Biogel PI Micro Indicator Underglove

• K Number: K150146
• Device Name: Biogel PI Micro Indicator Underglove
• Manufacturer: MOLNLYCKE HEALTH CARE US, LLC
• Date Cleared: 2015-08-31 ( 221 days)
• Product Code: KGO
• Regulation Number: 878.4460

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 Description

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).

Predicate Devices

K111413

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a surgical glove and its physical and biocompatibility testing, with no mention of AI or ML.

Therapeutic

No.
The device is a surgical glove intended to provide a barrier against contaminants, not to treat or cure a disease or condition.

Diagnostic

No

This device is a surgical glove intended to provide a barrier against infectious material, not diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a disposable surgical glove made of polyisoprene, which is a physical hardware component, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is clearly stated as providing a barrier against potentially infectious material and other contaminants when worn on the hands, usually in a surgical setting. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
• Device Description: The device is described as a surgical glove, which is a barrier device.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing a sample (blood, urine, tissue, etc.)
  • Detecting or measuring a substance in a sample
  • Providing information for diagnosis, monitoring, or screening of a disease or condition
  • Using reagents or other diagnostic components

The information provided describes a medical device used for protection and barrier purposes, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

KGO

Device Description

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Test Data Summary - Subject Device (modified version of the predicate)
Standard/Test/FDA Guidance: Biocompatibility : Primary Skin Irritation ISO 10993-10
Results Summary: Under the conditions of the study, not an irritant.

Standard/Test/FDA Guidance: Biocompatibility : ISO Closed Patch Sensitization ISO 10993-10
Results Summary: Under the conditions of the study, not a sensitizer.

Standard/Test/FDA Guidance: Physical characteristics : Dimensions ASTM D3577
Results Summary: Meets ASTM D3577 requirements for length, width, and thickness

Standard/Test/FDA Guidance: Physical characteristics : Physical Properties ASTM D3577
Results Summary: Meets ASTM D3577 requirements for tensile strength and elongation at break before and after accelerated aging

Standard/Test/FDA Guidance: Physical characteristics : Freedom from holes 21 CFR 800.20 and ASTM D3577, tested according to ASTM D5151
Results Summary: Exceeds 21 CFR 800.20 and ASTM D3577 requirements of AQL 1.5

Standard/Test/FDA Guidance: Physical characteristics : Powder residual ASTM D3577 tested according to ASTM D6124
Results Summary: 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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Biogel® PI Indicator® Underglove (K111413)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
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.(b)
Classification. Class I (general controls).

Summary

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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)

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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: [phone]
Fax: [phone]
email: [e-mail]
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.

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Technological Characteristics:

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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.