← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K150146 # Biogel PI Micro Indicator Underglove (K150146) _Molnlycke Health Care Us, LLC · KGO · Aug 31, 2015 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K150146 ## Device Facts - **Applicant:** Molnlycke Health Care Us, LLC - **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md) - **Decision Date:** Aug 31, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4460 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery ## Intended Use The Biogel® PI Micro Indicator Underglove is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. ## Device Story Disposable, sterile, powder-free surgical underglove; manufactured from synthetic polyisoprene; blue color. Worn on hands by surgeons/clinical staff in surgical settings to provide barrier protection against infectious materials and contaminants. Device functions as a physical barrier; no electronic or mechanical components. Intended to mitigate risk of cross-contamination between patient and clinician. ## Clinical Evidence No clinical data. Substantial equivalence supported by bench testing including biocompatibility (ISO 10993-10), physical dimensions/properties (ASTM D3577), freedom from holes (ASTM D5151), and powder residual (ASTM D6124). ## Technological Characteristics Material: Synthetic polyisoprene. Design: Single-use, sterile, powder-free, hand-specific, beaded cuff. Sterilization: Radiation (SAL 10^-6). Standards: ASTM D3577 (dimensions, physical properties, powder residual), ASTM D5151 (freedom from holes), 21 CFR 800.20 (AQL). ## 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 - Biogel® PI Indicator® Underglove ([K111413](/device/K111413.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/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, possibly representing health and well-being. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 31, 2015 MÖLNLYCKE HEALTH CARE US, LLC Ms. Megan Bevill Manager, Regulatory Affairs 5550 Peachtree Parkway, Suite 500 Norcross. GA 30092 Re: K150146 Trade/Device Name: Biogel® PI Micro Indicator Underglove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's glove Regulatory Class: I Product Code: KGO Dated: July 31, 2015 Received: August 4, 2015 Dear Ms. Bevill: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Bevill 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, *Tejashri Purohit-Sheth, M.D.* Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K150146 Device Name Biogel® PI Micro Indicator Underglove Indications for Use (Describe) The Biogel® PI Micro Indicator Underglove is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) |X Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) SUMMARY This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92(c). | Date Prepared: | July 31, 2015 | | | |------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Applicant: | Mölnlycke Health Care US, LLC
5550 Peachtree Parkway, Suite 500
Norcross, GA 30092
Registration number: 3004763499
Owner/Operator Number: 8030877 | | | | Official Correspondent: | Megan Bevill
Manager, Regulatory Affairs
Tel: 470-375-0049
Fax: 678-245-7746
email: megan.bevill@molnlycke.com | | | | Trade/Proprietary Names: | Biogel® PI Micro Indicator Underglove | | | | Regulation Name: | Surgeon's Glove | | | | Device Class: | Class I | | | | Regulation Number: | 21 CFR 878.4460 | | | | Product Code: | KGO | | | | Predicate Device Name(s): | Biogel® PI Indicator® Underglove (K111413) | | | | | Biogel® PI Micro Indicator
Underglove | Biogel® PI Indicator®
Underglove | | | 510(k) clearance | K150146 | K111413 | | | Manufacturer | Mölnlycke | Mölnlycke | | | Regulation number | 21CFR 878.4460 | 21CFR 878.4460 | | | Regulation name | Surgeon's Glove | Surgeon's Glove | | | Regulatory class | Class 1 | Class 1 | | | Product code | KGO | KGO | | | Intended use | Powder-Free Surgeon's Glove | Powder-Free Surgeon's Glove | | | Indication for use | Biogel® PI Micro Indicator
Underglove is a disposable device
made of polyisoprene, blue in
color, that is intended to be worn
on the hands, usually in surgical
setting, to provide a barrier against
potentially infectious material and
other contaminants. | Biogel® PI Indicator® Underglove
is a disposable device made of
polyisoprene, blue in color, that is
intended to be worn on the hands,
usually in surgical setting, to
provide a barrier against
potentially infectious material and
other contaminants. | | | Material | Synthetic Polyisoprene | Synthetic Polyisoprene | | | Design | Single use | Single use | | | | Sterile | Sterile | | | | Powder-free | Powder-free | | | | Hand specific | Hand specific | | | | Beaded cuff | Beaded cuff | | | Coating | No | Yes | | | Colour | Blue | Blue | | | Sterilisation method | Radiation | Radiation | | | Sterility Assurance
Level (SAL) | 10 -6 SAL | 10 -6 SAL | | | Dimensions & physical
properties | Meets ASTM D3577 | Meets ASTM D3577 | | | Freedom from holes | AQL meets 21 CFR 800.20 and
ASTM D3577 requirements | AQL meets 21 CFR 800.20 and
ASTM D3577 requirements | | | Powder residual | Meets requirements of ≤ 2.0
mg/glove for Powder-free
designation per ASTM D3577 | Meets requirements of ≤ 2.0
mg/glove for Powder-free
designation per ASTM D3577 | | | Performance Test Data Summary - Subject Device (modified version of the predicate) | | | | | | Standard/Test/FDA Guidance | Results Summary | | | Biocompatibility : | | | | | Primary Skin Irritation | ISO 10993-10 | Under the conditions of the study, not an irritant. | | | ISO Closed Patch
Sensitization | ISO 10993-10 | Under the conditions of the study,
not a sensitizer. | | | Physical
characteristics :
Dimensions | ASTM D3577 | Meets ASTM D3577 requirements
for length, width, and thickness | | | Physical Properties | ASTM D3577 | Meets ASTM D3577 requirements
for tensile strength and elongation
at break before and after
accelerated aging | | | Freedom from holes | 21 CFR 800.20 and ASTM D3577,
tested according to ASTM D5151 | Exceeds 21 CFR 800.20 and
ASTM D3577 requirements of
AQL 1.5 | | | Powder residual | ASTM D3577 tested according to
ASTM D6124 | Meets powder level requirements
for "Powder-free" designation per
ASTM D3577 | | | | | | | | Clinical Data Summary - Subject Device (modified version of the predicate) | | | | | Clinical testing : | Clinical data is not required | | | #### Reason for 510(k) Submission: This premarket notification has been prepared to obtain clearance for a new surgeon's glove, the Biogel® PI Micro Indicator Underglove. The subject device is a new addition to our surgical glove product portfolio and is similar in design to the Bioge® Pl Indicator® Underglove, previously cleared under premarket notification K111413. #### Description of Device: The subject device is a single-use disposable powder-free surgical glove that is supplied sterile and made from synthetic polyisoprene material (not made from natural rubber latex). #### Intended Use/Indication for Use: The Biogel® PI Micro Indicator Underglove is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. {4}------------------------------------------------ ## Technological Characteristics: {5}------------------------------------------------ ## Conclusion: The subject devices are substantially equivalent to the Biogel® Pl Indicator® Underglove previously cleared under K111413 with respect to design, technological characteristics, intended use, and conformance to standard requirements. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K150146](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K150146) **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