GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

K993752 · Glovco (M) Sdn. Bhd. · LYY · Dec 3, 1999 · General Hospital

Device Facts

• Record ID: K993752
• Device Name: GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
• Applicant: Glovco (M) Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Dec 3, 1999
• 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

Powder-free chlorinated latex examination gloves; designed to provide a barrier against contamination between healthcare personnel and patients. Used in clinical or similar settings by healthcare workers. Device features a protein labeling claim of 50 micrograms or less. Provides physical barrier protection; reduces risk of cross-contamination during patient examinations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Chlorinated latex. Form factor: Examination glove. Feature: Powder-free with protein labeling claim (50 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 1999

Mr. Tan Penq Hock Managing Director Glovco (M) Sdn. Bhd. Lot 760, Jalan Haji Sirat Off Jalan Meru Klang, Selangor D.E., Malaysia

K993752 Re: Powder-free Chlorinated Latex Examination Trade Name: Gloves With Protein Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: LYY October 25, 1999 Dated: November 5, 1999 Received:

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, Druq, 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 Regulations, 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

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Page 2 - Mr. Hock

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 yitro diaqnostic 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 gener 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, Univer

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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## PREMARKET NOTIFICATION [510(K)] FOR POWDER-FREE CHLORINATED LÀTËX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM

Applicant : GLOVCO (M) SDN BHD. : OCTOBER 25, 1999. Date

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## 3.0 INDICATION FOR USE

: _ Kag 3752 510(K) Number (If known) : Powder-free Chlorinated Latex Examination Gloves with Proteing Device Name r gra Labeling Claim Indications For Use:

"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 X

(Optional Format 1-2-96)

Clim S. Lin

Sign-Off)
of Dental, Infection Control,
Hospital Devices
mber K993752