(71 days)
Not Found
No
The device is a surgical glove, and the summary describes its material, physical characteristics, and performance testing related to biocompatibility and physical properties. There is no mention of AI or ML technology.
No
The device is a surgical glove intended as a barrier, not to treat or diagnose a disease or condition.
No
The device is described as a surgical glove intended to provide a barrier against contaminants, which is a protective function, not a diagnostic one.
No
The device is a physical surgical glove made of Poly-Isoprene material, with no mention of software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a barrier against potentially infectious material and other contaminants by being worn on the hands in a surgical setting. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a surgical glove, designed for physical protection.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical glove does not fit that description.
N/A
Intended Use / Indications for Use
The Biogel PI Micro Surgical Glove is a disposable device made of Poly-Isoprene material that is intended to be worn on the hands, usually in surgical setting, to provide a barrier against potentially infectious materials 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 Poly-Isoprene material (not made from natural rubber latex). The gloves are manufactured using hand-specific molds (right and left hand). Each glove contains a beaded cuff to help reduce cuff roll-down during use.
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 settings
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)
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):
Length: 284 - 310 mm, meet the ASTM minimum requirements of 245 mm for size 5½ and 265 mm for size 6 to 9.
Width: 71 -116 mm, meet the ASTM requirement of 70 - 114 ± 6 mm.
Thickness: ≥ 0.30mm, Exceeds the ASTM minimum requirement of 0.10 mm.
Physical Properties (ASTM D3577): Results meet requirements for rubber surgical gloves before and after accelerated ageing.
Before ageing:
Average Values Before ageing:
Tensile strength: 28 - 29 MPa
Stress at 500% elongation: 1.8 - 1.9 Mpa
Ultimate elongation: 1100 -1120 %
After accelerated ageing:
Average Values After accelerated ageing:
Tensile strength: 22- 24 MPa
Ultimate elongation: 1100 - 1140%
Freedom from holes (21 CFR 800.20 and ASTM D3577 tested according to ASTM D5151): Passed AQL 0.65, exceeds 21 CFR 800.20 and ASTM D3577 requirements of AQL 1.5.
Powder residual (ASTM D3577 tested using ASTM standard D6124): Glove meets powder level requirements for "Powder-free" designation per ASTM D3577 testing using ASTM standard D6124. Results generated values below 2 mg of residual powder per glove.
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 Surgical Glove (K050184)
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
§ 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/2 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 image of three faces in profile, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
September 4, 2014
Molnlycke Health Care, US, LLC Curtis D. Truesdale, RAC Director, Regulatory Affairs for the Americas 5550 Peachtree Parkway, Suite 500 Norcross, GA 30092
Re: K141719
Trade/Device Name: Biogel® PI Micro Surgical Glove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 4, 2014 Received: August 5, 2014
Dear Mr. Curtis D. Truesdale,
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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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); 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141719
Device Name
Biogel PI Micro Surgical Glove
Indications for Use (Describe)
The Biogel Pl Micro Surgical Glove is a disposable device made of Poly-Isoprene material that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other co otaminarts
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY FOR FOR
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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:
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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: | August 4, 2014 |
|---|---|
| Applicant: | Mölnlycke Health Care US, LLC |
| 5550 Peachtree Parkway, Suite 500 | |
| Norcross, GA 30092 | |
| Registration number: 3004763499 | |
| Owner/Operator Number: 8030877 | |
| Official Correspondent: | Curtis Truesdale |
| Director, Regulatory Affairs of the Americas | |
| Tel: 678-250-7928 | |
| Fax: 678-245-7746 | |
| email: curtis.truesdale@molnlycke.com | |
| Trade/Proprietary Names: | Biogel® PI Micro Surgical Glove |
| Regulation Name: | Surgeon's Glove |
| Device Class: | Class I |
| Regulation Number: | 21 CFR 878.4460 |
| Product Code: | KGO |
| Predicate Device Name(s): | Biogel® PI Surgical Glove (K050184) |
Reason for 510(k) Submission:
This 510(k) supports a design modification made to the Biogel® PI Surgical Glove (reference code 408) that was previously cleared through 510(k) K050184. The design modifications consist of a reduction in material thickness from 0.62 + 0.06 mm to 0.42 + 0.04 mm and the removal of the donning coating. In order to commercially distinguish the modified version from the original glove, the modified glove is branded under the trade name Biogel® PI Micro Surgical Glove, reference code 485, and the original glove remains branded under the trade name Biogel PI Surgical Glove, reference code 408.
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Description of Device:
The subiect device is a single-use disposable powder-free surgical glove that is supplied sterile and made from synthetic Poly-Isoprene material (not made from natural rubber latex). The gloves are manufactured using hand-specific molds (right and left hand). Each glove contains a beaded cuff to help reduce cuff roll-down during use.
Intended Use/Indication for Use:
The Biogel® PI Micro Surgical Glove is a disposable device made of Poly-Isoprene material that is intended to be worn on the hands, usually in surgical setting, to provide a barrier against potentially infectious materials and other contaminants.
Technological Characteristics:
Biogel® PI Micro Surgical Gloves were produced as a result of modifications made to the existing Biogel® PI Gloves that were previously cleared through 510(k) K050184. The gloves that were produced through these device modifications remain substantially equivalent in terms of technological characteristics, material formulation and intended use. The most notable technological differences between the subject and predicate Biogel® gloves are material thickness and donning coating. These technological characteristics and design modifications implemented for the subject device have been assessed and confirmed that the standard requirements that are appropriate for surgical gloves have been met. The following table is a summary of these technological characteristics in relation to standardized requirements.
| Feature | Biogel® PI Micro
Synthetic Polyisoprene Surgical
Glove | Biogel® Polyisoprene Non-latex
Sterile Powder-Free Surgeon's Glove
(Trade name reflected in 510k filing) |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device
(modified version of the predicate) | Predicate Device |
| 510(k) clearance | K141719 | K050184 |
| Manufacturer | Mölnlycke | Mölnlycke |
| Regulation number | 21CFR 878.4460 | 21CFR 878.4460 |
| Regulation name | Surgeon's Glove | Surgeon's Glove |
| Regulatory class | Class I | Class I |
| Product code | KGO | KGO |
| Intended use | Powder-Free Surgeon's Glove | Powder-Free Surgeon's Glove |
| Indication for use | Biogel® PI Micro Synthetic
Polyisoprene Surgical glove is
a disposable device made of
polyisoprene that is intended to
be worn on the hands, usually
in surgical setting, to provide a
barrier against potentially
infectious material and other
contaminants | Polyisoprene Non-Latex Sterile
Powder-Free Surgeon's Glove is a
disposable device made of
polyisoprene 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 sprayed with an
antislip polychloroprene band
below the bead. | Beaded cuff sprayed with an antislip
polychloroprene band below the
bead. |
| Thickness | $0.42 \pm 0.04$ mm | $0.62 \pm 0.06$ mm |
| Coating | No | Yes |
| Colour | Natural | Natural |
| 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 $\leq 2.0$
mg/glove for Powder-free
designation per ASTM D3577 | Meets requirements of $\leq 2.0$
mg/glove for Powder-free designation
per ASTM D3577 |
| Performance Test Data Summary - New Modified Device | | |
| Characteristics | 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 | Length: 284 - 310 mm, meet the
ASTM minimum requirements of 245
mm for size 5½ and 265 mm for size
6 to 9. |
| | | Width : 71 -116 mm, meet the ASTM
requirement of 70 - 114 ± 6 mm. |
| | | Thickness : ≥ 0.30mm, Exceeds the
ASTM minimum requirement of 0.10
mm. |
| Physical Properties | ASTM D3577 | Results meet requirements for rubber
surgical gloves before and after
accelerated ageing. |
| | Before ageing : | Average Values Before ageing : |
| | Tensile strength : 17 MPa min | Tensile strength : 28 - 29 MPa |
| | Stress at 500% elongation : 7.0
MPa max.
AQL 4.0 | Stress at 500% elongation : 1.8 - 1.9
Mpa |
| | Ultimate elongation : 650 %
min | Ultimate elongation : 1100 -1120 % |
| | | |
| | After accelerated ageing : | Average Values After accelerated
ageing : |
| | Tensile strength : 12 MPa min | Tensile strength : 22- 24 MPa |
| | Ultimate elongation : 490 %
min | Ultimate elongation : 1100 - 1140% |
| | | |
| Freedom from holes | 21 CFR 800.20 and ASTM
D3577 tested according to
ASTM D5151 | Passed AQL 0.65, exceeds 21 CFR
800.20 and ASTM D3577
requirements of AQL 1.5 |
| | | |
| Powder residual | ASTM D3577 tested using
ASTM standard D6124 | Glove meets powder level
requirements for "Powder-free"
designation per ASTM D3577 testing
using ASTM standard D6124.
Results generated values below 2 mg
of residual powder per glove. |
| Clinical testing : | | |
| Clinical data is not
required | | |
Summary of technological characteristics of the device compared to the predicate device
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Conclusion:
The subject devices are substantially equivalent to the Biogel® Surgical Gloves previously 510(k) cleared (K050184) with respect to design, technological characteristics, and intended use and conformance to standard requirements.