STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)

K012880 · Ssn Gloves (M) Sdn Bhd · KGO · Nov 16, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012880
• Device Name: STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)
• Applicant: Ssn Gloves (M) Sdn Bhd
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Sterile powdered latex surgical gloves; intended for use by operating room personnel; primary function is barrier protection to prevent contamination of surgical wounds. Device consists of natural rubber latex; features protein labeling claim of 50 micrograms or less. Used in surgical settings to maintain sterile field and protect both patient and clinician.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Natural rubber latex surgical glove; sterile; powdered; protein content labeled at 50 micrograms or less. Class I device under 21 CFR 878.4460.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. No specific patient population, age, or gender restrictions provided.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with three stripes representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2001

Mr. Clinton A. Teck Leong Managing Director SSN Glove (M) Sdn Bhd No. 1, Jalan 203, Off Jalan Tandang Petaling, Jala Selangor, MALAYSIA

Re: K012880

Trade/Device Name: Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim ( 50 Micrograms or Less ) Regulation Number: 878.4460 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: KGO Dated: August 23, 2001 Received: August 28, 2001

Dear Mr. Leong:

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.

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## Page 2 - Mr. Leong

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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 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 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 the Act may be obtained 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,

Ky Kilatrick

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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## 3.0 Indications for Use Statement:

| NOV 1 6 2001 | INDICATIONS FOR USE | |
|--------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | : | SSN Gloves (M) Sdn Bhd |
| 510(k) Number | : | K012880 |
| Device Name | : | Sterile Powder Free Latex Surgical Gloves with Protein<br>Labeling Claim ( 50 micrograms or less ) |
| Indication For Use | : | A surgeon's glove is a device made of natural or synthetic<br>rubber intended to be worn by operating room personnel<br>to protect a surgical wound from contamination. |

Section 3 - Page 1 of 1

Olen S. Lin

(Division Sign-Off) Covision of Dental, Infection Control, and General Hospital Devices ் : 0(x) Number J 0

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