LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)

• K Number: K973871
• Device Name: LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)
• Manufacturer: HARTALEGA SDN BHD
• Date Cleared: 1997-12-11 ( 62 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Powdered Latex Examination Gloves with Protein Content Labeling Claim of 100 micrograms or less.

AI/ML Overview

The provided text is a 510(k) approval letter from the FDA for "Latex Powdered Examination Gloves w/Protein Content Labeling Claim of 100 Micrograms or less". However, it does not contain specific details about acceptance criteria, device performance tables, sample sizes, expert qualifications, or study methodologies that are typically found in a clinical study report or a more detailed submission document.

This document is a regulatory approval, stating that the device is substantially equivalent to a predicate device and can be marketed. It refers to the "indications for use" and general regulatory compliance.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts used or their qualifications for ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
6. Information about a standalone (algorithm only) performance study.
7. The type of ground truth used (expert consensus, pathology, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Summary

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I I 1997

Mr. Konq Wai Kuan Q.A. Manager Hartalega sdn. bhd. 9 Jalan Kuanq Bulan Taman Kepong Industrial Estate 52100 Kuala Lumpur, MALAYSIA

Re : K973871 Trade Name: Latex Powdered Examination Gloves w/Protein Content Labeling Claim of 100 Micrograms or Tess Requlatory Class: I Product Code: LYY October 6, 1997 Dated: Received: October 10, 1997

Dear Mr. Kong Wai Kuan:

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 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Konq Wai Kuan

This letter will allow you to beqin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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510(k) Number (if known) : K973871

Device Name : Powdered Latex Examination Gloves with Protein Content Labeling Claim of 100 micrograms or less.

Indications For Use :

The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chun S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .

Prescription Use (Per 21 CFR 801.109) OR

X Over-The-Counter Use (Optional Format 1-2-96)

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.