(150 days)
Gammex PI Hybrid Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Gammex Pl Hybrid Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic rubber blend of polyisoprene and polychoroprene. A polyurethane polymer coating is applied to the inner surface of the glove to make donning eay. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and effective for handling chemotherapy agents.
The provided text describes the acceptance criteria and performance of the Gammex PI Hybrid Surgical Gloves, specifically regarding their resistance to chemotherapy drug permeation.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for chemotherapy drug permeation are implicitly defined by the reported "Minimum Breakthrough Detection Time" for each drug when tested according to ASTM D6978-05. A longer breakthrough time indicates better performance. For most drugs, the performance (>240 minutes) suggests that the gloves resist permeation for at least 4 hours, which is likely the desired acceptance criterion for practical use. The specific acceptance criteria for most physical/biological aspects are meeting the referenced ASTM and ISO standards.
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance (Gammex PI Hybrid Surgical Gloves) |
|---|---|
| Chemotherapy Permeation (ASTM D6978-05) | |
| Bleomycin sulfate (15.0 mg/ml) | >240 minutes |
| Busulfan (6.0 mg/ml) | >240 minutes |
| Carboplatin (10.0 mg/ml) | >240 minutes |
| Carmustine (3.3 mg/ml) | 23.6 minutes (Individual samples: 23.8, 26.5, 23.6) |
| Cisplatin (1.0 mg/ml) | >240 minutes |
| Cyclophosphamide (20.0 mg/ml) | >240 minutes |
| Cytarabine (100.0 mg/ml) | >240 minutes |
| Dacarbazine (10 mg/ml) | >240 minutes |
| Daunorubicin (5.0 mg/ml) | >240 minutes |
| Docetaxel (10.0 mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes |
| Epirubicin (2.0 mg/ml) | >240 minutes |
| Etoposide (20.0 mg/ml) | >240 minutes |
| Fludarabine (25.0 mg/ml) | >240 minutes |
| Fluorouracil (50.0 mg/ml) | >240 minutes |
| Gemcitabine (Gemzar) (38.0 mg/ml) | >240 minutes |
| Idarubicin (1.0 mg/ml) | >240 minutes |
| Ifosfamide (50.0 mg/ml) | >240 minutes |
| Irinotecan (20.0 mg/ml) | >240 minutes |
| Mechlorethamine HCl (1.0 mg/ml) | >240 minutes |
| Melphalan (5.0 mg/ml) | >240 minutes |
| Methotrexate (25.0 mg/ml) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | >240 minutes |
| Oxaliplatin (2.0 mg/ml) | >240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 minutes |
| Rituximab (10.0 mg/ml) | >240 minutes |
| ThioTEPA (10.0 mg/ml) | 36.1 minutes (Individual samples: 36.1, 37.0, 36.7) |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes |
| Dimensions (ASTM D3577-09) | Meets ASTM D3577-09 requirements for length, width, and thickness. |
| Length: Minimum 265mm | Average 303mm |
| Palm Width (e.g., size 7: 89±6mm) | Average values provided for sizes 5.5 to 9 (e.g., size 7: 91mm). |
| Finger Thickness: Minimum 0.10mm | 0.22mm |
| Palm Thickness: Minimum 0.10mm | 0.2mm |
| Cuff Thickness: Minimum 0.10mm | 0.15mm |
| Physical Properties (ASTM D3577-09) | Meets ASTM D3577-09 requirements for tensile strength and elongation at break before and after accelerated aging. |
| Freedom from holes (ASTM D3577-09 & ASTM D5151-06) | Meets AQL 1.5 requirements. |
| ASTM D3577-09 Inspection level/AQL: GI/AQL 0.65; Lot Size: 35,001 to 150,000 pieces; Sample size: 100 pieces; Accept number: 0 | Actual found: 0 |
| Powder-Free (ASTM D3577-09 & ASTM D6124-06) | Meets applicable requirement for Powder Free; ≤ 2 mg per glove. Averaged residual powder content for the glove during process validation is 0.48mg per glove. |
| Sterility (ANSI/AAMI/ISO 11137-1:2006) | Meets requirement of 10-6 SAL. |
| Biocompatibility: | |
| ISO in vitro cytotoxicity (ISO 10993-5:2009) | Device extract was found to be cytotoxic. (However, ISO 10993-11 systemic toxicity test showed no systemic response in the animal model, which is typically the follow-up for cytotoxic findings). |
| ISO Skin Irritation Study (ISO 10993-10:2010) | Not an irritant. |
| ISO Maximization Sensitization Study (ISO 10993-10:2010) | Not a sensitizer. |
| ISO Systemic Toxicity Study (ISO 10993-11:2006) | No mortality or evidence of systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
- Chemotherapy Permeation: For the permation testing, the table in section {5} (and {2}) indicates that the "Minimum Breakthrough Detection Time" is based on 3 samples (Sample 1, 2, 3), specifically shown for Carmustine and ThioTEPA. For other drugs, only the aggregate ">240" is given, implying consistent results across samples.
- Freedom from holes: For the specific ASTM D3577-09 test mentioned in section {6}, the sample size for this attribute was 100 pieces for a lot size of 35,001 to 150,000 pieces.
- Powder-Free: The average residual powder content (0.48mg per glove) was determined "during process validation," but the specific sample size for this validation is not detailed.
- Other tests (Dimensions, Physical Properties, Biocompatibility, Sterility): The sample sizes for these tests are not explicitly stated in the provided documents, but they would have been conducted according to the requirements of the respective ASTM/ISO standards.
- Data Provenance: The studies were conducted by Ansell Healthcare Products LLC, presumably at an independent laboratory, to support a labeling modification. The data is retrospective in the sense that it was performed on an already cleared device (K151694) to add a new claim (chemotherapy drug handling), rather than being part of the initial device development for the base glove. The country of origin of the data is not specified, but the applicant is based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the tests performed are objective, laboratory-based chemical and physical property tests, not interpretive studies requiring human expert assessment (like image analysis or clinical diagnosis). The "ground truth" is established by direct measurement of permeation time or other physical/chemical properties according to standardized methods.
4. Adjudication Method for the Test Set
This information is not applicable. As these are laboratory measurements, there is no adjudication method in the sense of reconciling different expert opinions. The results are quantitative measurements against a predefined standard. For instance, breakthrough time is measured directly using analytical techniques.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not conducted on the subject or predicate devices." The evaluation focuses on the physical and chemical resistance properties of the gloves, not on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device (surgical gloves) is a physical product and does not involve any artificial intelligence algorithms or software. The evaluation is solely on the physical and chemical properties of the gloves themselves.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Direct Physical and Chemical Measurements: For chemotherapy permeation, dimensions, physical properties, freedom from holes, powder residue, and sterility.
- Standardized Biological Assay Results: For biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity).
These are objective, quantitative results obtained through testing methods specified in internationally recognized standards (ASTM, ISO).
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product (surgical gloves) and does not involve any machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8. No training set or associated ground truth was required for the evaluation of this physical medical device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 22, 2019
Ansell Healthcare Products, LLC. Don Cronk Sr Manager, QARA / Technical Services 2301 Robb Drive Reno, Nevada 89523
Re: K182948
Trade/Device Name: Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: February 21, 2019 Received: February 21, 2019
Dear Don Cronk:
We have reviewed vour 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.
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
{1}------------------------------------------------
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.html; 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 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,
Clarence W. Murray lii III -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) K182948
Device Name
Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
Gammex PI Hybrid Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
| Test Chemotherapy drug & Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Bleomycin sulfate (15.0 mg/ml) | >240 |
| Busulfan (6.0 mg/ml) | >240 |
| Carboplatin (10.0 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 23.6 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Cytarabine (100.0 mg/ml) | >240 |
| Dacarbazine (10 mg/ml) | >240 |
| Daunorubicin (5.0 mg/ml) | >240 |
| Docetaxel (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Epirubicin (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fludarabine (25.0 mg/ml) | >240 |
| Fluorouracil(50.0 mg/ml) | >240 |
| Gemcitabine (Gemzar) (38.0 mg/ml) | >240 |
| Idarubicin (1.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Irinotecan (20.0 mg/ml) | >240 |
| Mechlorethamine HCl(1.0 mg/ml) | >240 |
| Melphalan (5.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Oxaliplatin (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Rituximab (10.0 mg/ml) | >240 |
| ThioTEPA (10.0 mg/ml) | 36.1 |
| Vincristine Sulfate(1.0 mg/ml) | >240 |
{3}------------------------------------------------
Prescription Use (Part 21 CFR 801 Subpart D)
- X Over-The-Counter Use (21 CFR 801 Subpart C)
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{4}------------------------------------------------
510k Summary K182948
Submitter
Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 USA
Contact Person:
Don Cronk Associate Director, Regulatory Affairs Americas Phone: 775-470-7106 don.cronk@ansell.com
Date Prepared
March 14th 2019
Name of Device
| Trade Names: | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs |
|---|---|
| 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 |
| 510k: | K182948 |
Legally Marketed Predicate Device
K151694 – Gammex PI Hybrid Surgical Gloves
Device Description
Gammex Pl Hybrid Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic rubber blend of polyisoprene and polychoroprene. A polyurethane polymer coating is applied to the inner surface of the glove to make donning eay. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and effective for handling chemotherapy agents.
Indication for Use Statement
Gammex PI Hybrid Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
{5}------------------------------------------------
Chemotherapy drug Permeation (Average breakthrough detection time in minutes) (ASTM D6978-05)
| Test Chemotherapy drug & Concentration | Minimum Breakthrough Detection Time (Sample1,2,3)(mins) |
|---|---|
| Bleomycin sulfate (15.0 mg/ml) | >240 |
| Busulfan (6.0 mg/ml) | >240 |
| Carboplatin (10.0 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 23.6(23.8,26.5,23.6) |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Cytarabine (100.0 mg/ml) | >240 |
| Dacarbazine (10 mg/ml) | >240 |
| Daunorubicin (5.0 mg/ml) | >240 |
| Docetaxel (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Epirubicin (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fludarabine (25.0 mg/ml) | >240 |
| Fluorouracil(50.0 mg/ml) | >240 |
| Gemcitabine (Gemzar) (38.0 mg/ml) | >240 |
| Idarubicin (1.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Irinotecan (20.0 mg/ml) | >240 |
| Mechlorethamine HCl(1.0 mg/ml) | >240 |
| Melphalan (5.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Oxaliplatin (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Rituximab (10.0 mg/ml) | >240 |
| ThioTEPA (10.0 mg/ml) | 36.1(36.1,37.0,36.7) |
| Vincrinstine Sulfate(1.0 mg/ml) | >240 |
| Vincrinstine Sulfate(1.0 mg/ml) | >240 |
{6}------------------------------------------------
| Predicate Device | Subject Device | Comparison | ||
|---|---|---|---|---|
| Trade Name | Gammex PI HybridSurgical Gloves | Gammex PI Hybrid Surgical Gloves Tested for Use withChemotherapy Drugs | Different | |
| 510(k) Number | K151694 | K182948 | Different | |
| Submitter | Ansell HealthcareProducts LLC | Ansell Healthcare Products LLC | Same | |
| Product Code | KGO | KGO | Same | |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same | |
| Regulation Name | Non-powderedSurgeon's Glove | Non-powdered Surgeon's Glove | Same | |
| Indications for Use | These gloves areintended to be wornby operating roompersonnel to protecta surgical woundfromcontamination. | Gammex PI Hybrid Surgical Gloves are intended to be wornby operating room personnel to protect a surgical woundfrom contamination. These gloves were tested for use withChemotherapy Drugs as per ASTM D6978-05. StandardPractice for Assessment of Medical Gloves to Permeation byChemotherapy Drugs.Tested chemotherapy drugs are as follows: | Similar with theexception of thechemotherapy claim | |
| Test Chemotherapy drug &Concentration | MinimumBreakthroughDetectionTime | |||
| Bleomycin sulfate(15.0 mg/ml) | >240 | |||
| Busulfan(6.0 mg/ml) | >240 | |||
| Carboplatin(10.0 mg/ml) | >240 | |||
| Carmustine(3.3 mg/ml) | 23.6 | |||
| Cisplatin(1.0 mg/ml) | >240 | |||
| Cyclophosphamide(20.0 mg/ml) | >240 | |||
| Cytarabine(100.0 mg/ml) | >240 | |||
| Dacarbazine(10 mg/ml) | >240 | |||
| Daunorubicin(5.0 mg/ml) | >240 | |||
| Docetaxel(10.0 mg/ml) | >240 | |||
| Doxorubicin Hydrochloride(2.0 mg/ml) | >240 | |||
| Epirubicin(2.0 mg/ml) | >240 | |||
| Fludarabine(20.0 mg/ml) | >240 | |||
| Fluorouracil(25.0 mg/ml) | >240 | |||
| Gemcitabine (Gemzar)(38.0 mg/ml) | >240 | |||
| Idarubicin(1.0 mg/ml) | >240 | |||
| Ifosfamide(50.0 mg/ml) | >240 | |||
| Irinotecan(20.0 mg/ml) | >240 | |||
| Mechlorethamine HCl(1.0 mg/ml) | >240 | |||
| Melphalan(5.0 mg/ml) | >240 | |||
| Methotrexate(25.0 mg/ml) | >240 | |||
| Mitomycin C(0.5 mg/ml) | >240 | |||
| Mitoxantrone(2.0 mg/ml) | >240 | |||
| Oxaliplatin(2.0 mg/ml) | >240 | |||
| Paclitaxel (Taxol)(6.0 mg/ml) | >240 | |||
| Rituximab(10.0 mg/ml) | >240 | |||
| ThioTEPA(10.0 mg/ml) | 36.1 | |||
| Vincrinstine Sulfate(1.0 mg/ml) | >240 | |||
| Prescription orOver- The Counter-Use | Over-The-Counter-Use | Over-The-Counter-Use | Same | |
| Materials | Synthetic rubber blend ofpolyisoprene andpolychloroprene | Synthetic rubber blend of polyisoprene andpolychloroprene | Same | |
| Coating | Polyurethane polymerinner coating to aiddonning | Polyurethane polymer inner coating to aid donning | Same | |
| 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 | White | White | Same | |
| Dimensions andphysical properties | Meets ASTM D3577 | Meets ASTM D3577 | Same | |
| Sterility | Sterile | Sterile | Same | |
| Sterilization method | Radiation | Radiation | Same | |
| Sterility Assurance Level(SAL) | 10-6 SAL | 10-6 SAL | Same | |
| Freedom from holes | Meets ASTM D3577-09(2015)Inspection level/AQL: GI/AQL 0.65 (multiple samplingplan)Lot Size: 35,001 to 150,000piecesSample size: 100 piecesAccept number: 0Actual found: 0 | Meets ASTM D3577-09(2015)Inspection level/AQL: GI/AQL0.65 (multiple sampling plan)Lot Size: 35,001 to 150,000piecesSample size: 100 piecesAccept number: 0Actual found: 0 | Same | |
| Powder-Free | Meets ASTM D 6124-06 Theaveraged residual powdercontent for the glove duringprocess validation is 0.48mgper glove | Meets ASTM D 6124-06 Theaveraged residual powdercontent for the glove duringprocess validation is 0.48mgper glove | Same | |
| Biocompatibility PrimarySkin IrritationISO 10993-10:2010 | Under the conditions of the study(per ISO 10993-10), the device is notan irritant | Under the conditions of the study(per ISO 10993-10), the device is notan irritant | Same | |
| Biocompatibility DermalSensitization - ISO 10993-10:2010 | Under the conditions of the study(per ISO 10993-10), not a sensitizer | Under the conditions of the study (perISO 10993-10), not a sensitizer | Same | |
| Biocompatibility Acute SystemicToxicity - ISO 10993-11: 2006 | Under the conditions of the study,there was no mortality or evidenceof systemic toxicity | Under the conditions of the study,there was no mortality or evidenceof systemic toxicity | Same | |
| Shelf Life | 3 years | 3 years | Same |
{7}------------------------------------------------
{8}------------------------------------------------
The subject device is manufactured from synthetic rubber blend of polyisoprene with polyurethane polymer inner coating to aid donning. The predicate device is manufactured from the same formulation. The subject device's materials are functionally equivalent to those of the subject device is identical to the prior cleared version of the device in all regards with the exception of the chemotherapy claims found within the Indications for Use.
The subject device meets the applicable requirements for surgeon's gloves with regard to dimensions and sizes, physical properties, freedom from holes, powder residues, and protein content as found in the following standards: ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization, irritation, and acute systemic toxicity in accord with the ISO 10993-10 and ISO 10993-11.
Non-Clinical Summary:
A clinical study was not conducted on the subject or predicate devices.
Technological Characteristics
Gammex PI Hybrid Surgical Gloves, tested for use with chemotherapy drugs, have the following technological characteristics as compared to ASTM or equivalent standards:
{9}------------------------------------------------
| Technological Characteristics | Standard/Test/FDA Guidance | Result Summary |
|---|---|---|
| Dimensions | ASTM D3577-09 | Meets ASTM D3577-09 requirements for length, width and thickness |
| Length | Minimum 265mm | Average 303mm |
| Palm Width(size) | (mm) | Average value in mm |
| 5.5 | 70±6 | 75 |
| 6 | 76±6 | 80 |
| 6.5 | 83±6 | 85 |
| 7 | 89±6 | 91 |
| 7.5 | 95±6 | 97 |
| 8 | 102±6 | 103 |
| 8.5 | 108±6 | 112 |
| 9 | 114±6 | 117 |
| Thickness | (mm) | Average value in mm |
| Finger | Minimum 0.10 | 0.22 |
| Palm | Minimum 0.10 | 0.2 |
| Cuff | Minimum 0.10 | 0.15 |
| Physical Properties | ASTM D3577-09 | Meets ASTM D3577-09 requirements for tensile strength and elongation at breakbefore and after accelerated aging |
| Freedom from holes | ASTM D3577-09ASTM D5151-06 | Meets ASTM D3577-09 and ASTM D5151-06 requirements of AQL 1.5 |
| Powder-Free | ASTM D3577-09ASTM 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, the device extract was found to be cytotoxic and therefore the device extracts were evaluated by ISO 10993-11 - Test for systemic toxicity. From the Acute Systemic Toxicity device extracts, the device extracts did not elicit a systemic response in the animal model |
| ISO Skin Irritation Study | ISO 10993-10:2010 | 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 Systemic Toxicity Study | ISO 10993-11: 2006 | Under the conditions of the study, there was no mortality or evidence of systemic toxicity |
| Chemotherapy Permeation Standard | ASTM D6978 - 05(2013) | Under the conditions of the study, the permeation is acceptable |
Conclusion
The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is as safe, as efferms as well as or better than the legally marketed device.
§ 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).