(60 days)
A Sterile Powdered Latex Surgical Glove is a disposable device made of natural rubber latex and is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Sterile Powdered Latex Surgical Gloves
The provided document is an FDA 510(k) clearance letter for "Maxter Sterile Powdered Latex Surgical Gloves." This document does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.
The document pertains to a medical device (surgical gloves) that undergoes a different type of regulatory review than AI/ML software. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, primarily based on its materials and intended use, rather than performance metrics derived from complex data analysis.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) from this document. This kind of information is typically found in premarket submission summaries for AI/ML devices, not for basic medical consumables like surgical gloves.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2003
Ms. Priscilla Wee Senior Manager Regulatory Affairs Maxter Glove Manufacturing SDN BHD Lot 6070 Jalan Haji Abdul Manan, 6th Miles Off Jalan Meru, 41050 Klang Selangor, MALAYSIA
Re: K032467
Trade/Device Name: Maxter Sterile Powdered Latex Surgical Gloves Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: July 28, 2003 Received: September 4, 2003
Dear Ms. Wee:
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 - Ms. Wee
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely vours.
CluLs
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
| Applicant : | Maxter Glove Manufacturing Sdn. Bhd. |
|---|---|
| 510 (k) Number (if known) : | K032467 * |
| Device Name : | Sterile Powdered Latex Surgical Gloves |
Indications For Use :
A Sterile Powdered Latex Surgical Glove is a disposable device made of natural rubber latex and is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Patrice By Chander
(Division Sign Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 OR Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
- For a new submission, do NOT fill in the 510(k) number blank.
§ 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).