LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE

K014087 · Latexx Manufacturing Sdn.Bhd. · LYY · Mar 4, 2002 · General Hospital

Device Facts

• Record ID: K014087
• Device Name: LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE
• Applicant: Latexx Manufacturing Sdn.Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Mar 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Non-chlorinated Power Free Natural Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hands of the healthcare personnel to prevent contamination between the healthcare personnel and the patient.

Device Story

Device is a single-use, non-chlorinated, polymer-coated, powder-free natural rubber latex examination glove. Used by healthcare personnel in clinical settings as a protective barrier to prevent cross-contamination between the wearer and the patient. Device functions as a physical barrier; no electronic or mechanical components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Natural rubber latex. Features: Non-chlorinated, polymer-coated, powder-free. Form factor: Examination glove. Energy source: None. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for use by healthcare personnel as a single-use protective 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

MAR 4 2002

Latexx Manufacturing Sdn. Bhd. C/O Ms. Yolanda Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114

Re: K014087

Trade/Device Name: Latexx Manufacturing Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 11, 2001 Received: December 11, 2001

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

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of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I occeral bars sure quirements, including, but not limited to: registration 1 ou must comply with a807); labeling (21 CFR Part 801); good manufacturing practice and instill (21 es rear of the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 1 mis letter will and w you to began maint and 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 If you debare opening 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under nouthout (D. C. C. I I a from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/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

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## 510(k) Number (if known): KOI 4087

## Device Name: Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber
Coated, Polymer Coated, Co Latex Examination Glove

Classification Panel: 80LYY

Indications for Use:

Non-chlorinated Power Free Natural Rubber Examination Glove is a single use device Non-chornated Powel Free Natural International of the healthcare and similar intended for medical purposes that is work on the hass of the patient.
personnel to prevent contamination between the healthcare personnel and the patient.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ____________________________ |
|------------------|--------------------------------------------------|
| or | Over-the Counter Use____________________________ |

| (Division Sign-Off) | |
|----------------------------------------|---------|
| Division of Dental, Infection Control, | |
| General Hospital Devices | |
| 510(k) Number | K014087 |