K042898 · Glovco (M) Sdn. Bhd. · LZA · Jan 18, 2005 · General Hospital
Device Facts
Record ID
K042898
Device Name
PANTHERA N POWDER FREE BLACK NITRILE GLOVES
Applicant
Glovco (M) Sdn. Bhd.
Product Code
LZA · General Hospital
Decision Date
Jan 18, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.6250
Device Class
Class 1
Indications for Use
A powder-free patient examination glove (nitrile) is a disposable device made of synthetic material (nitrile latex) that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and ntoal paiminants. The glove is black with a carbon black colorant additive and polymer coated.
Device Story
Disposable patient examination glove; synthetic nitrile latex material; black colorant additive; polymer coated. Used by healthcare professionals to provide a barrier against infectious materials and contaminants during medical examinations. Device is non-sterile, single-use, and worn on hands or fingers.
Clinical Evidence
Bench testing only.
Technological Characteristics
Material: Synthetic nitrile latex; carbon black colorant; polymer coated. Form factor: Disposable examination glove. Energy source: None. Sterilization: Not specified.
Indications for Use
Indicated for use as a disposable patient examination glove worn on hands or fingers to provide a barrier against infectious materials and contaminants. Suitable for general medical use.
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)
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three stripes resembling an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2005
Mr. Tan Peng Hock Managing Director Glovco (M) SDN BHD Lot 760, Jalan Haji Sirat, 42100 Klang, Selangor Darul Ehsan, MALAYSIA
Re: K042898
Trade/Device Name: Powder-Free, Black, Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 31, 2004 Received: January 10, 2005
Dear Mr. Hock:
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.
{1}------------------------------------------------
Page 2 - Mr. Hock
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 that I Dr Has Intacted and regulations administered by other Federal agencies. You must or any 1 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 CI K Fut 6077; facemig (21 (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. product indiation of to begin marketing your device as described in your Section 510(k) I mo letter notification. The FDA finding of substantial equivalence of your device to a legally premated 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 if you active of Compliance at (240) 276-0115. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known): K042898
Device Name: POWDER-FREE, BLACK, NITRILE EXAMINATION GLOVES
Indications For Use: A powder-free patient examination glove (nitrile) is a disposable device made of synthetic material (nitrile latex) that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and ntoal paiminants. The glove is black with a carbon black colorant additive and polymer coated.
Songate Michin Oms.
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
