(272 days)
Gammex PI Breach Detect Powder Free Surgical 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.
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.
This document describes a 510(k) premarket notification for a medical device called "Gammex PI Breach Detect Powder Free Surgical Glove" (K171375). However, the document does not contain the kind of detailed information about acceptance criteria and performance study results that would typically be found for an AI/ML-driven medical device, such as a diagnostic algorithm.
The device in question is a surgical glove, which is a Class I device. The FDA's review for Class I devices generally focuses on demonstrating substantial equivalence to a predicate device based on defined physical, material, and biocompatibility characteristics, rather than extensive clinical performance studies or AI model validation.
Therefore, many of the specific questions you've asked (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, ground truth for training sets) are not applicable to this device and the information provided in this 510(k) summary.
Here's a breakdown based on the provided text, addressing what is available and explaining why other aspects are absent:
1. A table of acceptance criteria and the reported device performance
The document provides a table outlining "Technological Characteristics" compared to ASTM or equivalent standards. These function as the acceptance criteria for a surgical glove.
| Characteristics | Standard/Test/FDA Guidance | Acceptance Criteria (Implied by Standard) | Reported Device Performance (Result Summary) |
|---|---|---|---|
| Physical Characteristics: | |||
| Dimensions: Length | ASTM D3577-09 | Minimum 265mm | Average value: Minimum 297 mm (Meets) |
| Dimensions: Palm Width (mm) | ASTM D3577-09 | Size 5.5: $70 \pm 6$ Size 6.0: $76 \pm 6$ Size 6.5: $83 \pm 6$ Size 7.0: $89 \pm 6$ Size 7.5: $95 \pm 6$ Size 8.0: $102 \pm 6$ Size 8.5: $108 \pm 6$ Size 9.0: $114 \pm 6$ | Size 5.5: 76 Size 6.0: 82 Size 6.5: 86 Size 7.0: 91 Size 7.5: 98 Size 8.0: 100 Size 8.5: 112 Size 9.0: 120 (Meets) |
| Dimensions: Thickness (mm) – single wall (Finger, Palm, Cuff) | ASTM D3577-09 | Minimum 0.10 for Finger, Palm, Cuff | Finger: 0.25 Palm: 0.21 Cuff: 0.17 (Meets) |
| Physical Properties: | ASTM D3577-09 | Requirements for tensile strength, ultimate elongation, and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves. | Meets ASTM D3577-09 requirements (Meets) |
| Freedom from holes | ASTM D3577-09, ASTM D5151-06 | AQL 1.5 | Meets ASTM D3577-09 and ASTM D5151-06 requirements of AQL 1.5 (Meets) |
| Powder Residual | ASTM D3577-09, ASTM D6124-06 | ≤ 2 mg per glove | Meets applicable requirement for powder free; ≤ 2 mg per glove (Meets) |
| Sterility | ANSI/AAMI/ISO 11137-1:2006 | $10^{-6}$ SAL (Sterility Assurance Level) | Meets ANSI/AAMI/ISO 11137-1:2006 requirement of $10^{-6}$ SAL. (Meets) |
| Biocompatibility: | |||
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009 | Undiluted and 1:2 dilution not cytotoxic. | 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. (Note: This result is reported rather than a pass/fail against typical acceptance of "not cytotoxic at all concentrations". However, the overall conclusion for substantial equivalence indicates this was acceptable.) |
| ISO Skin Irritation Study | ISO10993-10:2010 | Not an irritant | Under the conditions of the study, not an irritant (Meets) |
| ISO Maximization Sensitization Study | ISO 10993-10:2010 | Not a sensitizer | Under the conditions of the study, not a sensitizer (Meets) |
| ISO acute systemic toxicity | ISO 10993-11: 2006 | No evidence of systemic toxicity | Under the conditions of the study, no evidence of systemic toxicity (Meets) |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML algorithm. The performance data refers to standard compliance tests (e.g., ASTM standards for glove characteristics). These tests involve sampling plans as defined within the respective standards, but the specific number of gloves tested for each characteristic is not provided in this summary.
- Data Provenance: Not applicable. These are laboratory test results based on manufactured glove samples. The data is not patient-derived from specific countries or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical product (surgical glove), not an AI/ML diagnostic device requiring expert interpretation of medical images or data for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-assisted diagnostic device. The document explicitly states: "A clinical study was not conducted on the subject or predicate devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground truth for this device is based on established engineering standards and material science properties (e.g., ASTM standards for dimensions, tensile strength, freedom from holes, powder residue; ISO standards for biocompatibility and sterility). The "truth" is whether the glove meets the specified physical and biological performance characteristics.
8. The sample size for the training set:
- Not Applicable. There is no AI/ML model for which to define a training set.
9. How the ground truth for the training set was established:
- Not Applicable.
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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);
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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
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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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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.
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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 requirementsfor tensile strength, ultimateelongation and stress at 500%elongation before and afteraccelerated aging for syntheticsurgical gloves |
| Freedom from holes | ASTM D3577-09ASTM D5151-06 | Meets ASTM D3577-09 and ASTMD5151-06 requirements of AQL 1.5 |
| Powder Residual | ASTM D3577-09ASTM D6124-06 | Meets applicable requirement forpowder free; ≤ 2 mg per glove |
| Sterility | ANSI/AAMI/ISO 11137-1:2006 | Meets ANSI/AAMI/ISO 11137-1:2006requirement of $10^{-6}$ SAL. |
| Biocompatibility | ||
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009 | Under the conditions of the study,undiluted and 1:2 dilution werecytotoxic. 1:4, 1:8, 1:16, 1:32 and 1:64are not cytotoxic |
| ISO Skin Irritation Study | ISO10993-10:2010 | Under the conditions of the study,not an irritant |
| ISO MaximizationSensitization Study | ISO 10993-10:2010 | Under the conditions of the study,not a sensitizer |
| ISO acute systemictoxicity | ISO 10993-11: 2006 | Under the conditions of the study, noevidence of systemic toxicity |
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Substantial Equivalence
| Predicate Device | Subject Device | SubstantialEquivalence | |
|---|---|---|---|
| Trade Name | DermaPrene® PI or IsoTouchGreen Sterile Powder-FreePolyisoprene Surgical Gloves | Gammex® PI Breach DetectPowder 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 |
| RegulationNumber | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| RegulationName | Surgeon's Glove | Surgeon's Glove | Same |
| Regulatory Class | Class I | Class I | Same |
| Device Type | Type 2Gloves compounded primarilyfrom rubber cement or syntheticrubber latex | Type 2Gloves compounded primarilyfrom rubber cement orsynthetic rubber latex | Same |
| Indications foruse | These gloves are intended to beworn by operating roompersonnel to protect a surgicalwound from contamination | These gloves are intended tobe worn by operating roompersonnel to protect a surgicalwound from contamination.When used as an underglove,the glove is intended topromote visibility of a fluid thatbreaches/enters the glove viaan increased spreading rate. | Different |
| Prescription orOver-TheCounter-Use | Over-The-Counter-Use | Over-The-Counter-Use | Same |
| Material | Synthetic Polyisoprene Rubber | Synthetic Polyisoprene Rubber | Same |
| Coating (inner) | Polyurethane polymer innercoating to aid donning | Polyurethane polymer innercoating to aid donning | Same |
| Coating (outer) | None | Proprietary solution to aid inwetting/spreading of fluidwhen used as an underglove | Different |
| and the outer surgeon's gloveis 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 &physicalproperties | Meets ASTM D3577-09requirements | Meets ASTM D3577-09requirements | Same |
| Freedom fromholes | Meets ASTM D3577-09requirements of AQL 1.5 | Meets ASTM D3577-09requirements of AQL 1.5 | Same |
| Powder-Free | Meets applicable definition forpowder free; ≤ 2mg per glove | Meets applicable definition forpowder free; ≤ 2mg per glove | Same |
| Sterilizationmethod | Radiation | Radiation | Same |
| SterilityAssurance Level(SAL) | 10-6 SAL | 10-6 SAL | Same |
| Shelf life | 3 years | 3 years | Same |
| Biocompatibility | "Under the conditions of thestudy, not an irritant" and"Under the conditions of thestudy, not a sensitizer" | "Under the conditions of thestudy, not an irritant" and"Under the conditions of thestudy, not a sensitizer" | Same |
Substantial Equivalence Comparison Table
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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
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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
§ 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).