(183 days)
No
The device description and performance studies focus on the physical properties and chemical resistance of a surgical glove, with no mention of AI or ML technologies.
No
The device is a surgeon's glove designed as a barrier for protection against cross-contamination, not for treating a disease or condition.
No
Explanation: The device is a surgical glove intended as a barrier for protection, not for diagnosing any medical condition. Its function is to prevent cross-contamination between healthcare personnel and patients.
No
The device description clearly states it is a disposable polyisoprene surgical glove, which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a barrier for protection against cross-contamination between healthcare personnel and patients. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a surgical glove, designed to be worn on the hands. It does not involve any reagents, instruments, or procedures for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the glove (tensile strength, watertightness, etc.), biocompatibility, and resistance to chemicals (chemotherapy drugs and fentanyl). These are all related to the glove's function as a protective barrier, not its ability to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
In summary, this device is a medical device intended for personal protection, not for performing in vitro diagnostic tests.
N/A
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 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 |
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC, OPJ, QDO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare 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)
The submission includes non-clinical performance test data, but does not provide details such as sample size for each test. The tests performed include:
- Physical Properties (ASTM D412): Evaluated tensile properties of the glove (Tensile strength, Ultimate elongation, Stress at 500% elongation) both before and after aging for outer layer, inner layer, and cuff region. All parameters passed the specified acceptance criteria.
- Dimension (ASTM D3767): Measured length, width, and thickness of the glove. All dimensions for each size passed ASTM requirements.
- Watertight (ASTM D5151): Measured glove integrity, with a freedom from holes AQL of 1.5. Passed.
- Residual Powder (ASTM D6124): Determined the amount of residual powder and non-powder solids. Passed, with powder residue below 2.0 mg per glove.
- Biocompatibility:
- Primary Skin Irritation (ISO 10993-10 (E)): To assess potential for dermal irritation. Results indicated "not an irritant". Passed.
- Dermal Sensitization (ISO 10993-10 (E)): To assess potential for dermal sensitization. Results indicated "not a sensitizer". Passed.
- Acute Systemic Toxicity (ISO 10993-11 (E)): To determine acute systemic toxicity potential. Results indicated "no acute systemic toxicity". Passed.
- Material Mediated Pyrogenicity (ISO 10993-11 (E)): To determine pyrogenic response induced by glove material. Results indicated "non-pyrogenic". Passed.
- Bacterial Endotoxin (LAL Gel Clot, ANSI/AAMI CT73): To determine endotoxin level. Results indicated "≤20 EU/device". Passed.
- Chemotherapy Drug Permeation Test (ASTM D6978-05): Tested permeation for various chemotherapy drugs, including Carmustine (BCNU), Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, Etoposide, Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel, ThioTepa, and Vincristine Sulfate. Minimum breakthrough detection times were provided, with a warning for Carmustine and Thiotepa due to low permeation times.
- Fentanyl Resistant (ASTM D6978-05): No breakthrough up to 240 minutes.
No clinical study was included in the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Performance metrics provided are physical properties, chemical permeation times, and biocompatibility results.
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 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
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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 Salak | |
| Tinggi, 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 and
Fentanyl |
|-----------------------|---|------------------------------------------------------------------------------------------------------------------------|
| 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 Drugs | |
| and 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 | 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 | Concentration | Breakthrough Detection
Time in Minutes |
|----------------------------|---------------|-------------------------------------------|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240
minutes |
6.0 Summary of the Technological Characteristics of the Device: See table
6
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | PREDICATE
K222058 | CURRENT
K230578 | COMPARISON
ANALYSIS | | | | | |
|-----------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--|---------|
| 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 Aging
Tensile Strength:
Ultimate
Elongation: Stress
at 500%
Elongation: | | | Min. 17MPa Min. 650%
Max. 7.0MPa | Min. 17MPa Min. 650%
Max. 7.0MPa | | | | | | |
| After Aging Tensile
Strength: Ultimate
Elongation: Stress
at 500%
Elongation: | | | Meets
Min. 12MPa Min. 490%
N/A | Meets
Min. 12MPa Min. 490%
N/A | Same | | | | | |
| Thickness:
- Finger
- Palm
- Cuff | ASTM D3577 | | Meets
Min. 0.10 mm
Min. 0.10 mm
Min. 0.10 mm | Meets
Min. 0.10 mm
Min. 0.10 mm
Min. 0.10 mm | Same | | | | | |
| Dimension, Length | ASTM D3577 | | Meets
5½: Min. 245mm 6.0: Min. 265 mm 6½: Min. 265 mm
7.0: Min. 265 mm 7½: Min. 265 mm 8.0: Min. 265 mm
8½: Min. 265 mm
9.0: Min. 265 mm | Meets
5½: Min. 245mm 6.0: Min. 265 mm 6½: Min. 265 mm 7.0: Min. 265 mm
7½: Min. 265 mm 8.0: Min. 265 mm 8½: Min. 265 mm
9.0: Min. 265 mm | Same | | | | | |
| Dimension, Width | ASTM D3577 | | Meets
5½: 70 ± 6 mm
6.0: 76 ± 6 mm
6½: 83 ± 6 mm
7.0: 89 ± 6 mm
7½: 95 ± 6 mm
8.0: 102 ± 6 mm
8½: 108 ± 6 mm
9.0: 114 ± 6 mm | Meets
5½: 70 ± 6 mm
6.0: 76 ± 6 mm
6½: 83 ± 6 mm
7.0: 89 ± 6 mm
7½: 95 ± 6 mm
8.0: 102 ± 6 mm
8½: 108 ± 6 mm
9.0: 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 Skin
Irritation - ISO
10993-10 (E) | | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant | Same | | | | | |
| | Dermal
Sensitization-
ISO 10993-10
(E) | | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Same | | | | | |
| | Acute Systemic
Toxicity, ISO
10993-11 (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 | | | | | |
| | | Material
Mediated
Pyrogenicity,
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 |
| | Bacterial
Endotoxins | Not available | $\leq$ 20 EU/device | Different | | | | | | |
| | ANSI/AAMI
ST72 | | | | | | | | | |
| 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) 24.0
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) 23.1
Vincristine 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) No
breakthrough up to 240
minutes | 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) 67.6
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
Breakthrough Detection Time in
Minutes | Similar | | |
7
8
| | | | Fentanyl Citrate Injection
No breakthrough up to 240 minutes | |
|-----------------------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Size | Medical Glove
Guidance
Manual -
Labeling | 5½
6.0
6½
7.0
7½
8.0
8½
9.0 | 5½
6.0
6½
7.0
7½
8.0
8½
9.0 | Same |
| Single Use | Medical Glove
Guidance
Manual -
Labeling | Single use | Single use | Same |
| Sterility Status | Medical Glove
Guidance
Manual
Labeling | Sterile (SAL 10-6) | Sterile (SAL 10-6) | Same |
| Sterility Method | ISO 11137-1
ISO 11137-2 | Gamma Radiation | Gamma Radiation | Same |
| Chemotherapy
Drug Permeation
Test | ASTM D6978-
05 | | | |
| * Carmustine (BCNU)
(3.3 mg/ml) | | 24.0 | 67.6 | Similar |
| Cisplatin (1.0 mg/ml) | | > 240 | >240 | Same |
| Cyclophosphamide
(Cytoxan) (20.0
mg/ml) | | > 240 | >240 | Same |
| Dacarbazine (10.0
mg/ml) | | > 240 | > 240 | Same |
| Doxorubicin
Hydrochloride (2.0
mg/ml) | | > 240 | > 240 | Same |
| Etoposide (20.0
mg/ml) | | > 240 | > 240 | Same |
| Fluorouracil (50.0
mg/ml) | | > 240 | > 240 | Same |
| Ifosfamide (50.0
mg/ml) | | > 240 | > 240 | Same |
| Methotrexate (25.0
mg/ml) | | > 240 | > 240 | Same |
| Mitomycin C (0.5
mg/ml) | | > 240 | > 240 | Same |
| Mitoxantrone (2.0
mg/ml) | | > 240 | > 240 | Same |
| Paclitaxel (6.0
mg/ml) | | > 240 | > 240 | Same |
| * ThioTepa (10.0
mg/ml) | | 23.1 | 77.7 | Similar |
| Vincristine Sulfate
(1.0 mg/ml) | | > 240 | > 240 | Same |
| Warning Statement | | 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 | *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. | 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 of
Testing | Acceptance Criteria | Results |
|------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------|
| Physical
Properties | ASTM D412
(Standard Test
Method for
Vulcanized
Rubber and
Thermoplastic
Elastomers -
Tension) | To evaluate the
tensile
(tension)
properties
of glove | Before Aging Outer Layer
Tensile strength Min. 17MPa | Pass |
| | | | Ultimate
elongation Min. 650% | Pass |
| | | | Stress at 500% Max. 7.0MPa
Elongation | Pass |
| | | | After Aging Outer Layer | |
| | | | Tensile
strength Min. 12MPa | Pass |
| | | | Ultimate
elongation Min. 490% | Pass |
| | | | Before Aging Inner Layer | |
| | | | Tensile
strength Min. 17MPa | Pass |
| | | | Ultimate
elongation Min. 650% | Pass |
| | | | Stress at 500% Max. 7.0MPa
Elongation | Pass |
| | | | After Aging Inner Layer | |
| | | | Tensile
strength Min. 12MPa | Pass |
| | | | Ultimate
elongation Min. 490% | Pass |
| | | | Before Aging Cuff Region | |
| | | | Tensile
strength Min. 17MPa | Pass |
| | | | Ultimate
elongation Min. 650% | Pass |
| | | | Stress at 500% Max. 7.0MPa
Elongation | Pass |
| | | | After Aging Cuff Region | |
| | | | Tensile
strength Min. 12MPa | Pass |
| | | | Ultimate
elongation Min. 490% | Pass |
| Dimension | ASTM D3767
(Standard
Practice for
Rubber -
Measurement of
Dimensions) | To measure the
length, width
and thickness
of glove | Length: Each size satisfies ASTM
requirement
Width: Each size satisfies ASTM
requirement | Pass |
| Dimension | ASTM D3767
(Standard
Practice for
Rubber -
Measurement of
Dimensions) | To measure the
length, width
and thickness
of glove | Thickness: Each size satisfies
ASTM requirement | Pass |
| Watertight | ASTM D5151
(Standard Test
Method for
Detection of
Holes
in Medical
Gloves) | To measure
glove integrity | Freedom from holes AQL 1.5 | Pass |
| Residual
Powder | ASTM D6124
(Standard Test
Method for
Residual Powder
and non-
powder solids
on Medical
Gloves) | To determine
the amount of
residual powder
and non-
powder solids
found on gloves | Have a powder residue below 2.0
mg per glove | Pass |
| Biocompatibili
ty | Primary Skin
Irritation - ISO
10993-10 (E) | To assess the
potential of
glove to
produce dermal
irritation | Under the conditions of the study,
not an irritant | Pass |
| Biocompatibili
ty | Dermal
Sensitization-
ISO 10993-10
(E) | To assess the
potential of
glove to cause
dermal
sensitization | Under the conditions of the study,
not a sensitizer | Pass |
| Biocompatibili
ty | Acute Systemic
Toxicity, ISO
10993-11 (E) | To determine
the acute
systemic
toxicity
potential of
glove | Under the conditions of the study,
no acute systemic toxicity | Pass |
| Biocompatibili
ty | Material
Mediated
Pyrogenicity,
ISO 10993-11
(E) | To determine
any
pyrogenic
response
induced by the
glove material | Under the conditions of the study,
non-pyrogenic | Pass |
| | LAL Gel Clot
Bacterial
Endotoxin
ANSI/AAMI
CT73 | To determine
the endotoxin
level on final
finished 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.