Lederal Register.

1

Page 2 - Mr. Job

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualles of a substantes with other requirements mean that FDA has made a decemination that your and your receral agencies.
of the Act or any Federal statutes and regulations administered by penistration of the Act or any rederal statues and regirements, including, but not limited to: registration
You must comply with all the Act 's requirements and manufacturing progrice You must comply with an the Act 3 requirements and 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 800'; and i and listing (21 CFR Fall 807), labeling (21 OFF Craires) /
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (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) This letter will anow you to begin mailer.ing your device of your device to a premarket notification. The FDA miding or substains of as a casification 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), If you desire specific auvice for your de at (240) 276-0115. Also, please note the regulation please contact inc Office or Comphanes are (210) = = = = = = = = = = = = = may obtain other general information on your responsibilities under the Act from the may obtain other general miorinational and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ours

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

2

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

A patient examination glove is a disposable device intended for medical purpose that A patient cxaminer's hands or finger to prevent contamination between patient and examiner.

Prescription Use __ (Part 21 CFR 801 Subpart 1)

AND/OR

Over-The-Counter Use X
(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)

Schute M. Chie MD

Division Sian-Off Ivision of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number K042752

EXHIBIT B