POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES
Device Facts
| Record ID | K052728 |
|---|---|
| Device Name | POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES |
| Applicant | M/S. Kanam Latex Industries Pvt. , Ltd. |
| Product Code | LYY · General Hospital |
| Decision Date | Dec 5, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended Use
A Powder Free Patient Examination Glove is a Disposable Device made of Natural Rubber Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Device Story
Disposable natural rubber latex examination glove; intended for use as a protective barrier against infectious materials and contaminants. Used in clinical or general medical settings by healthcare providers or patients. Device functions as a physical barrier; no electronic, mechanical, or software components. No clinical decision-making or automated analysis involved.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Material: Natural rubber latex. Form factor: Disposable examination glove. Sterile. No electronic components, software, or connectivity.
Indications for Use
Indicated for use as a disposable medical glove worn on the hands to provide a barrier against infectious materials and contaminants for patients and healthcare personnel.
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.
Related Devices
- K032938 — BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER · Brightway Holdings Sdn. Bhd. · Nov 20, 2003
- K032007 — GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR · Pt. Wrp Buana Multicorpora · Jul 28, 2003
- K090327 — POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE · Wear Safe (Malaysia) Sdn. Bhd. · Apr 3, 2009
- K111923 — SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE · Pt. Intan Hevea Industry · Nov 4, 2011
- K063581 — SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE · Pt Mahakarya Inti Buana · Mar 15, 2007
Submission Summary (Full Text)
{0}------------------------------------------------
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 a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
## Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 5 2005
Mr. Ravi Abraham Manager Director M/S. Kanam Latex Industries PVT. Limited Ooppoottil Buildings, K.K. Road Kottayam, Kerala India 686001
Re: K052728
Trade/Device Name: Powder Free Latex Sterile Patient Examination Gloves Regulation Number: 880. 6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 24, 2005 Received: November 30, 2005
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 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. 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. 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), please contact the Office 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/industry/support/index.html.
Sincerely vours.
Sophie J. Michael Omd.
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
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known): _ kos 2128
Device Name:POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES
Indications for Use:
A Powder Free Patient Examination Glove is a Disposable Device made of Natural Rubber
-Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Image /page/2/Picture/5 description: The image is a black and white drawing of an oval shape. The oval is not a perfect shape, and it has some irregularities. The oval is surrounded by a white background. The drawing is simple and does not contain any other details.
Pof Kanam Latax Indus Ltd. Ravi Abraham Mg. Director
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use. X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Fukui L. Kujay, M.D. 12/15/05
(Print Name)
West Anaheim Medical Center - General Hospital
Services
K052725
