← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K022873 # POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK) (K022873) _International Biomedical, Inc. · KGO · Mar 21, 2003 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K022873 ## Device Facts - **Applicant:** International Biomedical, Inc. - **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md) - **Decision Date:** Mar 21, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4460 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery ## Intended Use A powder-free surgeon's glove is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious materials and other contaminants. Additionally, the radiation attenuating surgical glove is intended to be used during medical procedures where hands are necessarily exposed to radiation in order to offer some degree of protection to the hand from radiation. This includes surgical procedures that require the use of fluoroscopy or radiography. ## Device Story Powder-free surgical glove formulated from neoprene synthetic latex; designed to provide a barrier against infectious materials and attenuate radiation exposure to the clinician's hands. Used in surgical settings, specifically during fluoroscopy or radiography procedures. Provides protection to the wearer's hands from ionizing radiation; serves as a standard surgical barrier. No electronic components or software. ## Clinical Evidence Bench testing only. Testing included primary skin irritation and dermal sensitization (no potential displayed), elongation and tensile strength (ASTM D 3577-01a), barrier defects (ASTM D 3577-01a), and powder levels (ASTM D 6124-01). ## Technological Characteristics Material: Neoprene synthetic latex. Form factor: Powder-free surgical glove. Standards: ASTM D 3577-01a (tensile strength, elongation, barrier defects), ASTM D 6124-01 (powder levels). Sterilization: Sterile. ## 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. ## Predicate Devices - Radiation Attenuating Surgical Glove by International Biomedical, Inc. (82k1720) - ESP Radiation Recustion Examination Gloves by Boston Scientific (k891968) - BarrierPlus Synthetic Powder-Free Surgical Gloves by BarrierMed Glove Company (k990710) ## 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 logo for International Biomedical, Inc. The logo features a stylized letter "i" on the left, followed by the company name in bold, sans-serif font. Below the company name is the address, 8508 Cross Park Dr. MAR 21 2003 8508 Cross Park Dr. Austin, Texas 78754 512-873-0033 Fax: 512-873-9090 www.int-bio.com # 5404) STATEMENT OF SAFETY AND EFFECTIVENESS ### 510k SUMMARY OF SAFETY AND EFFECTIVENESS RADIATION ATTENUATING SURGICAL GLOVE | Manufacturer: | International Biomedical, Inc.
8508 Cross Park Drive
Austin, TX 78754
U.S.A. | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Affairs Contact: | Amy Pieper
8508 Cross Park Dr.
Austin, TX 78754 | | Telephone: | (512) 873-0033 | | Date Summary Prepare: | August 27, 2002 | | Common Name: | Powder-Free Radiation Attenuating Surgical Glove | | Classification: | Sugeon's Glove, 79KGO | | Predicate Devices: | Radiation Attenuating Surgical Glove by International Biomedical,
Inc. (82k1720) and the ESP Radiation Recustion Examination
Gloves by Boston Scientific (k891968) and BarrierPlus Synthetic
Powder-Free Surgical Gloves y BarrierMed Glove Company
(k990710). | | Description: | The Powder-Free Radiation Attenuating Surgical Gloves are
formulated using neoprene, synthetic latex. The gloves are
supplied powder-free and sterile. | | Intended Use: | A powder-free surgeon's glove is intended to be worn on the
hands, usually in a surgical setting, to provide a barrier against
potentially infectious materials and other contaminants.
Additionally, the radiation attenuating surgical glove is intended to | {1}------------------------------------------------ | | be used during medical procedures where hands are necessarily
exposed to radiation in order to offer some degree of protection to
the hand from radiation. This includes surgical procedures that
require the use of fluoroscopy or radiography. | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial Equivalence: | Powder Free Radiation Attenuating Surgical gloves are
substantially equivalent to the Radiation Attenuating Surgical
Gloves in that they have the same intended use, they are both made
of synthetic latex, and they are both manufactured in the same way.
The Powder Free Radiation Attenuating Surgical gloves are
substantially equivalent to the ESP Radiation Recustion
Examination Gloves by Boston Scientific in that they have the
same intended use and polymers.
The Powder Free Radiation Attenuating Surgical gloves are
substantially equivalent to the BarrierPlus Synthetic Powder-Free
Surgical Gloves in intended use, design and product features, and
physical characteristics. | | Summary of Test Results:
Test | Result | | Primary Skin Irritation | Glove does not display irritation potential. | | Dermal Sensitization | Glove does not display sensitization potential. | | Elongation and Tensile
Strength | Glove meets or exceeds requirements for synthetic surgical gloves
per ASTM D 3577-01a. | | Barrier Defects | Glove meets or exceeds requirements per ASTM D3577-01a. | | Powder Level | Glove meets powder level requirements for "Powder Free"
designation per ASTM D 6124-01. | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 1 2003 Ms. Amy Pieper Regulatory Affairs International Biomedical, Incorporated 8508 Cross Park Drive Austin, Texas 78754 Re: K022873 Trade/Device Name: Radiation Attenuating Neoprene Surgical Gloves, Powder Free (Black) Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: November 25, 2002 Received: January 21, 2003 Dear Ms. Pieper: 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. {3}------------------------------------------------ Page 2 - Ms. Pieper 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 (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), 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 yours, Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## 510k SUBMISSION FOR THE RADIATION ATTENUATING SURGICAL GLOVE (BLACK) #### INDICATIONS FOR USE Applicant's Name: International Biomedical, Inc. **510(k) Number:** K022873 Neoprene Device Name: Radiation Attenuating Surgical Gloves , C Power Free (BLACK) #### Indications for Use: A powder-free surgeon's glove is a device made of synthetic latex that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. The radiation attenuating surgical glove is intended to be used during medical procedures where hands are necessarily exposed to radiation in order to offer some degree of protection to the hand from radiation. This includes surgical procedures that require the use of fluoroscopy or radiography. Clin S. him (Division Sign-Off) sion of Anesthesiology, General Hospital Infection Control, Dental De 510(k) Number: K022823 Image /page/4/Picture/12 description: The image shows the logo for International Biomedical, Inc. The logo consists of a stylized lowercase "i" on the left, followed by the words "International Biomedical, Inc." on the right. The "i" is a bold, black color, and the text is also black. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K022873](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K022873) **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