(259 days)
Not Found
No
The document describes a standard surgical glove and its performance characteristics, with no mention of AI or ML technology.
No
A surgical glove is a barrier for protection against cross-contamination, not a device that treats or ameliorates a disease or condition.
No
Explanation: A diagnostic device is used to diagnose diseases or conditions. The device described, a surgical glove, is intended as a barrier for protection and not for diagnostic purposes.
No
The device is a physical surgical glove, not a software application. The description focuses on material properties and physical testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "powder-free sterile surgeon's glove... intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient." This describes a physical barrier device used during medical procedures.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples such as blood, urine, or tissues taken from the human body to detect diseases, conditions, or infections.
- Device Description: The description focuses on the physical characteristics of the glove and its testing for resistance to chemotherapy drugs and fentanyl. It does not mention any testing of biological samples or diagnostic purposes.
- Performance Studies and Key Metrics: The performance studies and key metrics listed relate to the physical properties of the glove (strength, elongation, thickness, etc.), its integrity (freedom from holes), biocompatibility, and resistance to chemical permeation. None of these are related to diagnostic testing of patient samples.
In summary, this device is a personal protective equipment (PPE) and a barrier device used in a clinical setting, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A powder-free sterile surgeon's glove is a disposable device made of natural 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 and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
NATURAL RUBBER LATEX SURGICAL GLOVE, POWDER FREE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL (GREEN):
| Chemotherapy Drug | Concentration Average Breakthrough Detection Time (Minutes) |
|---|---|
| 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 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| *Thiotepa (10.0 mg/ml) | 14.7 |
| *Carmustine (BCNU) (3.3 mg/ml) | 11.9 |
| Opioid Drug | Fentanyl Citrate 100 mcg/2mL |
|---|---|
| Breakthrough Detection Time in Minutes | No breakthrough up to 240 minutes |
*WARNING: Testing showed an average breakthrough time of 11.9 minutes for Carmusine and an average breakthrough time of 14.7 minutes for Thiotepa. Do not use with Carmustine and Thiotepa.
NATURAL RUBBER LATEX (STRIP&COAT)/(STRIP&PACK) SURGICAL GLOVE, POWDER FREE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL:
| Chemotherapy Drug | Average Breakthrough Detection Time (Minutes) |
|---|---|
| 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 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| *Thiotepa (10.0 mg/ml) | 13.8 |
| *Carmustine (BCNU) (3.3 mg/ml) | 5.7 |
Opioid Drug Fentanyl Citrate 100 mcg/2mL Breakthrough Detection Time in Minutes No breakthrough up to 240 minutes
- WARNING: Testing showed an average breakthrough time of 5.7 minutes for Carmustine and an average breakthrough time of 13.8 minutes for Thiotepa. Do not use with Carmustine and Thiotepa.
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC, OPJ, QDO
Device Description
This is a disposable natural rubber surgical glove that is tested for use with chemotherapy drugs and fentanyl resistance. The glove is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9.
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)
Summary of Non-Clinical Testing:
| 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 | Tensile strength | Before Aging Min. 24MPa After Aging Min. 18MPa | Before Aging Pass | After Aging Pass |
| Ultimate elongation | Min. 750% Min. 560% | Pass | Pass | |||
| Stress at 500% Elongation | Max. 5.5MPa N/A | Pass | N/A | |||
| 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 | Finger - Min. 0.10 mm Palm - Min. 0.10 mm Cuff - Min. 0.10 mm | Pass | |
| Watertight | ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves) | To measure glove integrity | Freedom from holes at AQL 0.65 | Pass | ||
| Residual Powder | ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) | To determine the amount of residual powder and non-powder solids found on gloves | Have a powder residue limit of 2.0 mg per glove | Pass | ||
| Protein Content | ASTM D5712 (Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method) | To determine the amount of extractable protein from the glove | ≤ 200 µg/dm2 | Pass | ||
| Test Method | Standard | Purpose of Testing | Result Summary | |||
| Biocompatibility | Primary Skin Irritation - ISO 10993-10 | To assess the potential of glove to produce dermal irritation | Not a primary skin irritation | |||
| Biocompatibility | Dermal Sensitization- ISO 10993-10 | To assess the potential of glove to cause a delayed hypersensitivity (Type IV) immunological response | Not a contact sensitizer | |||
| Biocompatibility | Acute Systemic Toxicity, ISO 10993-11 | To determine the acute systemic toxicity potential of glove | No biological reactivity shown | |||
| Biocompatibility | Material Mediated Pyrogenicity, ISO 10993-11 | To determine any pyrogenic response induced by the glove | No increase of temperature | |||
| Biocompatibility | Cytotoxicity- Direct Contact, ISO 10993-5 | To determine the cytotoxicity potential of glove | Non-cytotoxic for S&C/S&P gloves | |||
| Biocompatibility | Cytotoxicity- MEM Elution, ISO 10993-5 | To determine the cytotoxicity potential of glove | Under the conditions of this study, the test article extract showed potential toxicity to L929 cells for Natural Rubber Latex Green | |||
| Bacterial endotoxin | Limulus Amoebocyte Lysate (LAL) test | To determine the amount of endotoxin on the glove | ≤20 EU/pair of gloves |
Summary of Clinical Testing:
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 28, 2024
WRP Asia Pacific Sdn. Bhd. % Michael Scaglione U.S. Agent WRP USA Inc 3700 Massillon Road, Suite 340 Uniontown, Ohio 44685
Re: K232079
Trade/Device Name: Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, 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: March 5, 2024 Received: March 26, 2024
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director
2
DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232079
Device Name
Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Slove, Powder Free, 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 natural 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 and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
NATURAL RUBBER LATEX SURGICAL GLOVE, POWDER FREE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL (GREEN):
| Chemotherapy Drug | Concentration Average Breakthrough Detection Time (Minutes) |
|---|---|
| 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 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| *Thiotepa (10.0 mg/ml) | 14.7 |
| *Carmustine (BCNU) (3.3 mg/ml) | 11.9 |
| Opioid Drug | Fentanyl Citrate 100 mcg/2mL |
|---|---|
| Breakthrough Detection Time in Minutes | No breakthrough up to 240 minutes |
*WARNING: Testing showed an average breakthrough time of 11.9 minutes for Carmusine and an average breakthrough time of 14.7 minutes for Thiotepa. Do not use with Carmustine and Thiotepa.
NATURAL RUBBER LATEX (STRIP&COAT)/(STRIP&PACK) SURGICAL GLOVE, POWDER FREE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL:
| Chemotherapy Drug | Average Breakthrough Detection Time (Minutes) |
|---|---|
| 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 |
4
| 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 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| *Thiotepa (10.0 mg/ml) | 13.8 |
| *Carmustine (BCNU) (3.3 mg/ml) | 5.7 |
Opioid Drug Fentanyl Citrate 100 mcg/2mL Breakthrough Detection Time in Minutes No breakthrough up to 240 minutes
- WARNING: Testing showed an average breakthrough time of 5.7 minutes for Carmustine and an average breakthrough time of 13.8 minutes for Thiotepa. Do not use with Carmustine and Thiotepa.
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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5
1.0 Submitter:
| Name | : Muhammad Ameer Arief bin Mohd Mujab |
|---|---|
| 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 |
| Date of Summary | |
| Prepared | : 28th March 2024 |
2.0 Identification of the Subject Device:
| Trade Name | : | Natural Rubber Latex Surgical Glove, Powder Free,
Sterile, Tested for Use with Chemotherapy Drugs and
Fentanyl (Green); Natural Rubber Latex
(Strip&Coat)/(Strip&Pack) Surgical Glove, Powder
Free, 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 | Powder-Free Polymer Coated Latex Surgical |
| Gloves, Sterile with Protein Labelling Claim (50 | |
| Micrograms or Less) | |
| 510(k) Number | K020019 |
| Regulatory Class | I |
| Product Code | KGO |
6
4.0 Description of The Device:
This is a disposable natural rubber surgical glove that is tested for use with chemotherapy drugs and fentanyl resistance. The glove is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9.
5.0 Indication for use:
A powder-free sterile surgeon's glove is a disposable device made of natural 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 and Fentanyl Citrate as per ASTM D6978-05 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 | 11.9 |
| 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 | 14.7 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |
5.1 Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green)
7
*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 11.9 minutes and Thiotepa: 14.7. Do not use with Carmustine and Thiotepa.
| Opioid Drug | Concentration | Breakthrough Detection
Time in Minutes |
|----------------------------|---------------|-------------------------------------------|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240
minutes |
5.2 Natural Rubber Latex Surgical Glove (Strip&Coat)/(Strip&Pack), Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
| Chemotherapy Drug | Concentration | Minimum
Breakthrough
Detection Time
(Minutes) |
|----------------------------|---------------|--------------------------------------------------------|
| *Carmustine (BCNU) | 3.3 mg/ml | 5.7 |
| 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 | 13.8 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |
*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 5.7 minutes and Thiotepa: 13.8. Do not use with Carmustine and Thiotepa.
| Opiod Drug | Concentration | Breakthrough Detection
Time in Minutes |
|----------------------------|---------------|-------------------------------------------|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240
minutes |
8
Summary of the Technological Characteristics of the Device: See table 6.0
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
|---|---|---|---|---|
| PREDICATE | CURRENT | |||
| 510(k) Number | ||||
| Manufacturer(s) | - | K020019 | ||
| WRP Asia | ||||
| Pacific Sdn. | ||||
| Bhd. | K232079 | |||
| WRP Asia | ||||
| Pacific Sdn. | ||||
| Bhd. | Same | |||
| Material | ASTM D3577 | Natural Rubber | ||
| Latex | Natural Rubber | |||
| Latex | Same | |||
| Color | - | Natural White | Green and | |
| Natural | Different | |||
| Texture | - | Microroughened | ||
| surface | Microroughened | |||
| surface | Same | |||
| Physical Properties | ASTM D3577 | Meets | Meets | Same |
| Before Aging | ||||
| Tensile Strength: | ||||
| Ultimate Elongation: | ||||
| Stress at 500% | ||||
| Elongation: | Min. 24MPa | |||
| Min. 750% | ||||
| Max. 5.5MPa | ||||
| After Aging | ||||
| Tensile Strength: | ||||
| Ultimate Elongation: | ||||
| Stress at 500% | ||||
| Elongation: | Meets | |||
| Min. 18MPa | ||||
| Min. 560% | ||||
| N/A | Meets | 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 |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE | CURRENT | |
| 510(k) Number
Dimension, Width | ASTM D3577 | K020019
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 | K232079
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 | Passes (Not a primary skin irritant) | Passes (Not a primary skin irritant) | Same |
| | Dermal Sensitization- ISO 10993-10 | Passes (Not a contact sensitizer) | Passes (Not a contact sensitizer) | Same |
| | Acute Systemic Toxicity, ISO 10993-11 | N/A | It is concluded that the devices did not induce any acute systemic toxicity | Different |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE | CURRENT | |
| 510(k) Number | - | K020019 | K232079 | - |
| | Material
Mediated
Pyrogenicity,
ISO 10993-11 | N/A | It is concluded
that the devices
are non-
pyrogenic | Different |
| | Cytotoxicity-
Direct Contact,
ISO 10993-5 | N/A | Non-cytotoxic for
S&C/S&P gloves | Different |
| | Cytotoxicity-
MEM Elution,
ISO 10993-5 | N/A | Under the
conditions of
this study, the
test article
extract showed
potential
toxicity to L929
cells for Green
gloves | Different |
| Watertight (1000ml) | ASTM D5151 | Meets 21 CFR
800.20 and
ASTM D3577
when tested in
accordance
with ASTM
D5151
Inspection
Level I, AQL
0.65 | Meets 21 CFR
800.20 and
ASTM D3577
when tested in
accordance with
ASTM D5151
Inspection Level
I, AQL 0.65 | Same |
| Intended use /
Indications for Use | - | A powder-free
sterile
surgeon's glove
is a disposable
device made of
natural 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. | A powder-free
sterile
surgeon's glove
is a disposable
device made of
natural 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 | Different |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE | CURRENT | |
| 510(k) Number | - | K020019 | K232079 | - |
| | | | Chemotherapy
Drugs and
Fentanyl Citrate
as per ASTM
D6978
Standard
Practice for
Assessment of
Medical Gloves
to Permeation
by
Chemotherapy
Drugs. | |
| 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 | Sterile | Same |
| Sterility Method | ISO 11137-1
ISO 11137-2 | Gamma
Radiation | Gamma
Radiation | Same |
| Chemotherapy Drug
Permeation Test | ASTM D6978-
05 | | | |
| 1. Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy
Drugs and Fentanyl (Green) | | | | |
| * Carmustine (BCNU)
(3.3 mg/ml) | | N/A | 11.9 | Different |
| Cisplatin (1.0 mg/ml) | | N/A | >240 | Different |
| Cyclophosphamide
(Cytoxan) (20.0 mg/ml) | | N/A | >240 | Different |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE | CURRENT | |
| 510(k) Number | - | K020019 | K232079 | - |
| Dacarbazine (10.0 mg/ml) | | N/A | > 240 | Different |
| Doxorubicin
Hydrochloride (2.0 mg/ml) | | N/A | > 240 | Different |
| Etoposide (20.0 mg/ml) | | N/A | > 240 | Different |
| Fluorouracil (50.0 mg/ml) | | N/A | > 240 | Different |
| Ifosfamide (50.0 mg/ml) | | N/A | > 240 | Different |
| Methotrexate (25.0 mg/ml) | | N/A | > 240 | Different |
| Mitomycin C (0.5 mg/ml) | | N/A | > 240 | Different |
| Mitoxantrone (2.0 mg/ml) | | N/A | > 240 | Different |
| Paclitaxel (6.0 mg/ml) | | N/A | > 240 | Different |
| * ThioTepa (10.0 mg/ml) | | N/A | 14.7 | Different |
| Vincristine Sulfate (1.0 mg/ml) | | N/A | > 240 | Different |
| Warning Statement | | N/A | *WARNING:
Please note the
following drugs
have extremely
low permeation
times:
Carmustine
(BCNU): 11.9
minutes and
Thiotepa: 14.7
minutes. Do not
use with
Carmustine and
Thiotepa. | Different |
| Fentanyl Citrate (100 mcg/2mL) | ASTM D6978-
05 | N/A | > 240 | Different |
| 2. Natural Rubber Latex Surgical Glove (Strip&Coat)/(Strip&Pack), Powder Free, Sterile, Tested
for Use with Chemotherapy Drugs and Fentanyl | | | | |
| * Carmustine (BCNU)
(3.3 mg/ml) | | N/A | 5.7 | Different |
| Cisplatin (1.0 mg/ml) | | N/A | >240 | Different |
| Characteristics | | PREDICATE | CURRENT | Comparison |
| 510(k) Number | | K020019 | K232079 | |
| Cyclophosphamide
(Cytoxan) (20.0
mg/ml) | | N/A | >240 | Different |
| Dacarbazine (10.0
mg/ml) | | N/A | > 240 | Different |
| Doxorubicin
Hydrochloride (2.0
mg/ml) | | N/A | > 240 | Different |
| Etoposide (20.0
mg/ml) | | N/A | > 240 | Different |
| Fluorouracil (50.0
mg/ml) | | N/A | > 240 | Different |
| Ifosfamide (50.0
mg/ml) | | N/A | > 240 | Different |
| Methotrexate (25.0
mg/ml) | | N/A | > 240 | Different |
| Mitomycin C (0.5
mg/ml) | | N/A | > 240 | Different |
| Mitoxantrone (2.0
mg/ml) | | N/A | > 240 | Different |
| Paclitaxel (6.0 mg/ml) | | N/A | > 240 | Different |
| * ThioTepa (10.0
mg/ml) | | N/A | 13.8 | Different |
| Vincristine Sulfate (1.0
mg/ml) | | N/A | > 240 | Different |
| Warning Statement | | N/A | *WARNING:
Please note the
following drugs
have extremely
low permeation
times:
Carmustine
(BCNU): 5.7
minutes and
Thiotepa: 13.8
minutes. Do not
use with
Carmustine and
Thiotepa. | Different |
| Fentanyl Citrate (100
mcg/2mL) | ASTM D6978-
05 | N/A | > 240 | Different |
9
10
11
12
13
14
510(k) SUMMARY
7.0 Summary of Non-Clinical Testing
| 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 | Tensile
strength | Before
Aging
Min.
24MPa
After
Aging
Min.
18MPa | Before
Aging
Pass | After
Aging
Pass |
| | | | Ultimate
elongation | Min.
750%
Min.
560% | Pass | Pass |
| | | | Stress at
500%
Elongation | Max.
5.5MPa
N/A | Pass | N/A |
| 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 | Finger - Min. 0.10 mm
Palm - Min. 0.10 mm
Cuff - Min. 0.10 mm | Pass | |
| Watertight | ASTM D5151
(Standard Test
Method for
Detection of
Holes in
Medical
Gloves) | To measure
glove integrity | Freedom from holes at AQL 0.65 | | Pass | |
| Residual
Powder | ASTM D6124
(Standard Test
Method for
Residual
Powder on
Medical
Gloves) | To determine the
amount of
residual powder
and non-powder
solids found on
gloves | Have a powder residue limit of
2.0 mg per glove | | Pass | |
| Protein
Content | ASTM D5712
(Test Method for
Analysis of
Aqueous
Extractable
Protein in Latex,
Natural Rubber,
and Elastomeric
Products
Using the
Modified Lowry
Method) | To determine the
amount of
extractable
protein from the
glove | ≤ 200 µg/dm2 | | Pass | |
15
510(k) SUMMARY
| Test Method | Standard | Purpose of Testing | Result Summary |
|---|---|---|---|
| Biocompatibility | Primary Skin Irritation - | ||
| ISO 10993-10 | To assess the | ||
| potential of glove to | |||
| produce dermal | |||
| irritation | Not a primary skin irritation | ||
| Biocompatibility | Dermal Sensitization- | ||
| ISO 10993-10 | To assess the | ||
| potential of glove to | |||
| cause a delayed | |||
| hypersensitivity | |||
| (Type IV) | |||
| immunological | |||
| response | Not a contact sensitizer | ||
| Biocompatibility | Acute Systemic Toxicity, | ||
| ISO 10993-11 | To determine the | ||
| acute systemic | |||
| toxicity potential of | |||
| glove | No biological reactivity shown | ||
| Biocompatibility | Material Mediated | ||
| Pyrogenicity, ISO | |||
| 10993-11 | To determine any | ||
| pyrogenic response | |||
| induced by the glove | No increase of temperature | ||
| Biocompatibility | Cytotoxicity- Direct | ||
| Contact, ISO 10993-5 | To determine the | ||
| cytotoxicity potential | |||
| of glove | Non-cytotoxic for S&C/S&P gloves | ||
| Biocompatibility | Cytotoxicity- MEM | ||
| Elution, ISO 10993-5 | To determine the | ||
| cytotoxicity potential | |||
| of glove | Under the conditions of this | ||
| study, the test article extract | |||
| showed potential toxicity to L929 | |||
| cells for Natural Rubber Latex | |||
| Green | |||
| Bacterial | |||
| endotoxin | Limulus Amoebocyte | ||
| Lysate (LAL) test | To determine the | ||
| amount of endotoxin | |||
| on the glove | ≤20 EU/pair of gloves |
8.0 Summary of Clinical Testing:
No clinical study is included in this submission.
9.0 Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the subject devices Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) and Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl are as safe, effective, and perform as well as or better than the legally marketed predicate device K020019.