(46 days)
This Surgeon's glove is a device made of natural rubber intended to be worn by This Surgeon's glove to a so notect a surgical wound from contamination.
Sensiflex Plus, Polymer Coated Latex Surgical Glove Powder Free, Sterile, Coated with Aloe Vera, contains 50 micrograms or less of total water extractable protein per gram.
This document is a 510(k) premarket notification decision letter from the FDA for a surgical glove. It does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/software devices. The acceptance criteria for this type of device (surgical glove) are generally related to manufacturing standards, material properties, and sterility, which would be covered by general controls and specific standards for gloves.
Therefore, I cannot extract the requested information from this document. The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market the product.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2005
Mr. Low Chin Guan Managing Director Terang Nusa Sdn Bhd 1. Jalan 8 Pengkalan Chepa 2 Industrial Zone Kota Bharu, Kelantan MALAYSIA 16100
Re: K052837
Trade/Device Name: Sensiflex Plus, Polymer Coated Latex Surgical Glove Powder Free, Sterile, Coated with Aloe Vera, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: October 24, 2005 Received: November 3, 2005
Dear: Mr. Guan
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. Guan
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.
Annette Y. Michaux 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
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Indications for Use
510(k) Number (if known): K052837
Dovice Name: Sensiflex Plus, Polymer Coated Latex Surgical Glove Powder Free, Sterile, Serismex Flus, T Ulymer Goatos Editor St. 1997
Coated with Aloe Vera, contains 50 micrograms or less of total water extractable protein per gram.
Indications For Use:
multations I of GSC.
This Surgeon's glove is a device made of natural rubber intended to be worn by This Surgeon's glove to a so notect a surgical wound from contamination.
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shila A. Murphy, L.C. 1/15/15
(Nurse Sign-Off)
on of Anesthesiology, General Hospital, Sotion Control, Dental Devices
Page 6 of 28
Number: K 052837
§ 878.4460 Non-powdered surgeon's glove.
(a)
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.(b)
Classification. Class I (general controls).