POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2

K033564 · Kanam Latex Industries Pvt. , Ltd. · KGO · Feb 24, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033564
• Device Name: POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2
• Applicant: Kanam Latex Industries Pvt. , Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Feb 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Polymer coated, Powderfree Sterile Surgeon's Glove is to be worn by Operating Room Personnel to protect a Surgical Would from contamination.

Device Story

Powder-free, polymer-coated sterile latex surgeon's gloves; designed for use by operating room personnel; worn during surgical procedures to provide a barrier protecting surgical wounds from contamination; device acts as a physical barrier between the clinician's hands and the patient's surgical site.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Latex; polymer coated; powder-free; sterile; contains 50 micrograms or less of total water extractable protein per gram.

Indications for Use

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

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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2004

Mr. Ravi Abraham Managing Director Kanam Latex Industries Private Limited P.O. Box No. 28 Oopoottil Building, K.K. Road Kottayam - 686 001, Kerala, INDIA

Re: K033564

Trade/Device Name: Powder Free Latex Surgeon's Gloves Polymer Coated Sterile, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: February 3, 2004 Received: February 6, 2004

Dear Mr. Abraham:

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 approvisions 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 (1 Writ), it may be days of Federal Regulations, Title 21, Parts 800 to 898. In your deview to roublish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Abraham

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. or the Fiel of 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 und libing (21 cos i forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirely as 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) Fine reter 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj of and 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,

Chiu Lin, Ph., D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ENCLOSURE-II

## INDICATIONS FOR USE

| APPLICANT | KANAM LATEX INDUSTRIES PRIVATE LTD |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (K) NO | K033564 |
| DEVICE NAME | POWDERFREE LATEX SURGEON'S GLOVES<br>POLYMER COATED STERILE Contains<br>50 micrograms or less of Total water extractable protein per gram |

## INDICATIONS FOR USE.

The Polymer coated, Powderfree Sterile Surgeon's Glove is to be worn by Operating Room Personnel to protect a Surgical Would from contamination.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-C (21 CFR 807

| Counter Use | |
|--------------|-----------------------------------------|
| 7 Subpart C) | <div style="text-align:center;">✓</div> |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susanna Baruch

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices

510(k) Number

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