K Number
K961634
Device Name
NIL - POWDER-FREE LATEX EXAMINATION GLOVES
Date Cleared
1997-06-16

(413 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 purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder-Free Latex Examination Gloves
More Information

Not Found

Not Found

No
The 510(k) summary describes a standard examination glove and contains no mention of AI, ML, or related technologies.

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

No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. Its purpose is protective, not diagnostic. It does not gather any information about the patient's health status to aid in diagnosis.

No

The device description clearly states it is a physical glove, not software.

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 examiner's hand or finger to prevent contamination between patient and examiner." This describes a physical barrier device used for protection, not a device used to examine specimens in vitro (outside of the body) to diagnose or monitor a medical condition.
  • Device Description: "Powder-Free Latex Examination Gloves" further reinforces the nature of the device as a physical barrier.
  • Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.

Therefore, this device falls under the category of a medical device, but not specifically 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 examiner's hand or finger to prevent contamination between patient and examiner.

Product codes

LYY

Device Description

Powder-Free Latex Examination Gloves

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

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Anatomical Site

hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them that could represent hair or clothing. The overall design is simple and conveys a sense of unity and service.

JUN 1 6 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Yunus Latif Felda Rubber Industries SDN BHD Head Office 7th Floor, Balai Felda Jalan Gurney 1 Kuala Lumpur, Malaysia 体

K961634 Re : Powder-Free Latex Examination Gloves Trade Name: Requlatory Class: I Product Code: LYY Dated: April 10, 1997 Received: April 15, 1997

Dear Mr. Latif:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 affectinq your device can be found in the Code of Federal Requlations, 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 such assumptions. Failure to comply with the GMP requlation may result in requlatory 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

1

Page 2 - Mr. Latif

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 mequlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Alitorist

Timothy A. Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices

market the aevice, supject to finelai controlle provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 affectinq your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ 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 such assumptions. Failure to comply with the GMP requlation may result in requlatory 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

2

INDICATIONS FOR USE

Applicant : Felda Rubber Industries Sdn Bhd

510(k) Number (if known) : K96 | 6 34

Device Name : _ Powder Free Latex Examination Gloves

Indications For use :

A 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.

(PLEASE DO NOT WRITE BELEOW THIS LINE - CONTINUE ON ANOTHER FACE - IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Clint Sitton
Division Sign-Off

(Division Sign Division of Dental, Inst and Ganeral Hosp 510(k) Number

Prescription Use Per 21 CFR 801.109

OR

Over-The-Counter


(Optional Format 1-2-96)