POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM

• K Number: K011563
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM
• Manufacturer: U.O.P. RUBBER PRODUCTS SDN BHD
• Date Cleared: 2001-06-05 ( 15 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and the patient.

Device Description

POWDER FREE LATEX EXAMINATION GLOVES. WITH WATER EXTRACTABLE PROTEIN LABELLING CLAI

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA to U.O.P. Rubber Products Sdn Bhd regarding their "Powder Free Latex Examination Gloves with Water Extractable Protein Labeling Claim." This document confirms the substantial equivalence of the device to legally marketed predicate devices.

However, the document does not contain information about:

1. Specific acceptance criteria or reported device performance metrics in a table.
2. Details of any study (e.g., sample sizes, data provenance, expert qualifications, adjudication methods) that would establish the device meets performance criteria for AI/ML.
3. Multi-reader multi-case (MRMC) comparative effectiveness studies.
4. Standalone algorithm performance studies.
5. Type of ground truth used in such studies.
6. Training set sample size or how its ground truth was established.

This type of FDA letter focuses on the regulatory clearance process for a relatively standard medical device (examination gloves) based on substantial equivalence, rather than a detailed performance study for an AI/ML-driven device. The "Indication For Use" attachment clarifies the intended use of the gloves but does not delve into performance metrics or study designs for AI.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as this information is not present in the document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, suggesting a sense of protection and care.

JUN - 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chua Beng Chuan Managing Director U.O.P. Rubber Products Sdn Bhd 878 Jalan Bandar Baru Nibong Tebal Penang. MALAYSIA

Re : K011563 Powder Free Latex Examination Gloves Trade/Device Name: with Water Extractable Protein Labeling Claim ( 50 Micrograms or Less ) Requlation Number: 880.6250 I Regulatory Class: Product Code: LYY Dated: May 5, 2001 May 21, 2001 Received:

Dear Mr. Chuan:

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 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). 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 (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that,

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Page 2 - Mr. Chuan

through periodic QS inspections, the Food and Drug Chrough periodic go inspectify such assumptions. Failure to Adminisclacion (IMP regulation may result in regulatory In addition, FDA may publish further announcements action. action: In aur device in the Federal Register. Please note: concerning your acvros in area in a submission submission does chirs response to your promobility have under sections 531 not arress and the Act for devices under the Electronic chrough 342 or eno notrol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as Inis receir will arrew your your market notification. The FDA described in your srown provilence of your device to a legally Finding of subbeaneral oquination in a classification for your marketed predicate awves 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 regaradian (stic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compreason as (advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be Information on Journali Manufacturers Assistancers Assistance obtained from che biving [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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U.O.P. Rubber Products Sdn.Bhd.

878 Jalan Bandar Baru, 14300 Nibong Tebal, Pulau Pinang, Malaysia. Fax : [phone] Tel : [phone] Our Ref : CBC/050501/04 Date : 05/05/2001 Your Ref :

ATTACHMENT 2 :

INDICATION FOR USE

Applicant : U.O.P. RUBBER PRODUCTS SDN. BHD.

01 1563 510(k) Number (if known) : _

Device Name : POWDER FREE LATEX EXAMINATION GLOVES. WITH WATER EXTRACTABLE PROTEIN LABELLING CLAI

Page : 1/1

Trade Name : (1) SANI-SAFE (2) Other clients private labeling

Indication For Use :

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and the patient.

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use		OR	Over-The-Counter	X
Per 21 CFR 801.109

Qin S. Lim
(Division Sign-Off)

Division of Dental, Infection Control,
and General Hospital Devices

510(k) Number	K011563
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Regulation Number and Section

§ 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.