(272 days)
Not Found
No
The 510(k) summary describes a surgical glove with a coating and color designed to improve visibility of breaches. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies are nonclinical tests related to physical properties and standards, not algorithmic performance.
No.
Explanation: The device is a surgical glove intended to protect a surgical wound from contamination and promote visibility of a fluid that breaches the glove. It is a barrier device, not one that treats or diagnoses a medical condition.
No
The device is a surgical glove intended to protect a surgical wound from contamination and to promote visibility of a fluid that breaches/enters the glove by increasing its spreading rate. It does not diagnose any medical condition or disease.
No
The device is a physical surgical glove made of synthetic polyisoprene rubber, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination and to promote visibility of a fluid breach when used as an underglove. This is a protective barrier function and a visual aid, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical properties of the glove (material, color, coatings) and its function as a barrier and visual indicator. There is no mention of reagents, assays, or analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a surgical glove with features designed to enhance its protective and visual properties in a surgical setting. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Gammex PI Breach Detect Powder Free Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Gammex Pl Breach Detect Powder Free Surgical Glove is a sterile, green in color, single use disposable powder free surgical glove. The glove is made of synthetic polyisoprene rubber. A polymer is applied to the inner surface of the glove to make donning easy. The glove's outer surface is coated with a surface-active agent and when used as an under-glove, this coating and the glove's green color can improve visibility of a glove breach by promoting wetting of the glove surface and spreading of bodily fluid penetrating the breach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
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)
A clinical study was not conducted on the subject or predicate devices.
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.
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/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The word "Administration" is on the second line.
February 6, 2018
Ansell Healthcare Products LLC Don Cronk Sr Manager, QARA / Technical Services 111 Wood Avenue South, Suite 210 Iselin, New Jersey 08830
Re: K171375
Trade/Device Name: Gammex PI Breach Detect Powder Free Surgical Glove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: December 20, 2017 Received: December 27, 2017
Dear Don Cronk:
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.
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);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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) K171375
Device Name:
Gammex PI Breach Detect Powder Free Surgical Glove
Indications for Use (Describe)
Gammex PI Breach Detect Powder Free Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
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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3
510k Summary
510(k): K171375
Submitter
Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 USA
Contact Person:
Donald J. Cronk Senior Manager QA/RA/Technical Services Phone: (775) 470-7106 Email: don.cronk@ansell.com
Date Prepared
January 22, 2018
Name of Device
| Trade Names: | Gammex PI Breach Detect Powder Free Surgical Glove | |
|---|---|---|
| Common Name: | Surgeon's Gloves | |
| Classification Name: | Surgeon's Gloves | |
| Classification Regulation: | 21 CFR 878.4460 | |
| Device Class: | I | |
| Product Code: | KGO | |
| Classification Panel: | General and Plastic Surgery |
Legally Marketed Predicate Device
K071746 – DermaPrene® Pl or IsoTouch Green Sterile Powder-Free Polyisoprene Surgical Gloves Surgeon's Gloves Common Name: Classification Name: Surgeon's Gloves Classification Regulation: 21 CFR 878.4460 Device Class: -Product Code: KGO Classification Panel: General and Plastic Surgery
Device Description
Gammex Pl Breach Detect Powder Free Surgical Glove is a sterile, green in color, single use disposable powder free surgical glove. The glove is made of synthetic polyisoprene rubber. A polymer is applied to the inner surface of the glove to make donning easy. The glove's outer surface is coated with a surface-active agent and when used as an under-glove, this coating and the glove's green color can improve visibility of a glove breach by promoting wetting of the glove surface and spreading of bodily fluid penetrating the breach.
Indication for Use Statement
Gammex PI Breach Detect Powder Free Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
4
Technological Characteristics
Gammex Pl Breach Detect Powder Free Surgical Gloves have the following technological characteristics as compared to ASTM or equivalent standards:
| Characteristics | Standard/Test/FDA Guidance | Result Summary |
|---|---|---|
| Physical Characteristics: | ||
| Dimensions | ASTM D3577-09 | Meets ASTM D3577-09 requirements for length, width and thickness |
| Length | Minimum 265mm | Average value: |
| Minimum 297 mm | ||
| Palm Width (mm) | Average value in mm: | |
| Size 5.5 | $70 \pm 6$ | 76 |
| Size 6.0 | $76 \pm 6$ | 82 |
| Size 6.5 | $83 \pm 6$ | 86 |
| Size 7.0 | $89 \pm 6$ | 91 |
| Size 7.5 | $95 \pm 6$ | 98 |
| Size 8.0 | $102 \pm 6$ | 100 |
| Size 8.5 | $108 \pm 6$ | 112 |
| Size 9.0 | $114 \pm 6$ | 120 |
| Thickness (mm) – single wall | Average value in mm | |
| Finger | Minimum 0.10 | 0.25 |
| Palm | Minimum 0.10 | 0.21 |
| Cuff | Minimum 0.10 | 0.17 |
| Physical Properties: | ASTM D3577-09 | Meets ASTM D3577-09 requirements |
| for tensile strength, ultimate | ||
| elongation and stress at 500% | ||
| elongation before and after | ||
| accelerated aging for synthetic | ||
| surgical gloves | ||
| Freedom from holes | ASTM D3577-09 | |
| ASTM D5151-06 | Meets ASTM D3577-09 and ASTM | |
| D5151-06 requirements of AQL 1.5 | ||
| Powder Residual | ASTM D3577-09 | |
| ASTM D6124-06 | Meets applicable requirement for | |
| powder free; ≤ 2 mg per glove | ||
| Sterility | ANSI/AAMI/ISO 11137-1:2006 | Meets ANSI/AAMI/ISO 11137-1:2006 |
| requirement of $10^{-6}$ SAL. | ||
| Biocompatibility | ||
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009 | Under the conditions of the study, |
| undiluted and 1:2 dilution were | ||
| cytotoxic. 1:4, 1:8, 1:16, 1:32 and 1:64 | ||
| are not cytotoxic | ||
| ISO Skin Irritation Study | ISO10993-10:2010 | Under the conditions of the study, |
| not an irritant | ||
| ISO Maximization | ||
| Sensitization Study | ISO 10993-10:2010 | Under the conditions of the study, |
| not a sensitizer | ||
| ISO acute systemic | ||
| toxicity | ISO 10993-11: 2006 | Under the conditions of the study, no |
| evidence of systemic toxicity |
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Substantial Equivalence
| | Predicate Device | Subject Device | Substantial
Equivalence |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Trade Name | DermaPrene® PI or IsoTouch
Green Sterile Powder-Free
Polyisoprene Surgical Gloves | Gammex® PI Breach Detect
Powder Free Surgical Glove | Not applicable |
| 510(k) Number | K071746 | K171375 | Not applicable |
| Submitter | Ansell Healthcare Products LLC | Ansell Healthcare Products LLC | Same |
| Product Code | KGO | KGO | Same |
| Regulation
Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Regulation
Name | Surgeon's Glove | Surgeon's Glove | Same |
| Regulatory Class | Class I | Class I | Same |
| Device Type | Type 2
Gloves compounded primarily
from rubber cement or synthetic
rubber latex | Type 2
Gloves compounded primarily
from rubber cement or
synthetic rubber latex | Same |
| Indications for
use | These gloves are intended to be
worn by operating room
personnel to protect a surgical
wound from contamination | These gloves are intended to
be worn by operating room
personnel to protect a surgical
wound from contamination.
When used as an underglove,
the glove is intended to
promote visibility of a fluid that
breaches/enters the glove via
an increased spreading rate. | Different |
| Prescription or
Over-The
Counter-Use | Over-The-Counter-Use | Over-The-Counter-Use | Same |
| Material | Synthetic Polyisoprene Rubber | Synthetic Polyisoprene Rubber | Same |
| Coating (inner) | Polyurethane polymer inner
coating to aid donning | Polyurethane polymer inner
coating to aid donning | Same |
| Coating (outer) | None | Proprietary solution to aid in
wetting/spreading of fluid
when used as an underglove | Different |
| | | and the outer surgeon's glove
is breached. | |
| Design | Single use | Single use | Same |
| | Sterile | Sterile | Same |
| | Powder-Free | Powder-Free | Same |
| | Hand-specific | Hand-specific | Same |
| | Beaded cuff | Beaded cuff | Same |
| Color | Green | Green | Same |
| Dimension &
physical
properties | Meets ASTM D3577-09
requirements | Meets ASTM D3577-09
requirements | Same |
| Freedom from
holes | Meets ASTM D3577-09
requirements of AQL 1.5 | Meets ASTM D3577-09
requirements of AQL 1.5 | Same |
| Powder-Free | Meets applicable definition for
powder free; ≤ 2mg per glove | Meets applicable definition for
powder free; ≤ 2mg per glove | Same |
| Sterilization
method | Radiation | Radiation | Same |
| Sterility
Assurance Level
(SAL) | 10-6 SAL | 10-6 SAL | Same |
| Shelf life | 3 years | 3 years | Same |
| Biocompatibility | "Under the conditions of the
study, not an irritant" and
"Under the conditions of the
study, not a sensitizer" | "Under the conditions of the
study, not an irritant" and
"Under the conditions of the
study, not a sensitizer" | Same |
Substantial Equivalence Comparison Table
6
The subject device is manufactured from polyisoprene with polyurethane polymer inner coating to aid donning. The glove's outer surface is coated with a surface-active agent and when used as an under-glove, this coating and the glove's green color can improve visibility of a glove breach by promoting wetting of the glove surface and spreading of bodily fluid penetrating the breach. Aside from the outer surface treatment, the subject device's materials are functionally equivalent to those of the cited predicate.
The subject device meets the applicable requirements for surgeon's gloves regarding dimensions and sizes, physical properties, freedom from holes, and powder residues as found in the following standards: ASTM D3577, ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization and irritation, in accord with the ISO 10993 series of standards.
Performance Data
A clinical study was not conducted on the subject or predicate devices.
Substantial Equivalence Statement
7
The Gammex PI Breach Detect Powder Free Surgeon's Glove are as safe and effective as the predicate device with respect to design, technological characteristics, intended use and conformance to standard requirements.
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed device, K071746