(259 days)
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.
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.
The provided document describes the acceptance criteria and study results for two types of Natural Rubber Latex Surgical Gloves:
- 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
This is a 510(k) Premarket Notification submission, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. The information provided focuses on the performance of the device against established standards (e.g., ASTM standards) rather than a clinical trial with human subjects or an AI-based study. As such, many of the requested points related to AI/MRMC studies, expert ground truth establishment, adjudication methods, and training/test set sample sizes for AI are not applicable to this type of device submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The "Summary of Non-Clinical Testing" (pages 15-16) and "Table 1" (pages 8-14) present the acceptance criteria and the device's performance.
Summary Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test Method | Standard(s) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties | ASTM D412 | ||
| Tensile Strength | - | Before Aging: Min. 24MPa; After Aging: Min. 18MPa | Before Aging: Pass; After Aging: Pass |
| Ultimate Elongation | - | Before Aging: Min. 750%; After Aging: Min. 560% | Before Aging: Pass; After Aging: Pass |
| Stress at 500% Elongation | - | Before Aging: Max. 5.5MPa; After Aging: N/A | Before Aging: Pass; After Aging: N/A |
| Dimension | ASTM D3767 | ||
| Length | Each size satisfies ASTM requirement | Length: Each size satisfies ASTM requirement | Pass (5½: Min. 245mm; 6.0-9.0: Min. 265mm for both devices) |
| Width | Each size satisfies ASTM requirement | Width: Each size satisfies ASTM requirement | Pass (e.g., 5½: 70 ± 6 mm; 9.0: 114 ± 6 mm for both devices) |
| Thickness | - | Finger: Min. 0.10 mm; Palm: Min. 0.10 mm; Cuff: Min. 0.10 mm | Pass |
| Watertight | ASTM D5151 | Freedom from holes at AQL 0.65 | Pass (Meets 21 CFR 800.20 and ASTM D3577 when tested in accordance with ASTM D5151 Inspection Level I, AQL 0.65) |
| Residual Powder | ASTM D6124 | Powder residue limit of ≤2.0 mg per glove | Pass |
| Protein Content | ASTM D5712 | ≤ 200 µg/dm2 | Pass |
| Biocompatibility | |||
| Primary Skin Irritation | ISO 10993-10 | Not a primary skin irritant | Not a primary skin irritation (Passes) |
| Dermal Sensitization | ISO 10993-10 | Not a contact sensitizer | Not a contact sensitizer (Passes) |
| Acute Systemic Toxicity | ISO 10993-11 | No biological reactivity shown | No biological reactivity shown (It is concluded that the devices did not induce any acute systemic toxicity) |
| Material Mediated Pyrogenicity | ISO 10993-11 | No increase of temperature (Non-pyrogenic) | No increase of temperature (It is concluded that the devices are non-pyrogenic) |
| Cytotoxicity - Direct Contact | ISO 10993-5 | Non-cytotoxic | Non-cytotoxic for S&C/S&P gloves |
| Cytotoxicity - MEM Elution | ISO 10993-5 | Non-cytotoxic | For Green gloves: Under the conditions of this study, the test article extract showed potential toxicity to L929 cells. For Strip&Coat/Strip&Pack gloves: Non-cytotoxic for S&C/S&P gloves (Note: This is a discrepancy with the table on page 16, which only shows the Green glove result for MEM Elution. However, the final conclusion states non-cytotoxic for S&C/S&P gloves in the direct contact test, implying potential difference in test methods or interpretation for the two types of gloves). |
| Bacterial Endotoxin | Limulus Amoebocyte Lysate (LAL) test | ≤20 EU/pair of gloves | Pass |
| Chemotherapy Drug Permeation | ASTM D6978-05 | Breakthrough Detection Time in Minutes: Generally >240 minutes | Green Glove: Most drugs >240 min. Exceptions: Carmustine (11.9 min), Thiotepa (14.7 min). Strip&Coat/Strip&Pack Glove: Most drugs >240 min. Exceptions: Carmustine (5.7 min), Thiotepa (13.8 min). WARNING labels are provided for Carmustine and Thiotepa. |
| Fentanyl Citrate Permeation | ASTM D6978-05 | Breakthrough Detection Time in Minutes: No breakthrough up to 240 minutes | No breakthrough up to 240 minutes (for both glove types). |
| Sterility Status | Medical Glove Guidance Manual - Labeling | Sterile | Sterile |
| Sterility Method | ISO 11137-1, ISO 11137-2 | Gamma Radiation (effective) | Gamma Radiation (Same as predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the specific number of gloves (sample size) used for each physical, chemical, and biocompatibility test. It refers to compliance with ASTM standards, which typically specify minimum sample sizes for testing (e.g., ASTM D5151 for watertightness requires a specific inspection level and AQL, implying a certain sample size based on lot size). However, the exact sample numbers are not itemized here.
- Data Provenance: The tests are non-clinical (laboratory tests) performed on the manufactured gloves. The manufacturer is WRP Asia Pacific Sdn. Bhd., located in Malaysia (as per Section 1.0 Submitter). The data is generated from testing of the finished device. It is inherently "prospective" in the sense that the tests were conducted specifically for this submission, validating the device's properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a medical device submission based on a laboratory evaluation against recognized performance standards (ASTM, ISO, CFR). The "ground truth" for the device's physical and chemical properties is established by these objective, standardized test methods and their defined acceptance criteria, not by human expert interpretation or consensus as would be the case for an AI-enabled diagnostic device.
4. Adjudication Method for the Test Set
- Not Applicable. As the tests are objective, laboratory-based measurements (e.g., tensile strength, breakthrough time, watertightness), there is no need for expert adjudication. The results are quantitative and compared directly to predetermined numerical acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI assistance on that interpretation. This submission is for a physical barrier device (surgical gloves), not an AI-enabled diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
- Ground Truth: The ground truth for this device is established by objective, standardized test methods and their defined acceptance criteria. These standards (e.g., ASTM D3577, ASTM D6978-05, ISO 10993 series) specify a methodology for testing and a quantitative or qualitative result that the device must meet (e.g., minimum tensile strength, maximum protein content, no breakthrough of chemicals). The chemical permeation results are based on the ASTM D6978-05 standard for chemotherapy drug permeation.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The glove is a manufactured product whose performance is evaluated against material and safety standards.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. Since there is no training set, this question is not relevant.
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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.
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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
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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
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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 |
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| 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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1.0 Submitter:
| Name | : Muhammad Ameer Arief bin Mohd Mujab |
|---|---|
| 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 |
| Date of SummaryPrepared | : 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 andFentanyl (Green); Natural Rubber Latex(Strip&Coat)/(Strip&Pack) Surgical Glove, PowderFree, Sterile, Tested for Use with ChemotherapyDrugs 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 SurgicalGloves, Sterile with Protein Labelling Claim (50Micrograms 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 | MinimumBreakthroughDetection 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 DetectionTime in Minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240minutes |
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 | MinimumBreakthroughDetection 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 DetectionTime in Minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240minutes |
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Summary of the Technological Characteristics of the Device: See table 6.0
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
|---|---|---|---|---|
| PREDICATE | CURRENT | |||
| 510(k) NumberManufacturer(s) | - | K020019WRP AsiaPacific Sdn.Bhd. | K232079WRP AsiaPacific Sdn.Bhd. | Same |
| Material | ASTM D3577 | Natural RubberLatex | Natural RubberLatex | Same |
| Color | - | Natural White | Green andNatural | Different |
| Texture | - | Microroughenedsurface | Microroughenedsurface | Same |
| Physical Properties | ASTM D3577 | Meets | Meets | Same |
| Before AgingTensile Strength:Ultimate Elongation:Stress at 500%Elongation: | Min. 24MPaMin. 750%Max. 5.5MPa | |||
| After AgingTensile Strength:Ultimate Elongation:Stress at 500%Elongation: | MeetsMin. 18MPaMin. 560%N/A | Meets | 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.245mm6.0: Min. 265mm6½: Min. 265mm7.0: Min. 265mm7½: Min. 265mm8.0: Min. 265mm8½: Min. 265mm9.0: Min. 265mm | Meets5½: Min.245mm6.0: Min. 265mm6½: Min. 265mm7.0: Min. 265mm7½: Min. 265mm8.0: Min. 265mm8½: Min. 265mm9.0: Min. 265mm | Same |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
| PREDICATE | CURRENT | |||
| 510(k) NumberDimension, Width | ASTM D3577 | K020019Meets5½: 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 | K232079Meets5½: 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 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 | - |
| MaterialMediatedPyrogenicity,ISO 10993-11 | N/A | It is concludedthat the devicesare non-pyrogenic | Different | |
| Cytotoxicity-Direct Contact,ISO 10993-5 | N/A | Non-cytotoxic forS&C/S&P gloves | Different | |
| Cytotoxicity-MEM Elution,ISO 10993-5 | N/A | Under theconditions ofthis study, thetest articleextract showedpotentialtoxicity to L929cells for Greengloves | Different | |
| Watertight (1000ml) | ASTM D5151 | Meets 21 CFR800.20 andASTM D3577when tested inaccordancewith ASTMD5151InspectionLevel I, AQL0.65 | Meets 21 CFR800.20 andASTM D3577when tested inaccordance withASTM D5151Inspection LevelI, AQL 0.65 | Same |
| Intended use /Indications for Use | - | A powder-freesterilesurgeon's gloveis a disposabledevice made ofnatural rubberintended to beworn on thehands ofhealthcarepersonnel as abarrier forprotectionagainst cross-contaminationbetween thehealthcarepersonnel andpatient. | A powder-freesterilesurgeon's gloveis a disposabledevice made ofnatural rubberintended to beworn on thehands ofhealthcarepersonnel as abarrier forprotectionagainst cross-contaminationbetween thehealthcarepersonnel andpatient.These gloveswere tested for | Different |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | COMPARISON ANALYSIS | |
| PREDICATE | CURRENT | |||
| 510(k) Number | - | K020019 | K232079 | - |
| ChemotherapyDrugs andFentanyl Citrateas per ASTMD6978StandardPractice forAssessment ofMedical Glovesto PermeationbyChemotherapyDrugs. | ||||
| 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 GloveGuidanceManual -Labeling | Sterile | Sterile | Same |
| Sterility Method | ISO 11137-1ISO 11137-2 | GammaRadiation | GammaRadiation | Same |
| Chemotherapy DrugPermeation Test | ASTM D6978-05 | |||
| 1. Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with ChemotherapyDrugs 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 | |
| DoxorubicinHydrochloride (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 thefollowing drugshave extremelylow permeationtimes:Carmustine(BCNU): 11.9minutes andThiotepa: 14.7minutes. Do notuse withCarmustine andThiotepa. | 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, Testedfor 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) (20.0mg/ml) | N/A | >240 | Different | |
| Dacarbazine (10.0mg/ml) | N/A | > 240 | Different | |
| DoxorubicinHydrochloride (2.0mg/ml) | N/A | > 240 | Different | |
| Etoposide (20.0mg/ml) | N/A | > 240 | Different | |
| Fluorouracil (50.0mg/ml) | N/A | > 240 | Different | |
| Ifosfamide (50.0mg/ml) | N/A | > 240 | Different | |
| Methotrexate (25.0mg/ml) | N/A | > 240 | Different | |
| Mitomycin C (0.5mg/ml) | N/A | > 240 | Different | |
| Mitoxantrone (2.0mg/ml) | N/A | > 240 | Different | |
| Paclitaxel (6.0 mg/ml) | N/A | > 240 | Different | |
| * ThioTepa (10.0mg/ml) | N/A | 13.8 | Different | |
| Vincristine Sulfate (1.0mg/ml) | N/A | > 240 | Different | |
| Warning Statement | N/A | *WARNING:Please note thefollowing drugshave extremelylow permeationtimes:Carmustine(BCNU): 5.7minutes andThiotepa: 13.8minutes. Do notuse withCarmustine andThiotepa. | Different | |
| Fentanyl Citrate (100mcg/2mL) | ASTM D6978-05 | N/A | > 240 | Different |
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510(k) SUMMARY
7.0 Summary of Non-Clinical Testing
| TestMethod | Standard | Purpose ofTesting | Acceptance Criteria | Results | ||
|---|---|---|---|---|---|---|
| PhysicalProperties | ASTM D412(Standard TestMethod forVulcanizedRubber andThermoplasticElastomers -Tension) | To evaluate thetensile (tension)properties ofglove | Tensilestrength | BeforeAgingMin.24MPaAfterAgingMin.18MPa | BeforeAgingPass | AfterAgingPass |
| Ultimateelongation | Min.750%Min.560% | Pass | Pass | |||
| Stress at500%Elongation | Max.5.5MPaN/A | Pass | N/A | |||
| Dimension | ASTM D3767(StandardPractice forRubber -Measurementof Dimensions) | To measure thelength, width andthickness ofglove | Length: Each size satisfies ASTM requirementWidth: Each size satisfies ASTM requirement | Pass | ||
| Dimension | ASTM D3767(StandardPractice forRubber -Measurementof Dimensions) | To measure thelength, width andthickness ofglove | Thickness | Finger - Min. 0.10 mmPalm - Min. 0.10 mmCuff - Min. 0.10 mm | Pass | |
| Watertight | ASTM D5151(Standard TestMethod forDetection ofHoles inMedicalGloves) | To measureglove integrity | Freedom from holes at AQL 0.65 | Pass | ||
| ResidualPowder | ASTM D6124(Standard TestMethod forResidualPowder onMedicalGloves) | To determine theamount ofresidual powderand non-powdersolids found ongloves | Have a powder residue limit of2.0 mg per glove | Pass | ||
| ProteinContent | ASTM D5712(Test Method forAnalysis ofAqueousExtractableProtein in Latex,Natural Rubber,and ElastomericProductsUsing theModified LowryMethod) | To determine theamount ofextractableprotein from theglove | ≤ 200 µg/dm2 | Pass |
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510(k) SUMMARY
| Test Method | Standard | Purpose of Testing | Result Summary |
|---|---|---|---|
| Biocompatibility | Primary Skin Irritation -ISO 10993-10 | To assess thepotential of glove toproduce dermalirritation | Not a primary skin irritation |
| Biocompatibility | Dermal Sensitization-ISO 10993-10 | To assess thepotential of glove tocause a delayedhypersensitivity(Type IV)immunologicalresponse | Not a contact sensitizer |
| Biocompatibility | Acute Systemic Toxicity,ISO 10993-11 | To determine theacute systemictoxicity potential ofglove | No biological reactivity shown |
| Biocompatibility | Material MediatedPyrogenicity, ISO10993-11 | To determine anypyrogenic responseinduced by the glove | No increase of temperature |
| Biocompatibility | Cytotoxicity- DirectContact, ISO 10993-5 | To determine thecytotoxicity potentialof glove | Non-cytotoxic for S&C/S&P gloves |
| Biocompatibility | Cytotoxicity- MEMElution, ISO 10993-5 | To determine thecytotoxicity potentialof glove | Under the conditions of thisstudy, the test article extractshowed potential toxicity to L929cells for Natural Rubber LatexGreen |
| Bacterialendotoxin | Limulus AmoebocyteLysate (LAL) test | To determine theamount of endotoxinon 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.
§ 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).