← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K032467 # MAXTER STERILE POWDERED LATEX SURGICAL GLOVES (K032467) _Maxter Glove Manufacturing Sdn Bhd · KGO · Oct 10, 2003 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K032467 ## Device Facts - **Applicant:** Maxter Glove Manufacturing Sdn Bhd - **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md) - **Decision Date:** Oct 10, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4460 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery ## Intended 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. ## Device Story Sterile powdered latex surgical glove; disposable; made of natural rubber latex. Worn by operating room personnel during surgical procedures. Primary function: barrier protection to prevent contamination of surgical wounds. Device provides physical barrier between clinician hands and patient surgical site. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Material: natural rubber latex. Form factor: surgical glove. Sterile. Powdered. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K032467](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K032467) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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