POWDER FREE CHLORINATED GLOVES-(TEXTURED) by PAN-CENTURY RUBBER PRODUCTS SDN. BHD.

This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)." It is a regulatory approval document and does not contain the information requested regarding acceptance criteria or a study proving device performance in the context of an AI/medical device study.

Therefore, I cannot provide the requested information from the given text.

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 features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 1998

Mr. H.R.K. Murthy ·President Pan-Century Rubber Products Sdn. Bhd Lot 230, Jalan Timah 2, Pasir Gudang Industrial Estate, 81700 Pasir Gudang, Johor, MALAYSIA

Re : K981164 Powder-Free Latex Examination Gloves with Trade Name: Protein Labeling Claim (50 Micrograms or Less) Regulatory Class: I .. ... ... ... ... ... ... Product Code: LYY Dated: March 26, 1998 March 31, 1998 Received:

Dear Mr. H.R.K. Murthy:

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, 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. पु 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 requlation 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

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Page 2 - Mr. H.R.K. Murthy

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 described in your six promatence of your device to a legally rinding of bubbuller cquresults in a classification for your markets produced 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 (301) 594-4692. 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 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 (800) 638-2041, or (301) 443-6597 or at its internet address "http://www.fda.gpv/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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਼ ਸ਼ Page

ANNEXURE XVI

er-The-Counter-Souncer-2-96)
(Optional Format 1-2-96)

K981164 SIO(K) MUMBER (IF KNOWN) : _ POWDER FREE ( TEXTURED ) LATEX EXAMINATION GLOVES ATTH PROTETH LABELLING CLAINS ( 50 MICROGRAMS OR LESS )
CONTRACTED ( TEXTURED ) LATEX EXAMINATION CELAINS OR LESS ) DEVICE NAME: INDICATIONS FOR USE:

A DISPOSAL DEVICE TO PREVENT CONTAMINATION BETWEEN THE PATIENT AND EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN THE PATIENT AND 2) EXAMINER .

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

ﻬﺎ: ﻫ

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter-Use

Prescription Use Prescription 201.109)

ાં તેમ જ દૂધની ડેરી જેવી સવલતો પ્રવામાં આવેલું છે. આ ગામનાં મુખ્યત્વે ખેત

Chin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K981164

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.