Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl

K230578 · Wrp Asia Pacific Sdn. Bhd. · KGO · Aug 31, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230578
• Device Name: Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Aug 31, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Indications for Use

A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following chemicals have been tested with these gloves. [Table of drugs and breakthrough times] *WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 67.6 minutes and Thiotepa: 77.7. Do not use with Carmustine and Thiotepa. Fentanyl Fentanyl Citrate Injection 100mcg/2mL No breakthrough up to 240 minutes

Device Story

Disposable polyisoprene surgical glove; two-layer construction (white outer, green inner); layers attached at cuff; unattached in fingers/palm. Used by healthcare personnel in clinical settings as barrier protection. Tested for permeation resistance against chemotherapy drugs and fentanyl per ASTM D6978. Provides physical barrier; protects personnel from patient contaminants and exposure to hazardous drugs. Supplied sterile in various sizes.

Clinical Evidence

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

Technological Characteristics

Material: Polyisoprene rubber (ASTM D3577). Form: Double-layer sterile surgical glove. Sterilization: Gamma radiation (ISO 11137). Texture: Bisque finish. Connectivity: None. Software: None.

Indications for Use

Indicated for healthcare personnel as a sterile, disposable barrier to prevent cross-contamination between personnel and patients. Tested for use with specific chemotherapy drugs and fentanyl.

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

• Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance (K222058)

Submission Summary (Full Text)

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August 31, 2023

WRP Asia Pacific Sdn. Bhd. % Michael Scaglione U.S. Agent WRP USA Inc 3700 Massillon Road, Suite 340 Uniontown, Ohio 44685

Re: K230578

Trade/Device Name: Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I. reserved Product Code: KGO, LZC, OPJ, QDO Dated: July 24, 2023 Received: August 1, 2023

Dear Michael Scaglione:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Bifeng Qian -S

BiFeng Oian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

### 510(k) Number (if known) K230578

### Device Name

Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl

### Indications for Use (Describe)

A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Chemotherapy Drug Permeation The following chemicals have been tested with these gloves.

| Chemotherapy Drug (Concentration) | Minimum Breakthrough Detection Time (Minutes) |
|-----------------------------------------|-----------------------------------------------|
| *Carmustine (BCNU) (3.3 mg/ml) | 67.6 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| *Thiotepa (10.0 mg/ml) | 77.7 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |

*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 67.6 minutes and Thiotepa: 77.7. Do not use with Carmustine and Thiotepa.

| Fentanyl | | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Fentanyl Citrate Injection | 100mcg/2mL | No breakthrough up to 240 minutes |
| Type of Use (Select one or both, as applicable) | | |
| | <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | |

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### Date of Preparation: August 31, 2023

#### 1.0 Submitter:

| Name | : Saravanan Ramasamy |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------|
| 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] |

#### 2.0 Identification of the Subject Device:

| Trade Name | : | Polyisoprene Surgical Glove (Unified Double Layer),<br>Sterile, Tested for Use with Chemotherapy Drugs and<br>Fentanyl |
|-----------------------|---|------------------------------------------------------------------------------------------------------------------------|
| Common Name | : | Surgical Gloves |
| Classification Name | : | Non-powdered Surgeon's Glove |
| Device Classification | : | I |
| Regulation Number | : | 21 CFR 878.4460 |
| Product Code | : | KGO, LZC, OPJ, QDO |

#### 3.0 Predicate Device:

| | Predicate |
|------------------|-------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | WRP Asia Pacific Sdn. Bhd. |
| Device name | Polyisoprene Surgical Glove, Powder Free,<br>Sterile, Tested for Use with Chemotherapy Drugs<br>and Fentanyl Resistance |
| 510(k) Number | K222058 |
| Regulatory Class | I |
| Product Code | KGO, LZC, OPJ |

#### 4.0 Description of The Device:

This is a disposable polyisoprene surqical glove that is tested for use with chemotherapy drugs and fentanyl. The device is composed of two layers which are not attached in the fingers or palm/back of hand region, but are attached in the cuff area. The outer layer of the glove is white and the inner layer is green. The glove is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 81/2 and 9, and is provided sterile. No shelf life is claimed.

#### 5.0 Indication for use:

A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier

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for protection against cross-contamination between the healthcare personnel and patient.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

### Chemotherapy Drug Permeation

The following chemicals have been tested with these gloves.

| Chemotherapy Drug | Concentration | Minimum<br>Breakthrough<br>Detection Time<br>(Minutes) |
|----------------------------|---------------|--------------------------------------------------------|
| *Carmustine (BCNU) | 3.3 mg/ml | 67.6 |
| Cisplatin | 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Ifosfamide | 50.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |
| Mitoxantrone | 2.0 mg/ml | > 240 |
| Paclitaxel | 6.0 mg/ml | > 240 |
| *Thiotepa | 10.0 mg/ml | 77.7 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |

*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 67.6 minutes and Thiotepa: 77.7. Do not use with Carmustine and Thiotepa.

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

#### 6.0 Summary of the Technological Characteristics of the Device: See table

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### Table 1

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | PREDICATE<br>K222058 | CURRENT<br>K230578 | COMPARISON<br>ANALYSIS | | | | | |
|-----------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--|---------|
| 510(k) Number | - | | | | | | | | | |
| Manufacturer(s) | - | | WRP Asia Pacific Sdn. Bhd. | WRP Asia Pacific Sdn. Bhd. | Same | | | | | |
| Material | ASTM D3577 | | Polyisoprene Rubber | Polyisoprene Rubber | Same | | | | | |
| Color | - | | Natural White | Green and White | Different | | | | | |
| Texture | - | | Bisque Finish | Bisque Finish | Same | | | | | |
| Physical Properties | ASTM D3577 | | Meets | Meets | Same | | | | | |
| Before Aging<br>Tensile Strength:<br>Ultimate<br>Elongation: Stress<br>at 500%<br>Elongation: | | | Min. 17MPa Min. 650%<br><br>Max. 7.0MPa | Min. 17MPa Min. 650%<br><br>Max. 7.0MPa | | | | | | |
| After Aging Tensile<br>Strength: Ultimate<br>Elongation: Stress<br>at 500%<br>Elongation: | | | Meets<br>Min. 12MPa Min. 490%<br><br>N/A | Meets<br>Min. 12MPa Min. 490%<br><br>N/A | Same | | | | | |
| Thickness:<br>- Finger<br>- Palm<br>- Cuff | ASTM D3577 | | Meets<br><br>Min. 0.10 mm<br>Min. 0.10 mm<br>Min. 0.10 mm | Meets<br><br>Min. 0.10 mm<br>Min. 0.10 mm<br>Min. 0.10 mm | Same | | | | | |
| Dimension, Length | ASTM D3577 | | Meets<br><br>5½: Min. 245mm 6.0: Min. 265 mm 6½: Min. 265 mm<br>7.0: Min. 265 mm 7½: Min. 265 mm 8.0: Min. 265 mm<br>8½: Min. 265 mm<br>9.0: Min. 265 mm | Meets<br><br>5½: Min. 245mm 6.0: Min. 265 mm 6½: Min. 265 mm 7.0: Min. 265 mm<br>7½: Min. 265 mm 8.0: Min. 265 mm 8½: Min. 265 mm<br>9.0: Min. 265 mm | Same | | | | | |
| Dimension, Width | ASTM D3577 | | Meets<br><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 | Meets<br><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<br>Irritation - ISO<br>10993-10 (E) | | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant | Same | | | | | |
| | Dermal<br>Sensitization-<br>ISO 10993-10<br>(E) | | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Same | | | | | |
| | Acute Systemic<br>Toxicity, ISO<br>10993-11 (E) | | Under the conditions of the study, no evidence of acute systemic toxicity observed | Under the conditions of the study, no evidence of acute systemic toxicity observed | Similar | | | | | |
| | | Material<br>Mediated<br>Pyrogenicity,<br>ISO 10993-11 | ISO 10993-11<br>(E) | | | Under the conditions of the study, no evidence of material mediated pyrogenicity | | Under the conditions of the study, no evidence of material mediated pyrogenicity | | Similar |
| | Bacterial<br>Endotoxins | Not available | $\leq$ 20 EU/device | Different | | | | | | |
| | ANSI/AAMI<br>ST72 | | | | | | | | | |
| Watertight<br>(1000ml) | ASTM D5151 | ASTM D3577 when tested in accordance with ASTM D5151 | ASTM D3577 when tested in accordance with ASTM D5151 | Same |…