(183 days)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following chemicals have been tested with these gloves. (Table of chemotherapy drugs and breakthrough times) Fentanyl Citrate Injection 100mcg/2mL No breakthrough up to 240 minutes
This is a disposable polyisoprene surqical glove that is tested for use with chemotherapy drugs and fentanyl. The device is composed of two layers which are not attached in the fingers or palm/back of hand region, but are attached in the cuff area. The outer layer of the glove is white and the inner layer is green. The glove is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 81/2 and 9, and is provided sterile. No shelf life is claimed.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
This document is a 510(k) premarket notification for a medical device (surgical gloves), which primarily relies on non-clinical testing to demonstrate substantial equivalence to a predicate device. Therefore, many of the questions related to clinical studies, expert-based ground truth, and human-in-the-loop performance are not applicable (N/A) in this context.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic/Test Method | Standard/Purpose of Testing | Acceptance Criteria | Reported Device Performance (K230578) |
|---|---|---|---|
| Physical Properties | |||
| Before Aging Outer Layer: Tensile Strength | ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers) | Min. 17MPa | Pass (Meets) |
| Before Aging Outer Layer: Ultimate Elongation | ASTM D412 | Min. 650% | Pass (Meets) |
| Before Aging Outer Layer: Stress at 500% Elongation | ASTM D412 | Max. 7.0MPa | Pass (Meets) |
| After Aging Outer Layer: Tensile Strength | ASTM D412 | Min. 12MPa | Pass (Meets) |
| After Aging Outer Layer: Ultimate Elongation | ASTM D412 | Min. 490% | Pass (Meets) |
| Before Aging Inner Layer: Tensile Strength | ASTM D412 | Min. 17MPa | Pass (Meets) |
| Before Aging Inner Layer: Ultimate Elongation | ASTM D412 | Min. 650% | Pass (Meets) |
| Before Aging Inner Layer: Stress at 500% Elongation | ASTM D412 | Max. 7.0MPa | Pass (Meets) |
| After Aging Inner Layer: Tensile Strength | ASTM D412 | Min. 12MPa | Pass (Meets) |
| After Aging Inner Layer: Ultimate Elongation | ASTM D412 | Min. 490% | Pass (Meets) |
| Before Aging Cuff Region: Tensile Strength | ASTM D412 | Min. 17MPa | Pass (Meets) |
| Before Aging Cuff Region: Ultimate Elongation | ASTM D412 | Min. 650% | Pass (Meets) |
| Before Aging Cuff Region: Stress at 500% Elongation | ASTM D412 | Max. 7.0MPa | Pass (Meets) |
| After Aging Cuff Region: Tensile Strength | ASTM D412 | Min. 12MPa | Pass (Meets) |
| After Aging Cuff Region: Ultimate Elongation | ASTM D412 | Min. 490% | Pass (Meets) |
| Dimension (Length, Width, Thickness) | ASTM D3767 (Standard Practice for Rubber - Measurement of Dimensions) | Each size satisfies ASTM requirement (specific ranges listed for each size, e.g., 5½: Min. 245mm length, 70 ± 6 mm width) | Pass (Each size satisfies ASTM requirement) |
| Watertight | ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves) | Freedom from holes AQL 1.5 | Pass |
| Residual Powder | ASTM D6124 (Standard Test Method for Residual Powder and non-powder solids on Medical Gloves) | Have a powder residue below 2.0 mg per glove | Pass |
| Biocompatibility: Primary Skin Irritation | ISO 10993-10 (E) | Under the conditions of the study, not an irritant | Pass (Not an irritant) |
| Biocompatibility: Dermal Sensitization | ISO 10993-10 (E) | Under the conditions of the study, not a sensitizer | Pass (Not a sensitizer) |
| Biocompatibility: Acute Systemic Toxicity | ISO 10993-11 (E) | Under the conditions of the study, no acute systemic toxicity | Pass (No acute systemic toxicity) |
| Biocompatibility: Material Mediated Pyrogenicity | ISO 10993-11 (E) | Under the conditions of the study, non-pyrogenic | Pass (Non-pyrogenic) |
| Biocompatibility: Bacterial Endotoxins | LAL Gel Clot, ANSI/AAMI CT73 | ≤20 EU/device | Pass |
| Chemotherapy Drug Permeation (ASTM D6978-05) | Minimum Breakthrough Detection Time for specific drugs (see Chemo Drug Permeation table) | Varies by drug (e.g., Carmustine: 67.6 min, Cisplatin: > 240 min, Thiotepa: 77.7 min) | |
| Fentanyl Resistant (ASTM D6978-05) | No breakthrough up to 240 minutes for Fentanyl Citrate Injection (100mcg/2mL) | No breakthrough up to 240 minutes |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical test (e.g., how many gloves were tested for tensile strength or dimensional analysis). It refers to standard test methods (e.g., ASTM D412, ASTM D3767, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11, ASTM D6978-05), which inherently define the required sample sizes for conducting those tests to achieve statistically valid results according to their respective standards. The data provenance is Malaysia, as the submitter (WRP Asia Pacific Sdn. Bhd.) is located in Malaysia. The testing is retrospective, conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This device's performance is established through objective, standardized physical and chemical testing, not expert interpretation of cases or images.
4. Adjudication method for the test set
N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers, where there's subjectivity in interpretation. This is not relevant for the objective physical and chemical tests performed on the surgical gloves.
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
N/A. This is not an AI-assisted device. The device itself is a surgical glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an algorithm or AI-based device.
7. The type of ground truth used
The "ground truth" for the performance of the surgical gloves is established by objective measurements against established industry standards and regulatory requirements. For example:
- Physical Properties: Measured tensile strength, elongation, and stress values are compared against minimum/maximum thresholds defined by ASTM D3577 and D412.
- Dimensions: Measured lengths, widths, and thicknesses are compared against specified ASTM D3577 requirements for each glove size.
- Watertightness: The number of detected holes is compared against the Acceptable Quality Limit (AQL) of 1.5 as per ASTM D5151 and D3577.
- Residual Powder: The measured powder residue is compared against the limit of ≤2.0 mg/glove as per ASTM D6124 and D3577.
- Biocompatibility: Biological responses (irritation, sensitization, systemic toxicity, pyrogenicity) are evaluated against the criteria for "Pass" as defined by ISO 10993-10 and ISO 10993-11.
- Chemotherapy Drug Permeation and Fentanyl Resistance: The breakthrough detection times are measured according to ASTM D6978 and compared against established timeframes.
8. The sample size for the training set
N/A. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
N/A. Not applicable as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
August 31, 2023
WRP Asia Pacific Sdn. Bhd. % Michael Scaglione U.S. Agent WRP USA Inc 3700 Massillon Road, Suite 340 Uniontown, Ohio 44685
Re: K230578
Trade/Device Name: Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I. reserved Product Code: KGO, LZC, OPJ, QDO Dated: July 24, 2023 Received: August 1, 2023
Dear Michael Scaglione:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian -S
BiFeng Oian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K230578
Device Name
Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
Indications for Use (Describe)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation The following chemicals have been tested with these gloves.
| Chemotherapy Drug (Concentration) | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| *Carmustine (BCNU) (3.3 mg/ml) | 67.6 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| *Thiotepa (10.0 mg/ml) | 77.7 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 67.6 minutes and Thiotepa: 77.7. Do not use with Carmustine and Thiotepa.
| Fentanyl | ||
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240 minutes |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{3}------------------------------------------------
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Date of Preparation: August 31, 2023
1.0 Submitter:
| Name | : Saravanan Ramasamy |
|---|---|
| Address | : WRP Asia Pacific Sdn. Bhd.Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru SalakTinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No. | : +60 3 8706 1486 |
| Fax No. | : +60 3 8706 1557 |
2.0 Identification of the Subject Device:
| Trade Name | : | Polyisoprene Surgical Glove (Unified Double Layer),Sterile, Tested for Use with Chemotherapy Drugs andFentanyl |
|---|---|---|
| Common Name | : | Surgical Gloves |
| Classification Name | : | Non-powdered Surgeon's Glove |
| Device Classification | : | I |
| Regulation Number | : | 21 CFR 878.4460 |
| Product Code | : | KGO, LZC, OPJ, QDO |
3.0 Predicate Device:
| Predicate | |
|---|---|
| Manufacturer | WRP Asia Pacific Sdn. Bhd. |
| Device name | Polyisoprene Surgical Glove, Powder Free,Sterile, Tested for Use with Chemotherapy Drugsand Fentanyl Resistance |
| 510(k) Number | K222058 |
| Regulatory Class | I |
| Product Code | KGO, LZC, OPJ |
4.0 Description of The Device:
This is a disposable polyisoprene surqical glove that is tested for use with chemotherapy drugs and fentanyl. The device is composed of two layers which are not attached in the fingers or palm/back of hand region, but are attached in the cuff area. The outer layer of the glove is white and the inner layer is green. The glove is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 81/2 and 9, and is provided sterile. No shelf life is claimed.
5.0 Indication for use:
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier
{5}------------------------------------------------
for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
| Chemotherapy Drug | Concentration | MinimumBreakthroughDetection Time(Minutes) |
|---|---|---|
| *Carmustine (BCNU) | 3.3 mg/ml | 67.6 |
| Cisplatin | 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Ifosfamide | 50.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |
| Mitoxantrone | 2.0 mg/ml | > 240 |
| Paclitaxel | 6.0 mg/ml | > 240 |
| *Thiotepa | 10.0 mg/ml | 77.7 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |
*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 67.6 minutes and Thiotepa: 77.7. Do not use with Carmustine and Thiotepa.
| Fentanyl | Concentration | Breakthrough DetectionTime in Minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240minutes |
6.0 Summary of the Technological Characteristics of the Device: See table
{6}------------------------------------------------
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | PREDICATEK222058 | CURRENTK230578 | COMPARISONANALYSIS | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| 510(k) Number | - | |||||||||
| Manufacturer(s) | - | WRP Asia Pacific Sdn. Bhd. | WRP Asia Pacific Sdn. Bhd. | Same | ||||||
| Material | ASTM D3577 | Polyisoprene Rubber | Polyisoprene Rubber | Same | ||||||
| Color | - | Natural White | Green and White | Different | ||||||
| Texture | - | Bisque Finish | Bisque Finish | Same | ||||||
| Physical Properties | ASTM D3577 | Meets | Meets | Same | ||||||
| Before AgingTensile Strength:UltimateElongation: Stressat 500%Elongation: | Min. 17MPa Min. 650%Max. 7.0MPa | Min. 17MPa Min. 650%Max. 7.0MPa | ||||||||
| After Aging TensileStrength: UltimateElongation: Stressat 500%Elongation: | MeetsMin. 12MPa Min. 490%N/A | MeetsMin. 12MPa Min. 490%N/A | Same | |||||||
| Thickness:- Finger- Palm- Cuff | ASTM D3577 | MeetsMin. 0.10 mmMin. 0.10 mmMin. 0.10 mm | MeetsMin. 0.10 mmMin. 0.10 mmMin. 0.10 mm | Same | ||||||
| Dimension, Length | ASTM D3577 | Meets5½: Min. 245mm 6.0: Min. 265 mm 6½: Min. 265 mm7.0: Min. 265 mm 7½: Min. 265 mm 8.0: Min. 265 mm8½: Min. 265 mm9.0: Min. 265 mm | Meets5½: Min. 245mm 6.0: Min. 265 mm 6½: Min. 265 mm 7.0: Min. 265 mm7½: Min. 265 mm 8.0: Min. 265 mm 8½: Min. 265 mm9.0: Min. 265 mm | Same | ||||||
| Dimension, Width | ASTM D3577 | Meets5½: 70 ± 6 mm6.0: 76 ± 6 mm6½: 83 ± 6 mm7.0: 89 ± 6 mm7½: 95 ± 6 mm8.0: 102 ± 6 mm8½: 108 ± 6 mm9.0: 114 ± 6 mm | Meets5½: 70 ± 6 mm6.0: 76 ± 6 mm6½: 83 ± 6 mm7.0: 89 ± 6 mm7½: 95 ± 6 mm8.0: 102 ± 6 mm8½: 108 ± 6 mm9.0: 114 ± 6 mm | Same | ||||||
| Powder Free | ASTM D6124 | Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577 | Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577 | Same | ||||||
| Biocompatibility | ||||||||||
| Primary SkinIrritation - ISO10993-10 (E) | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant | Same | |||||||
| DermalSensitization-ISO 10993-10(E) | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Same | |||||||
| Acute SystemicToxicity, ISO10993-11 (E) | Under the conditions of the study, no evidence of acute systemic toxicity observed | Under the conditions of the study, no evidence of acute systemic toxicity observed | Similar | |||||||
| MaterialMediatedPyrogenicity,ISO 10993-11 | ISO 10993-11(E) | Under the conditions of the study, no evidence of material mediated pyrogenicity | Under the conditions of the study, no evidence of material mediated pyrogenicity | Similar | ||||||
| BacterialEndotoxins | Not available | $\leq$ 20 EU/device | Different | |||||||
| ANSI/AAMIST72 | ||||||||||
| Watertight(1000ml) | ASTM D5151 | ASTM D3577 when tested in accordance with ASTM D5151 | ASTM D3577 when tested in accordance with ASTM D5151 | Same | ||||||
| Intended use /Indications for Use | A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:Chemotherapy Drug Concentration Average Breakthrough Detection Time (Minutes)*Carmustine (BCNU) (3.3 mg/ml) 24.0Cisplatin (1.0 mg/ml) > 240Cyclophosphamide (Cytoxan) (20.0 mg/ml) > 240Dacarbazine (10.0 mg/ml) > 240Doxorubicin Hydrochloride (2.0 mg/ml) > 240Etoposide (20.0 mg/ml) > 240Fluorouracil (50.0 mg/ml) > 240Ifosfamide (50.0 mg/ml) > 240Methotrexate (25.0 mg/ml) > 240Mitomycin C (0.5 mg/ml) > 240Mitoxantrone (2.0 mg/ml) > 240Paclitaxel (6.0 mg/ml) > 240*ThioTepa (10.0 mg/ml) 23.1Vincristine Sulfate (1.0 mg/ml) > 240*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 24.0 minutes and Thiotepa: 23.1. Do not use with Carmustine and Thiotepa | Fentanyl Citrate Injection(100mcg/2mL) Nobreakthrough up to 240minutes | A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:Chemotherapy Drug (Concentration) Minimum Breakthrough Detection Time (Minutes)*Carmustine (BCNU) (3.3 mg/ml) 67.6Cisplatin (1.0 mg/ml) > 240Cyclophosphamide (Cytoxan) (20.0 mg/ml) > 240Dacarbazine (10.0 mg/ml) > 240Doxorubicin Hydrochloride (2.0 mg/ml) > 240Etoposide (20.0 mg/ml) > 240Fluorouracil (50.0 mg/ml) > 240Ifosfamide (50.0 mg/ml) > 240Methotrexate (25.0 mg/ml) > 240Mitomycin C (0.5 mg/ml) > 240Mitoxantrone (2.0 mg/ml) > 240Paclitaxel (6.0 mg/ml) > 240*Thiotepa (10.0 mg/ml) 77.7Vincristine Sulfate (1.0 mg/ml) > 240*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 67.6 | minutes and Thiotepa: 77.7.Do not use with Carmustineand Thiotepa.FentanylBreakthrough Detection Time inMinutes | Similar |
{7}------------------------------------------------
{8}------------------------------------------------
| Fentanyl Citrate InjectionNo breakthrough up to 240 minutes | ||||
|---|---|---|---|---|
| Size | Medical GloveGuidanceManual -Labeling | 5½6.06½7.07½8.08½9.0 | 5½6.06½7.07½8.08½9.0 | Same |
| Single Use | Medical GloveGuidanceManual -Labeling | Single use | Single use | Same |
| Sterility Status | Medical GloveGuidanceManualLabeling | Sterile (SAL 10-6) | Sterile (SAL 10-6) | Same |
| Sterility Method | ISO 11137-1ISO 11137-2 | Gamma Radiation | Gamma Radiation | Same |
| ChemotherapyDrug PermeationTest | ASTM D6978-05 | |||
| * Carmustine (BCNU)(3.3 mg/ml) | 24.0 | 67.6 | Similar | |
| Cisplatin (1.0 mg/ml) | > 240 | >240 | Same | |
| Cyclophosphamide(Cytoxan) (20.0mg/ml) | > 240 | >240 | Same | |
| Dacarbazine (10.0mg/ml) | > 240 | > 240 | Same | |
| DoxorubicinHydrochloride (2.0mg/ml) | > 240 | > 240 | Same | |
| Etoposide (20.0mg/ml) | > 240 | > 240 | Same | |
| Fluorouracil (50.0mg/ml) | > 240 | > 240 | Same | |
| Ifosfamide (50.0mg/ml) | > 240 | > 240 | Same | |
| Methotrexate (25.0mg/ml) | > 240 | > 240 | Same | |
| Mitomycin C (0.5mg/ml) | > 240 | > 240 | Same | |
| Mitoxantrone (2.0mg/ml) | > 240 | > 240 | Same | |
| Paclitaxel (6.0mg/ml) | > 240 | > 240 | Same | |
| * ThioTepa (10.0mg/ml) | 23.1 | 77.7 | Similar | |
| Vincristine Sulfate(1.0 mg/ml) | > 240 | > 240 | Same | |
| Warning Statement | WARNING: Please note thefollowing drugs haveextremely low permeationtimes: Carmustine (BCNU):24.0minutes andThiotepa: 23.1. Do not usewith Carmustine and Thiotepa | *WARNING:Please note the following drugshave extremely low permeationtimes: Carmustine (BCNU): 67.6minutes andThiotepa: 77.7. Do not use withCarmustine and Thiotepa. | Similar | |
| Fentanyl Resistant | ASTM D6978-05 | > 240 | > 240 | Same |
{9}------------------------------------------------
Summary of Non-Clinical Testing 7.0
The performance test data of the non-clinical test for this subject glove is summarized as per below.
| Test Method | Standard | Purpose ofTesting | Acceptance Criteria | Results |
|---|---|---|---|---|
| PhysicalProperties | ASTM D412(Standard TestMethod forVulcanizedRubber andThermoplasticElastomers -Tension) | To evaluate thetensile(tension)propertiesof glove | Before Aging Outer LayerTensile strength Min. 17MPa | Pass |
| Ultimateelongation Min. 650% | Pass | |||
| Stress at 500% Max. 7.0MPaElongation | Pass | |||
| After Aging Outer Layer | ||||
| Tensilestrength Min. 12MPa | Pass | |||
| Ultimateelongation Min. 490% | Pass | |||
| Before Aging Inner Layer | ||||
| Tensilestrength Min. 17MPa | Pass | |||
| Ultimateelongation Min. 650% | Pass | |||
| Stress at 500% Max. 7.0MPaElongation | Pass | |||
| After Aging Inner Layer | ||||
| Tensilestrength Min. 12MPa | Pass | |||
| Ultimateelongation Min. 490% | Pass | |||
| Before Aging Cuff Region | ||||
| Tensilestrength Min. 17MPa | Pass | |||
| Ultimateelongation Min. 650% | Pass | |||
| Stress at 500% Max. 7.0MPaElongation | Pass | |||
| After Aging Cuff Region | ||||
| Tensilestrength Min. 12MPa | Pass | |||
| Ultimateelongation Min. 490% | Pass | |||
| Dimension | ASTM D3767(StandardPractice forRubber -Measurement ofDimensions) | To measure thelength, widthand thicknessof glove | Length: Each size satisfies ASTMrequirementWidth: Each size satisfies ASTMrequirement | Pass |
| Dimension | ASTM D3767(StandardPractice forRubber -Measurement ofDimensions) | To measure thelength, widthand thicknessof glove | Thickness: Each size satisfiesASTM requirement | Pass |
| Watertight | ASTM D5151(Standard TestMethod forDetection ofHolesin MedicalGloves) | To measureglove integrity | Freedom from holes AQL 1.5 | Pass |
| ResidualPowder | ASTM D6124(Standard TestMethod forResidual Powderand non-powder solidson MedicalGloves) | To determinethe amount ofresidual powderand non-powder solidsfound on gloves | Have a powder residue below 2.0mg per glove | Pass |
| Biocompatibility | Primary SkinIrritation - ISO10993-10 (E) | To assess thepotential ofglove toproduce dermalirritation | Under the conditions of the study,not an irritant | Pass |
| Biocompatibility | DermalSensitization-ISO 10993-10(E) | To assess thepotential ofglove to causedermalsensitization | Under the conditions of the study,not a sensitizer | Pass |
| Biocompatibility | Acute SystemicToxicity, ISO10993-11 (E) | To determinethe acutesystemictoxicitypotential ofglove | Under the conditions of the study,no acute systemic toxicity | Pass |
| Biocompatibility | MaterialMediatedPyrogenicity,ISO 10993-11(E) | To determineanypyrogenicresponseinduced by theglove material | Under the conditions of the study,non-pyrogenic | Pass |
| LAL Gel ClotBacterialEndotoxinANSI/AAMICT73 | To determinethe endotoxinlevel on finalfinished gloves | ≤20 EU/device | Pass |
{10}------------------------------------------------
8.0 Summary of Clinical Testing:
No clinical study is included in this submission.
{11}------------------------------------------------
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrate that the subject device, Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl, is as safe, effective, and performs as well as or better than the legally marketed predicate device K222058.
§ 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).