COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES

K993864 · Supermax Sdn Bhd · LYY · Jan 20, 2000 · General Hospital

Device Facts

• Record ID: K993864
• Device Name: COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
• Applicant: Supermax 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 powder free patient examination glove is a disposable device made of latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.

Device Story

Device is a disposable, powder-free latex examination glove. Intended for use by healthcare professionals to provide a protective barrier against infectious materials and contaminants during medical examinations. Manufactured with a protein content labeling claim of 50 micrograms or less. Device is non-sterile and intended for single use.

Clinical Evidence

No clinical data provided; substantial equivalence based on device design and intended use as a standard latex examination glove.

Technological Characteristics

Material: Latex. Form factor: Powder-free examination glove. Protein content: 50 micrograms or less. Single-use, disposable.

Indications for Use

Indicated for use as a disposable, powder-free latex barrier worn on the hands or fingers by healthcare personnel to prevent cross-contamination between patient and examiner.

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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Image /page/0/Picture/1 description: The image is a black and white circular logo. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'. The text is arranged along the circumference of the circle, with the bird image positioned in the center.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050

JAN 2 0 2000

Mr. Stanley Thai Managing Director Supermax Glove Manufacturing SDN. BHD. Lot 42, Putra Industrial Park Bukit Rahman Putra 47000 Sungai Buloh Selangor Darul Ehsan. Malaysia

K993864 Re : Green Peppermint Flavored Powder Free Latex Trade Name: Examination Gloves with Protein Content Labeling Claim (50 micrograms or less) Regulatory Class: I LYY Product Code: November 11, 1999 Dated: November 15, 1999 Received:

Dear Mr. Thai:

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 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 (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. ਸੈ 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

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Page 2 - Mr. Thai

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 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 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.fdalgov/cdrh/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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Enclosure

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## 510 (k) NUMBER (IF KNOWN) : KG9 3864

## DEVICE NAME GREEN PEPPERMINT FLAVORED POWDER FREE LATEX EXAMINATION WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE:

INDICATIONS FOR USE :

A powder free patient examination glove is a disposable device made of latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use **__** OR Over-The-Counter- Use

(per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off
Division of Dental Infection Control,
and General Hospital Devices
510(k) Number K993864

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