POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)

K994013 · Glovco (M) Sdn. Bhd. · LYY · Jan 20, 2000 · General Hospital

Device Facts

• Record ID: K994013
• Device Name: POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
• Applicant: Glovco (M) Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Jan 20, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient

Device Story

Device is a powdered latex examination glove. Used by healthcare or similar personnel in clinical settings to provide a barrier against contamination between the user and the patient. The device features a specific labeling claim regarding protein content (100 micrograms or less). It is intended for over-the-counter use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device labeling and general regulatory compliance for examination gloves.

Technological Characteristics

Powdered latex examination glove. Material: Natural rubber latex. Features a protein content labeling claim of 100 micrograms or less.

Indications for Use

Indicated for use by healthcare or similar personnel as a patient examination glove to prevent cross-contamination between the user and the patient.

Regulatory Classification

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 2000

Mr. Tan Chwee Hock Executive Director Glovco (M) SDN BHD Lot 760, Jalan Haji Sirat Off Jalan Meru Klang Selangor D.E., Malaysia

Re : K994013 Powdered Latex Examination Gloves With Trade Name: Protein Content Labeling Claim (100 micrograms or less) Regulatory Class: I Product Code: LYY November 15, 1999 Dated: Received: November 26, 1999

Dear Mr. Hock:

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. A 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

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Page 2 - Mr. Hock

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 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.

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 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

thy 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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## PRE-MARKET NOTIFICATION [510(K)] FOR POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN AND POWDER LABELING CLAIM

: GLOVCO (M) SDN BHD. Applicant Date : NOVEMBER 15, 1999.

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3.0 INDICATION FOR USE

| 510(K) Number (If known) | K994013 |
|--------------------------|-----------------------------------------------------------|
| Device Name | Powdered Latex Examination Gloves with Protein and Powder |
| Claim ( | 100 MICROGRAMS OF LESS) |
| Indications For Use: | |

CONTENT LABELING"A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient".

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use √

(Optional Format 1-2-96)

usion Sign-Off

of Dental, Infection Control, ିଲେମ୍ବର Hospital Devices umber ________________________________________________________________________________________________________________________________________________________________________