(128 days)
No
The device is a surgical glove and the description focuses on its material, intended use as a barrier, and physical properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a surgical glove intended to provide a barrier against contaminants, not to treat or cure a disease or condition.
No
Explanation: The device is described as a surgical glove intended to provide a barrier against infectious material and contaminants, not to diagnose a medical condition.
No
The device is a physical surgical glove made of polyisoprene, not a software application. The description focuses on material properties and physical performance testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a barrier worn on the hands to protect against infectious material and contaminants. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description confirms they are surgical gloves for physical protection.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on physical characteristics (dimensions, strength, freedom from holes, powder) and biocompatibility (skin irritation, sensitization, toxicity), which are relevant for a barrier device, not a diagnostic one.
- Predicate Devices: The predicate devices are also surgical gloves, further reinforcing the device's classification as a physical barrier.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Bioge® PI UltraTouch S Surgical Glove is a disposable device made of polyisoprene, 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.
The Bioge® PI UltraTouch S 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
KGO
Device Description
Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene, and a single-use, sterile, blue underglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene. The overglove, and underglove may be used independently or worn as a double-gloving pair if desired.
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
Surgical setting / Surgeon
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)
Summary of Non-Clinical Testing:
Biocompatibility:
Primary Skin Irritation: Under the conditions of the study, not an irritant.
ISO Closed Patch Sensitization: Under the conditions of the study, not a sensitizer.
Acute Systemic Toxicity Study: Under the conditions of the study, no mortality or evidence of systemic toxicity from the extracts.
Physical characteristics:
Dimensions: Meets ASTM D3577-09(2015) requirements for length, width, and thickness. Identical to predicate.
Physical Properties: Meets ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging. Identical to Predicate.
Freedom from holes: Exceeds 21 CFR 800.20 and ASTM D3577-09(2015) requirements of AQL 1.5. Identical to predicate.
Powder residual: Meets powder level requirements for "Powder-free" designation per ASTM D3577-09(2015). Identical to predicate.
Clinical Data Summary - Subject Device (modified version of the predicate)
Clinical testing: Clinical data is not required. Identical to predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
My 24, 2019
Molnlycke Health Care, US LLC Leonard Stewart Regulatory Affairs Specialist 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092
Re: K190077
Trade/Device Name: Biogel® PI UltraTouch S Surgical Glove, Biogel® PI Ultra Touch S Indicator Underglove Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: February 28, 2019 Received: March 1, 2019
Dear Leonard Stewart:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For David Krause, PhD Acting Director Division of Infection Control and Plastic Surgery Office of Surgical & Infection Control Devices Office of Product Evaluation & Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Biogel® PI UltraTouch S Surgical Glove and Biogel® PI UltraTouch S Indicator Underglove
Indications for Use (Describe)
The Bioge® PI UltraTouch S Surgical Glove is a disposable device made of polyisoprene, 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.
The Bioge® PI UltraTouch S 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.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY (K190077)
for
Biogel® PI UltraTouch S Surgical Glove and Biogel®Pl UltraTouch S Indicator Underglove
| Date Prepared: | May 22, 2019 |
|---|---|
| Submission Sponsor: | Mölnlycke Health Care US, LLC |
| 5550 Peachtree Parkway, Suite 500 | |
| Norcross, GA 30092 | |
| Registration number: 3004763499 | |
| Owner/Operator Number: 8030877 | |
| Submission Correspondent: | Leonard Stewart |
| Regulatory Affairs Specialist | |
| Tel: 470-375-0178 | |
| Fax: 678-245-7746 | |
| email: leonard.stewart@molnlycke.com | |
| Trade/Proprietary Names: | Biogel® PI UltraTouch S Surgical Glove and Biogel®PI |
| UltraTouch S Indicator Underglove | |
| Regulation Name: | Non-powered surgeon's glove |
| Common Name: | Surgeon's Glove |
| Classification Name: | Surgeon's Glove |
| Device Class: | Class I |
| Regulation Number: | 21 CFR 878.4460 |
| Product Code: | KGO |
| 510(k) Submission Number: | K190077 |
| Predicate Device Name(s): | Biogel® PI UltraTouch Surgical Glove (SKINSENSE®POLY- |
| ISOPRENE POWDER-FREE NON-LATEX GLOVE, K050184), | |
| Biogel® Indicator Underglove (BIOGEL® INDICATOR ® | |
| UNDERGLOVE, K111413) |
Description of Device:
Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene, and a single-use, sterile, blue underglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene. The overglove, and underglove may be used independently or worn as a double-gloving pair if desired.
Indications for Use:
The Biogel® PI UltraTouch S Surgical Glove is a disposable device made of polvisoprene, 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
The Biogel® PI UltraTouch S 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
| | Summary of technological characteristics of the subject device
compared to the predicate device | | | | | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | (overglove) | | | (underglove) | | |
| | Biogel® PI
UltraTouch S
Surgical
Glove
(Subject
Device) | Biogel® PI
UltraTouch
Surgical
Glove
(Predicate
Device) | Comment | Biogel® PI
UltraTouch S
Indicator
Underglove
(Subject
Device) | Biogel® PI
Indicator
Underglove
(Predicate
Device) | Comment |
| 510(k)
Number | K190077 | K050184 | - | K190077 | K111413 | - |
| Manufacturer | Mölnlycke | Mölnlycke | Identical | Mölnlycke | Mölnlycke | Identical |
| Regulation
number | 21CFR
878.4460 | 21CFR
878.4460 | Identical | 21CFR
878.4460 | 21CFR
878.4460 | Identical |
| Regulation
name | Surgeon's
Glove | Surgeon's
Glove | Identical | Surgeon's
Glove | Surgeon's
Glove | Identical |
| Regulatory
class | Class 1 | Class 1 | Identical | Class 1 | Class 1 | Identical |
| Product code | KGO | KGO | Identical | KGO | KGO | Identical |
| Intended use | Powder-Free
Surgeon's
Glove | Powder-Free
Surgeon's
Glove | Identical | Powder-Free
Surgeon's
Glove | Powder-Free
Surgeon's
Glove | Identical |
| Indication for
use | Biogel® PI
UltraTouch S
Surgical Glove
(Overglove) is
a disposable
device made
of
polyisoprene,
that is
intended to be
worn on the
hands, usually
in surgical
settings, to
provide a | Biogel® PI
UltraTouch
Surgical
glove(Overgl
ove) A
powder-free
sterile
surgeon's
glove is a
disposable
device made
of
polyisoprene
that is
intended to
be worn on | Similar | Biogel® PI
UltraTouch S
Indicator
Underglove is a
disposable
device made of
polyisoprene,
blue in color
that is intended
to be worn on
the hands,
usually in
surgical
settings, to
provide a | 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 a
surgical
setting, to
provide a | Similar |
| | Summary of technological characteristics of the subject device
compared to the predicate device | | | | | |
| | potentially
infectious
material and
other
contaminants | the hands,
usually in
surgical
settings; to
provide a
barrier
against
potentially
infectious
materials and
other
contaminants | | potentially
infectious
material and
other
contaminants | barrier
against
potentially
infectious
material and
other
contaminants | |
| Material | Synthetic
Polyisoprene | Synthetic
Polyisoprene | Identical | Synthetic
Polyisoprene | Synthetic
Polyisoprene | Identical |
| Design | Single use | Single use | Identical | Single use | Single use | Identical |
| | Sterile | Sterile | Identical | Sterile | Sterile | Identical |
| | Powder-free | Powder-free | Identical | Powder-free | Powder-free | Identical |
| | Hand specific | Hand specific | Identical | Hand specific | Hand specific | Identical |
| | Beaded Cuff | Beaded cuff | Identical | Beaded cuff | Beaded cuff | Identical |
| Coating | Yes | Yes | Identical | Yes | Yes | Identical |
| Color | Straw
(Natural) | Straw
(Natural) | Identical | Blue | Blue | Identical |
| Sterilization
method | Radiation | Radiation | Identical | Radiation | Radiation | Identical |
| Sterility
Assurance
Level (SAL) | 10-6 SAL | 10-6 SAL | Identical | 10-6 SAL | 10-6 SAL | Identical |
| Dimensions
& physical
properties | Meets ASTM
D3577-
09(2015) | Meets ASTM
D3577-
09(2015) | Identical | Meets ASTM
D3577-
09(2015) | Meets ASTM
D3577-
09(2015) | Identical |
| Freedom
from holes | AQL meets 21
CFR 800.20
and ASTM
D3577-
09(2015)
requirements | AQL meets
21 CFR
800.20 and
ASTM
D3577-
09(2015)
requirements | Identical | AQL meets 21
CFR 800.20
and ASTM
D3577-
09(2015)
requirements | AQL meets
21 CFR
800.20 and
ASTM
D3577-
09(2015)
requirements | Identical |
| Powder
residual | Meets
requirements
of ≤ 2.0
mg/glove for
Powder-free
designation
per ASTM
D3577-
09(2015) | Meets
requirements
of ≤ 2.0
mg/glove for
Powder-free
designation
per ASTM
D3577-
09(2015) | Identical | Meets
requirements of
≤ 2.0 mg/glove
for Powder-free
designation per
ASTM D3577-
09(2015) | Meets
requirements
of ≤ 2.0
mg/glove for
Powder-free
designation
per ASTM
D3577-
09(2015) | Identical |
Technological Characteristics:
5
6
Summary of Non-Clinical Testing:
| Summary of Non-Clinical Testing | |||
|---|---|---|---|
| Standard/Test/FDA Guidance | Biogel® PI | ||
| UltraTouch S | |||
| Surgical Glove | |||
| (Subject Device) | Biogel® PI | ||
| UltraTouch S | |||
| Indicator | |||
| Underglove | |||
| (Subject Device) | |||
| Biocompatibility: | |||
| Primary Skin | |||
| Irritation | ISO 10993-10:2010 Biological | ||
| evaluation of medical devices — | |||
| Part 10: Tests for irritation and skin | |||
| sensitization | Under the conditions of the study, not an | ||
| irritant. | |||
| ISO Closed | |||
| Patch | |||
| Sensitization | ISO 10993-10:2010 Biological | ||
| evaluation of medical devices — | |||
| Part 10: Tests for irritation and skin | |||
| sensitization | Under the conditions of the study, not a | ||
| sensitizer. | |||
| Acute Systemic | |||
| Toxicity Study | ISO 10993-11:2010 Biological | ||
| evaluation of medical devices — | |||
| Part 11: Tests for systemic toxicity | Under the conditions of the study, no | ||
| mortality or evidence of systemic toxicity | |||
| from the extracts. | |||
| Physical | |||
| characteristics: | |||
| Dimensions | ASTM D3577- 09(2015) | ||
| Standard Specification for | |||
| Rubber Surgical Gloves | Meets ASTM D3577-09(2015) requirements | ||
| for length, width, and thickness. Identical to | |||
| predicate. | |||
| Physical | |||
| Properties | ASTM D3577- 09(2015) | ||
| Standard Specification for | |||
| Rubber Surgical Gloves | Meets ASTM D3577-09(2015) | ||
| requirements for tensile strength and | |||
| elongation at break before and after | |||
| accelerated aging. Identical to Predicate. | |||
| Freedom from | |||
| holes | ASTM D5151-06(2015) Standard | ||
| Test Method for Detection of Holes | |||
| in Medical Gloves | |||
| ASTM D3577- 09(2015) Standard | |||
| Specification for Rubber Surgical | |||
| Gloves | Exceeds 21 CFR 800.20 and ASTM | ||
| D3577-09(2015) requirements of AQL | |||
| 1.5. Identical to predicate. | |||
| Powder residual | ASTM D6124-06(2017) Standard | ||
| Test Method for Residual Powder | |||
| on Medical Gloves | |||
| ASTM D3577- 09(2015) Standard | |||
| Specification for Rubber Surgical | |||
| Gloves | Meets powder level requirements for | ||
| "Powder-free" designation per ASTM | |||
| D3577-09(2015). Identical to predicate. | |||
| Clinical Data Summary - Subject Device (modified version of the predicate) | |||
| Clinical testing | Clinical data is not required. Identical to predicate. |
Conclusion:
Based on the Indication for Use, technological characteristics, and non-clinical performance data, Bioge®® Pl UltraTouch S Surgical Glogel® Pl UltraTouch S Indicator Underglove (K190077) are as safe, as effective, and perform as well as or better than the legally marketed predicate devices Bioge®® PI UltraTouch Surgical Glove (K050184) and the Bioge®® PI Indicator Underglove (K111413).