POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E

K042567 · Pt. Medisafe Technologies · KGO · Jan 13, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K042567
• Device Name: POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E
• Applicant: Pt. Medisafe Technologies
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jan 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Powder-Free, Polychloroprene Surgical Gloves with Vera and Vitamin E, Sterile _ 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, powder-free surgical glove composed of synthetic polychloroprene; coated with Aloe Vera and Vitamin E. Intended for use by operating room personnel to provide a protective barrier between the clinician and the surgical wound, preventing cross-contamination. Device functions as a physical barrier; worn on hands during surgical procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Synthetic polychloroprene. Features: Powder-free, sterile, coated with Aloe Vera and Vitamin E. Form factor: Surgical glove. No software or electronic components.

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)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird in flight, composed of three curved lines.

Public Health Service

JAN 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Anil Taneja Vice President PT. Medisafe Technologies JL. Batang Kuis, Gg. Tambak Rejo, Pasar IX Desa Buntu Bedimbar, Tanjung Morawa-20362 Medan-Sumatera Utara INDONESIA

Re: K042567

Trade/Device Name: Synthetic Polychloroprene Surgical Glove with Aloe Vera and Vitamin E, Sterile Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: November 24, 2004 Received: November 29, 2004

Dear Mr. Taneja:

We have reviewed your Section 510(k) premarket notification of intent to market the device we mayo roverved your betermined 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 mersule commerce prior sthat have been reclassified in accordance with the provisions of Amendinens, or to are roses and Cosmetic Act (Act) that do not require approval of a premarket the Federal I 600; Drag, Drag, therefore, market the device, subject to the general approvin uppression (s) the Act. The general controls provisions of the Act include controls provisions of the Fish - 110 - Jisting 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 If your device is classinod (oos as olditional controls. Existing major regulations affecting (1 Mrs), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

## Page 2 - Mr. Taneja

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease to advace that 22 a determination that your device complies with other requirements moan that I Dr may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I outhar statuse the requirements, including, but not limited to: registration r ou inton compry war 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 OF read 001), systems (QS) regulation (21 CFR Part 820); and if requirences as set forth in the quality sion 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) I mis letter will and in yourse 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), 11 you don't 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 overn 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,

Qurs

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): K042567

Device Name: Powder-Free, Polychloroprene Surgical Gloves with Aloe Vera and Vitamin E, Sterile

Indications For Use:

The Powder-Free, Polychloroprene Surgical Gloves with Vera and Vitamin E, Sterile _ is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suste Michain DMD.

sion of Anesthesiology, Gene Infection Control, Dental D

510(k) Number