GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS

K993725 · Hartalega Sdn Bhd · LYY · Nov 23, 1999 · General Hospital

Device Facts

• Record ID: K993725
• Device Name: GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
• Applicant: Hartalega Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Nov 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Device Story

Disposable latex examination gloves; intended for medical and dental use; worn by healthcare personnel to provide barrier protection against cross-contamination. Device features protein content labeling claim of 50 micrograms or less. Used in clinical and dental settings to protect both patient and provider.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and compliance with established standards for medical examination gloves.

Technological Characteristics

Material: Latex. Form factor: Powder-free examination glove. Feature: Protein content labeling claim (≤ 50 micrograms).

Indications for Use

Indicated for use by healthcare and dental personnel as a disposable barrier to prevent cross-contamination between the wearer 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

NOV 2 3 1999

Ms. Nurul Aisyah Kong Quality Assurance Manager Hartalega Sdn. Bhd. 9, Jalan Kuang Bulan Taman Kepong Industrial Estate 52100 Kuala Lumpur, Malaysia

Re : K993725 Green Chlorinated Powder Free Latex Trade Name: Examination Gloves (With Protein Labeling Claim) Requlatory Class: I Product Code: LYY Dated: October 29, 1999 November 3, 1999 Received:

Dear Ms. Kong:

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 aqainst 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. ਰ 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

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Page 2 - Ms. Kong

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 requlation (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 compriated 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" (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,

U.J. Qulatrust

Timothy R. 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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## INDICATIONS FOR USE

HARTALEGA SDN. BHD. Applicant :

510(k) Number (if known) :

Device Name : Green Chlorinated Powder Free Latex Examination Gloves With Protein Content Labeling Claim of 50 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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

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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) |

| (Division Sign-Off) | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K993725 |