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

K232079 · Wrp Asia Pacific Sdn. Bhd. · KGO · Mar 28, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K232079
• 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
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Mar 28, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended 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.

Device Story

Disposable natural rubber latex surgical gloves; sterile; powder-free. Used by healthcare personnel in clinical settings as a barrier against cross-contamination. Tested for permeation resistance against specific chemotherapy drugs and fentanyl citrate per ASTM D6978-05. Output is a physical barrier worn on hands. Provides protection during handling of hazardous drugs; however, specific drugs (Carmustine and Thiotepa) show low permeation times and are contraindicated for use with these gloves. Device performance verified through bench testing for physical properties, biocompatibility, and chemical permeation.

Clinical Evidence

No clinical data. Bench testing only. Testing included physical properties (ASTM D412), dimensions (ASTM D3767), watertight integrity (ASTM D5151), residual powder (ASTM D6124), protein content (ASTM D5712), biocompatibility (ISO 10993-5, -10, -11), and chemotherapy/fentanyl permeation (ASTM D6978-05).

Technological Characteristics

Natural rubber latex; microroughened surface; sterile (gamma radiation). Complies with ASTM D3577 (physical properties), ASTM D6124 (powder-free), and ASTM D6978-05 (chemotherapy permeation). Biocompatibility per ISO 10993. Sizes 5.5-9.0.

Indications for Use

Indicated for use by healthcare personnel as a protective barrier against cross-contamination between personnel and patients. Tested for use with specific chemotherapy drugs and fentanyl citrate.

Regulatory Classification

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.

Predicate Devices

• Powder-Free Polymer Coated Latex Surgical Gloves, Sterile with Protein Labelling Claim (50 Micrograms or Less) (K020019)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak<br>Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No. | : [phone] |
| Fax No. | : [phone] |
| Date of Summary<br>Prepared | : 28th March 2024 |

#### 2.0 Identification of the Subject Device:

| Trade Name | : | Natural Rubber Latex Surgical Glove, Powder Free,<br>Sterile, Tested for Use with Chemotherapy Drugs and<br>Fentanyl (Green); Natural Rubber Latex<br>(Strip&Coat)/(Strip&Pack) Surgical Glove, Powder<br>Free, Sterile, Tested for Use with Chemotherapy<br>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<br>Gloves, Sterile with Protein Labelling Claim (50<br>Micrograms or Less) |
| 510(k) Number | K020019 |
| Regulatory Class | I |
| Product Code | KGO |

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#### 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<br>Breakthrough<br>Detection Time<br>(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)

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*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<br>Time in Minutes |
|----------------------------|---------------|-------------------------------------------|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240<br>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<br>Breakthrough<br>Detection Time<br>(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<br>Time in Minutes |
|----------------------------|---------------|-------------------------------------------|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240<br>minutes |

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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) Number<br>Manufacturer(s) | - | K020019<br>WRP Asia<br>Pacific Sdn.<br>Bhd. | K232079<br>WRP Asia<br>Pacific Sdn.<br>Bhd. | Same |
| Material | ASTM D3577 | Natural Rubber<br>Latex | Natural Rubber<br>Latex | Same |
| Color | - | Natural White | Green and<br>Natural | Different |
| Texture | - | Microroughened<br>surface | Microroughened<br>surface | Same |
| Physical Properties | ASTM D3577 | Meets | Meets | Same |
| Before Aging<br>Tensile Strength:<br>Ultimate Elongation:<br>Stress at 500%<br>Elongation: | | Min. 24MPa<br>Min. 750%<br>Max. 5.5MPa | | |
| After Aging<br>Tensile Strength:<br>Ultimate Elongation:<br>Stress at 500%<br>Elongation: | | Meets<br>Min. 18MPa<br>Min. 560%<br>N/A | Meets | Same |
| Thickness:<br>- Finger<br>- Palm<br>- Cuff | ASTM D3577 | Meets<br>Min. 0.10 mm<br>Min. 0.10 mm<br>Min. 0.10 mm | Meets<br>Min. 0.10 mm<br>Min. 0.10 mm<br>Min. 0.10 mm | Same |
| Dimension, Length | ASTM D3577 | Meets<br>5½: Min.<br>245mm<br>6.0: Min. 265<br>mm<br>6½: Min. 265<br>mm<br>7.0: Min. 265<br>mm<br>7½: Min. 265<br>mm<br>8.0: Min. 265<br>mm<br>8½: Min. 265<br>mm<br>9.0: Min. 265<br>mm | Meets<br>5½: Min.<br>245mm<br>6.0: Min. 265<br>mm<br>6½: Min. 265<br>mm<br>7.0: Min. 265<br>mm<br>7½: Min. 265<br>mm<br>8.0: Min. 265<br>mm<br>8½: Min. 265<br>mm<br>9.0: Min. 265<br>mm | Same |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE | CURRENT | |
| 510(k) Number<br>Dimension, Width | ASTM D3577 | K020019<br>Meets<br>5½: 70 ± 6 mm<br>6.0: 76 ± 6 mm<br>6½: 83 ± 6 mm<br>7.0: 89 ± 6 mm<br>7½: 95 ± 6 mm<br>8.0: 102 ± 6 mm<br>8½: 108 ± 6 mm<br>9.0: 114 ± 6 mm | K232079<br>Meets<br>5½: 70 ± 6 mm<br>6.0: 76 ± 6 mm<br>6½: 83 ± 6 mm<br>7.0: 89 ± 6 mm<br>7½: 95 ± 6 mm<br>8.0: 102 ± 6 mm<br>8½: 108 ± 6 mm<br>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<br>Mediated<br>Pyrogenicity,<br>ISO 10993-11 | N/A | It is concluded<br>that the devices<br>are non-<br>pyrogenic | Different |
| | Cytotoxicity-<br>Direct Contact,<br>ISO 10993-5 | N/A | Non-cytotoxic for<br>S&C/S&P gloves | Different |
| | Cytotoxicity-<br>MEM Elution,<br>ISO 10993-5 | N/A | Under the<br>conditions of<br>this study, the<br>test article<br>extract showed<br>potential<br>toxicity to L929<br>cells for Green<br>gloves | Different |
| Watertight (1000ml) | ASTM D5151 | Meets 21 CFR<br>800.20 and<br>ASTM D3577<br>when tested in<br>accordance<br>with ASTM<br>D5151<br>Inspection<br>Level I, AQL<br>0.65 | Meets 21 CFR<br>800.20 and<br>ASTM D3577<br>when tested in<br>accordance with<br>ASTM D5151<br>Inspection Level<br>I, AQL 0.65 | Same |
| Intended use /<br>Indications for Use | - | A powder-free<br>sterile<br>surgeon's glove<br>is a disposable<br>device made of<br>natural rubber<br>intended to be<br>worn on the<br>hands of<br>healthcare<br>personnel as a<br>barrier for<br>protection<br>against cross-<br>contamination<br>between the<br>healthcare<br>personnel and<br>patient. | A powder-free<br>sterile<br>surgeon's glove<br>is a disposable<br>device made of<br>natural rubber<br>intended to be<br>worn on the<br>hands of<br>healthcare<br>personnel as a<br>barrier for<br>protection<br>against cross-<br>contamination<br>between the<br>healthcare<br>personnel and<br>patient.<br>These gloves<br>were tested for | Different |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE | CURRENT | |
| 510(k) Number | - | K020019 | K232079 | - |
| | | | Chemotherapy<br>Drugs and<br>Fentanyl Citrate<br>as per ASTM<br>D6978<br>Standard<br>Practice for<br>Assessment of<br>Medical Gloves<br>to Permeation<br>by<br>Chemotherapy<br>Drugs. | |
| Size | Medical Glove<br>Guidance<br>Manual -<br>Labeling | 5½<br>6.0<br>6½<br>7.0<br>7½<br>8.0<br>8½<br>9.0 | 5½<br>6.0<br>6½<br>7.0<br>7½<br>8.0<br>8½<br>9.0 | Same |
| Single Use | Medical Glove<br>Guidance<br>Manual -<br>Labeling | Single use | Single use | Same |
| Sterility Status | Medical Glove<br>Guidance<br>Manual -<br>Labeling | Sterile | Sterile | Same |
| Sterility Method | ISO 11137-1<br>ISO 11137-2 | Gamma<br>Radiation | Gamma<br>Radiation | Same |
| Chemotherapy Drug<br>Permeation Test | ASTM D6978-<br>05 | | | |
| 1. Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy<br>Drugs and Fentanyl (Green) | | | | |
| * Carmustine (BCNU)<br>(3.3 mg/ml) | | N/A | 11.9 | Different |
| Cisplatin (1.0 mg/ml) | | N/A | >240 | Different |
| Cyclophosphamide<br>(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<br>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:<br>Please note the<br>following drugs<br>have extremely<br>low permeation<br>times:<br>Carmustine<br>(BCNU): 11.9<br>minutes and<br>Thiotepa: 14.7<br>minutes. Do not<br>use with<br>Carmustine and<br>Thiotepa. | Different |
| Fentanyl Citrate (100 mcg/2mL) | ASTM D6978-<br>05 | N/A | > 240 | Different |
| 2. Natural Rubber Latex Surgical Glove (Strip&Coat)/(Strip&Pack), Powder Free, Sterile, Tested<br>for Use with Chemotherapy Drugs and Fentanyl | | | | |
| * Carmustine (BCNU)<br>(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<br>(Cytoxan) (20.0<br>mg/ml) | | N/A | >240 | Different |
| Dacarbazine (10.0<br>mg/ml) | | N/A | > 240 | Different |
| Doxorubicin<br>Hydrochloride (2.0<br>mg/ml) | | N/A | > 240 | Different |
| Etoposide (20.0<br>mg/ml) | | N/A | > 240 | Different |
| Fluorouracil (50.0<br>mg/ml) | | N/A | > 240 | Different |
| Ifosfamide (50.0<br>mg/ml) | | N/A | > 240 | Different |
| Methotrexate (25.0<br>mg/ml) | | N/A | > 240…