← Product Code [FYA](/productcode/FYA) · K061491 # LAC-MAC INNERBLOC O.R. GOWN (K061491) _Lac Mac, Ltd. · FYA · Aug 9, 2006 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K061491 ## Device Facts - **Applicant:** Lac Mac, Ltd. - **Product Code:** [FYA](/productcode/FYA.md) - **Decision Date:** Aug 9, 2006 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Indications for Use The Lac-Mac, Limited, InnerBloc® OR Surgical Gowns, based on the RePel Plus™ and GORE® Surgical Gown fabric materials, are intended to be worn by health care personnel in the operating room to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. For single use, the gowns are processed and packaged. ## Device Story InnerBloc® OR Surgical Gowns are protective apparel for operating room use. Designed to prevent cross-contamination of microorganisms, body fluids, and particulates between patients and healthcare staff. Fabric construction utilizes RePel Plus™ and GORE® materials. Gowns are provided as single-use, processed, and packaged items. Worn by surgeons, nurses, and OR staff during surgical procedures to maintain sterile field integrity and protect personnel from exposure to infectious agents. ## Clinical Evidence Bench testing only. ## Technological Characteristics Surgical gown constructed from RePel Plus™ and GORE® fabric materials. Designed as a barrier for infection control. Single-use, processed, and packaged. No electronic, software, or algorithmic components. ## Regulatory Identification Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded. ## Special Controls *Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. ## Reference Devices - RePel Plus™ (not specified) - GORE® Surgical Gown (not specified) ## 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}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG - 9 2006 Lac-Mac, Limited C/O Mr. Jeffrey O. Stull President International Personnel Protection, Incorporated P.O. Box 92493 Austin, Texas 78709 Re: K061491 Trade/Device Name: Lac-Mac, Limited, InnerBloc™ OR Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: May 30, 2006 Received: July 6, 2006 Dear Mr. Stull: 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 - Mr. Stull Please be advised that FDA's issuance of a substantial equivalence determination does not I icase oc advasod that 1211 o isbaniss on that your device complies with other requirements modifinal it Dri mas made and regulations administered by other Federal agencies. of the Act of ally I edelar statules and reguirements, including, but not limited to: registration 1 ou inust comply with an 07); labeling (21 CFR Part 801); good manufacturing practice and ilsuing (21 CFR Part 807), labelity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality of 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) I mis letter will anow you to begin mainers your substantial equivalence of your device to a premarket notified.com - The PDF 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), IT you desire specification is to your ce 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 other generational and Consumer Assistance at its toll-free Dribion of 01 01 01 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Suttle J. Mchcen Omd. 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 {2}------------------------------------------------ #### 510(k) Number (if known): K061491 ## Device Name: Lac-Mac, Limited, InnerBloc® OR Surgical Gowns #### Indications for Use: The Lac-Mac, Limited, InnerBloc® OR Surgical Gowns, based on the RePel Plus™ and GORE® Color Survice of the Art in the cours that are intended to be worn by health care The Lac-Mac, Limited, InnerBiolo OK Surgical Or his asse intended to be wort by health care LP Surgical Goven Pabric materials, are protect both the surgical patient world the operating room personnel from transfer of microorganisms, body filish, and patitulate matterial. For personnel from fransfer of of microolgamisms, "oody" history and processed and packaged. # (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) Elsh H. Murphy, MD 8/8/06 (Division Sign-Off Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K 061491 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) --- **Source:** [https://fda-staging.innolitics.com/device/K061491](https://fda-staging.innolitics.com/device/K061491) **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