(114 days)
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.
Not Found
This appears to be a 510(k) clearance letter from the FDA for a surgical glove. The provided text does not contain any information about acceptance criteria, study details, or device performance data.
The document primarily focuses on:
- Device Identification: Trade/Device Name, Regulation Number, Regulatory Class, Product Code.
- FDA Clearance: Confirmation of substantial equivalence to a predicate device.
- Regulatory Information: General controls provisions, potential additional controls, contact information for regulatory guidance.
- Indications for Use: Stating the purpose of the surgical gloves (protection of a surgical wound from contamination).
Therefore, I cannot provide the requested table and study details based on the given input. To answer your request, I would need a document that includes performance data for the device, such as a summary of safety and effectiveness (SSE) report or a clinical study report that details the testing performed to demonstrate the device meets certain criteria.
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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.
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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 (301) 594-0115. 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 maj overn 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,
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
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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
§ 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).