← Product Code [LZA](/productcode/LZA) · K021452 # STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE (K021452) _Maxxim Medical · LZA · Aug 1, 2002 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K021452 ## Device Facts - **Applicant:** Maxxim Medical - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Aug 1, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. ## Device Story Sterile SensiCare® Advantix™ is a powder-free, polyurethane medical/dental examination glove. Device serves as a protective barrier worn on examiner's hands to prevent contamination between patient and examiner. Manufactured from polyurethane polymer with polyurethane coating on user side to facilitate donning and doffing without powder. Available in various sizes; provided in sterile packaging (single or pair). Used in clinical and dental settings by healthcare professionals. Device functions as a physical barrier; no electronic or mechanical components. Benefits include reduced risk of cross-contamination and avoidance of powder-related sensitivities. ## Clinical Evidence Bench testing only. Gloves tested for physical properties and dimensions per ASTM D 3578-01a, freedom from holes, and powder-free status per ASTM D 6124-01. Biocompatibility testing (non-irritating, non-sensitizing) performed per ISO 10993-Part 10. ## Technological Characteristics Material: Polyurethane polymer with polyurethane coating. Powder-free. Sterile. Dimensions and physical properties meet ASTM D 3578-01a. Biocompatibility per ISO 10993-10. No electronic components or software. ## Regulatory Identification A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing. ## Predicate Devices - SensiCare™ Advantix™ Medical/Dental Examination Glove ([K011198](/device/K011198.md)) ## 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/0 description: The image shows the logo for Maxxim Medical. The logo is in black and white and features the word "MAXXIM" in large, bold letters. Below the word "MAXXIM" is the word "MEDICAL" in smaller letters. The logo is simple and modern. K021452 510(K) Submission: Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/ Dental Examination Glove AUG 01 2002 # Attachment 4 ## Summary of Safety and Effectiveness Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove | Classification: | Class 1 | |----------------------|----------------------------------------------------------------| | Panel: | Classification by the General Hospital and Personal Use Device | | Common Name: | Medical Examination Gloves | | | Dental Examination Gloves | | Classification Name: | Patient Examination Glove (21 CFR 880.6250) | The purpose of this 510(k) is to obtain an FDA clearance for manufacturing, importing and distributing a sterile, powder-free, polyurethane examination glove. The Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove is substantially equivalent to the SensiCare™ Advantix™ Medical/Dental Examination Glove, originally cleared under K 011198. The results of the safety, efficacy and performance testing of the Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove are submitted in this 510(k) application and are summarized as follows: - The gloves meet all ASTM D 3578-01a requirements for freedom from holes, physical 1 . properties and physical dimensions, except ultimate elongation before aging. They meet the same requirements as the gloves cleared under K011198. - 2. The gloves have been tested and have been shown to be non-irritating and non-sensitizing when tested in accordance with ISO 10993-Part 10. - 3. The gloves meet requirements of ASTM-6124-01 for labeling as powder free. No powders are utilized in the manufacturer of this glove. - The glove is manufactured using the same polymer materials as described in K011198. 4. The product is a powder-free, sterile, polyurethane examination glove that is available in various sizes. It is made with a polyurethane polymer and polyurethane coating on the user side. This coating provides good donning and doffing without the use of donning powder. No release powder or chemical release agents are used. The gloves will be marketed both as medical examination gloves and dental examination gloves. All requirements for physical properties and dimensions have been met for such uses, based upon comparisons to the predicate devices. There are no adverse changes to the safety and efficacy of the glove products in this submission. The only difference in the proposed glove will be the addition of the sterilization process and the change in packaging (single, pair vs. 100 count/box). Each product will be manufactured to the specifications and per documented label claims in K011198. --- Signature of Certifier 4/30/02 --- Date Julio Gonzalez Typed Name 4750 118th Avenue North · Clearwater, FL 33762 {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. ### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Julio Gonzalez Director Quality Assurance Maxxim Medical 4750 118" Avenue North Clearwater, Florida 33762 Re: K021452 Trade/Device Name: Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: June 30, 2002 Received: July 3, 2002 Dear Mr. Gonzalez: 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 vour 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. 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. {2}------------------------------------------------ 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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours, Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(K) Submission: Sterile SensiCare® Advantix™ Powder Free Polyurethane Medical/Dental Examination Glove ## Indications for Use | Applicant: | Maxxim Medical, Inc. | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number (if known): | K021452 | | Device Name: | Sterile SensiCare® Advantix™ Powder Free Polyurethane
Medical/Dental Examination Glove | | Indications for Use: | A patient examination glove is a disposable device intended
for medical purposes that is worn on the examiner's hand to
prevent contamination between patient and examiner. | # (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 (Optional Format 1-2-96) 4750 118th Avenue North . Clearwater, FL 33762 Quta Sahn Page 6 | vision Sign-Off) | | |--------------------------------------|---------| | vision of Dental, Infection Control, | | | General Hospital Devices | | | 510(k) Number | K021452 | --- **Source:** [https://fda-staging.innolitics.com/device/K021452](https://fda-staging.innolitics.com/device/K021452) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com