HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES

K993201 · Pamitex Industries Sdn Bhd · KGO · Mar 29, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K993201
• Device Name: HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES
• Applicant: Pamitex Industries Sdn Bhd
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Mar 29, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A sterile power-free latex surgeon's glove is a disposable device intended for medical purpose that is worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Sterile powder-free latex surgical gloves; disposable; worn by operating room personnel. Function: physical barrier to prevent contamination of surgical wounds. Used in surgical settings to maintain sterile field and protect patient from clinician-borne contaminants and vice versa.

Clinical Evidence

No clinical data provided; device relies on established material properties and manufacturing standards for surgical gloves.

Technological Characteristics

Material: Latex. Form factor: Sterile, powder-free surgical glove. Disposable. Manufacturing: Compliant with 21 CFR Part 820 (GMP).

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination during medical procedures.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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 2 9 2000

Mr. Said Awang Product Development & Technical QA Pamitex Industries Sdn. Bhd. Batu 2½, Jalan Rasah 70300 Seremban, Negeri Sembilan Darul Khusus MALAYSIA

каяз201 Re : Health-Plus, Sanitex, Reliance Powder-Free Trade Name: Sterile Latex Surgical Gloves Regulatory Class: I KGO Product Code: February 29, 2000 Dated: March 8, 2000 Received:

Dear Mr. Awang:

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. ಕ 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

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## Page 2 - Mr. Awang

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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compriation and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene regaracion " (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

Timothy A. Ulatowski

Tin othy A. Ulatows Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) NUMBER (IF KNOWN):

K 993201

## DEVICE NAME: Sterile Powder-Free Latex Surgical Gloves

## INDICATIONS FOR USE:

A sterile power-free latex surgeon's glove is a disposable device intended for medical purpose that is worn by operating room personnel to protect a surgical wound from contamination.

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

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Division of Dental, Infection Control,
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