SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE
Device Facts
| Record ID | K072802 |
|---|---|
| Device Name | SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE |
| Applicant | Ultrawin Sdn Bhd |
| Product Code | LYY · General Hospital |
| Decision Date | Feb 29, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended Use
A non sterile powder free latex exam glove intended for medical purposes that is worn on the examiner's hands to prevent contamination between the patient and examiner.
Device Story
Single-use, disposable, blue-colored, powder-free latex patient examination glove. Coated with colloidal oatmeal USP. Designed to reduce protein content to 50 micrograms or less per gram of glove. Used by healthcare professionals in clinical settings to provide a protective barrier on the hands, preventing cross-contamination between patient and examiner.
Clinical Evidence
Bench testing only.
Technological Characteristics
Material: Natural rubber latex. Features: Powder-free, blue color, colloidal oatmeal USP coating. Protein content: ≤ 50 micrograms/gram. Form factor: Disposable examination glove. Sterilization: Non-sterile.
Indications for Use
Indicated for use as a non-sterile, powder-free latex examination glove for medical purposes to prevent cross-contamination between patient and examiner.
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
- K031414 — POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE · Perusahaan Getah Asas Sdn. Bhd. · Jun 26, 2003
- K991750 — BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN · Brightsway Holdings Sdn Bhd · Jun 23, 1999
- K994354 — POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) · Flexitech Sdn. Bhd. · Jan 31, 2000
- K993621 — HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC · Pamitex Industries Sdn Bhd · Dec 29, 1999
- K022815 — MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX · Pt. Smartglove Indonesia · Feb 13, 2003
Submission Summary (Full Text)
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Siew-Hoe Mah Ultrawin SDN BHD 12-A, Taman Ros Jalan Sultan Abdullah Teluk Intan, MALAYSIA 36000
FEB 2 9 2008
Re: K072802
Trade/Device Name: Single Use, Disposable, Blue Color, Powder Free Latex Patient Examination Glove with Colloidal Oatmeal USP with a Protein Claim of 50 Microgram or Less Per Gram of Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 13, 2008 Received: February 15, 2008
Dear Mr. Hoe Mah:
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. Hoe Mah
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 yours,
Chin Lin, Ph.D.
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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Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.
## INDICATIONS FOR USE STATEMENT
Applicant: ULTRAWIN SDN BHD
510(k) Number (if known): N/A
Device Name: SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP WITH A PROTEIN CLAIM OF 50 MICROGRAM OR LESS PER GRAM OF GLOVE
Indications For Use: A non sterile powder free latex exam glove intended for medical purposes that is worn on the examiner's hands to prevent contamination between the patient and examiner.
Prescription Use NO (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use YES (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)
Shula A. Murphy, K
(Division Sign. Org.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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