(55 days)
A powder-free sterile surgeon's glove is a disposable device made of latex that is worn on the hands, usually in surgical settings, to provide a barrier between the wearer and/or the patient and the surgical environment, and to prevent contamination between the patient and the wearer.
A powder-free sterile surgeon's glove is a disposable device made of latex that is worn on the hands, usually in surgical settings, to provide a barrier between the wearer and/or the patient and the surgical environment, and to prevent contamination between the patient and the wearer.
This document is a 510(k) premarket notification decision letter from the FDA for surgical gloves. It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.
The letter pertains to the "Eclipse Latex Powder Free Sterile Surgeon's Glove" and primarily confirms its substantial equivalence to previously marketed predicate devices under the 510(k) process. This is a regulatory pathway for medical devices that are similar to existing ones and does not typically involve detailed performance studies with acceptance criteria as would be expected for a novel AI/ML device.
Therefore, I cannot provide the requested information from the given text.
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Public Health Service
APR 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathleen Harris Global Regulatory Manager Regent Medical Americas, LLC 3585 Engineering Drive, Suite 250 Norcross, Georgia 30092
Re: K050533
Trade/Device Name: Eclipse Latex Powder Free Sterile Surgeon's Glove Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: March 31, 2005 Received: April 7, 2005
Dear Ms. Harris:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally a see ice is substantially equivalent (for the referenced above and nave determinou re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate connineree proct to that have been reclassified in accordance with the provisions of Amendinents, or to de rises that in to Act (Act) that do not require approval of a premarket the rederal I ood, Drug, and Comers , therefore, market the device, subject to the general approvin appreation (the Act. The general controls provisions of the Act include controls provisions of the Fea. " Insting 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 classified (see as 107.0) in the such and or regulations affecting (PMA), it may of subject to sach adam Regulations, Title 21, Parts 800 to 898. In your device can be found in the Court in the Courcements concerning your device in the Federal Register.
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Page 2 - Ms. Harris
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DTC issumes on that your device complies with other requirements mean that I DA has made a aves and regulations administered by other Federal agencies. of the Act of ally I oderal but sequirements, including, but not limited to: registration r out must comply with an the Fiel s rig (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 067), laceling systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality spotsions (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) This letter will anon your be began finding of substantial equivalence of your device to a premiarket notification. - The Fire 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), If you desire specific advice to: Jour 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 may obtain 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,
Smitte Michian Crnit
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):
Device Name: Eclipse latex powder free sterile surgeon's glove
Indications For Use:
A powder-free sterile surgeon's glove is a disposable device made of latex that is A power of co sterile but chands, usually in surgical settings, to provide a barrier the new a or ou never ous materials and other contaminants.
Prescription Use · (Part 21 CFR 801 Subpart D) Over-The-Counter Use_ × (21 CFR 801 Subpart C)
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AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shila H. Migday 42
insion Sign-Off) Civision of Anesthesiology General Hospital, Infection Control, Dental Devices
c10(k) Number: K050533
§ 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).