POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM

K990501 · Flexitech Sdn. Bhd. · LYY · Apr 2, 1999 · General Hospital

Device Facts

• Record ID: K990501
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM
• Applicant: Flexitech Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Apr 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Powder-free natural, blue, and green latex examination gloves; designed for use by healthcare professionals during patient examinations. Primary function is to serve as a protective barrier to prevent cross-contamination between the examiner and the patient. Device features a protein content labeling claim of 50 micrograms or less. Used in clinical or medical settings; operated by physicians, nurses, or other healthcare personnel. Provides a physical barrier; reduces risk of pathogen transmission during routine clinical tasks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Natural rubber latex material; powder-free; available in natural, blue, and green colors. Protein content limited to 50 micrograms or less per glove. Form factor is a standard examination glove.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Suitable for general medical examination settings.

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

APR 2 1099

Mr. Kenny H. N. Liew Executive Director FLEXITECH SDN. SDN.BHD. Lot 5071, Batu 5 1/2 Jalan Meru, 41050 Klang, Selangor Darul Ehsan, MALAYSIA

Re : K990501 Powder-Free Natural, Blue, and Green Latex Trade Name: Examination Gloves With Protein Content Labeling Claim (50 Micrograms or Less) Requlatory Class: Product Code: LYY Dated: February 12, 1999 February 17, 1999 Received:

Dear Mr. Kenny H. N. Liew

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 Regulations, Title 21, Parts 800 to 895. ਜ 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 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 obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Kenny H. N. Liew

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,

Patutue Ciceraitzffer

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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## FLEXITECH SDN. BHD.

Company No: 165532 - M Lot 5071, Batu 5 1/2, Jalan Meru, 41050 Klang, Selangor, Malaysia. Tel: [phone]-Fax: [phone] NEW TEL: [phone] FAX : [phone]

## 3.0 Indications for Use Statement.

## Page 3 of 103

## INDICATIONS FOR USE

| Applicant : | FLEXITECH SDN BHD |
|----------------------|-------------------------------------------------------------------------------------------|
| 510(k) Number | K990501 |
| Device Name: | Powder Free Latex Examination Gloves, with protein labeling claim (50 micrograms or less) |
| Indication For Use : | |

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office Of Device Evaluation (ODE)

Olin S. Lin

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

scription Use Jr 21 CFR 801.109

Over-The-Counter : OR (Optional Format 1-2-96)