Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

K222058 · Wrp Asia Pacific Sdn. Bhd. · KGO · Oct 22, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K222058
• Device Name: Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Oct 22, 2022
• 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 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.

Device Story

Disposable, sterile, hand-specific surgical glove made of 100% synthetic polyisoprene latex. Designed for use by healthcare personnel in clinical settings to provide a barrier against cross-contamination. Features a smooth inner surface for easy donning without powder. Tested for permeation resistance against specific chemotherapy drugs and fentanyl citrate per ASTM D6978. Output is a physical barrier; healthcare providers use the glove to protect themselves and patients during procedures. Benefits include reduced risk of exposure to hazardous drugs and infectious agents.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D3577 (physical properties), ASTM D5151 (watertightness), ASTM D6124 (powder residue), ASTM D6978 (chemotherapy/fentanyl permeation), and ISO 10993 (biocompatibility).

Technological Characteristics

Material: 100% synthetic polyisoprene latex. Dimensions/Physical properties: ASTM D3577 compliant. Connectivity: None. Sterilization: Gamma radiation. Form factor: Hand-specific, powder-free, natural white color, bisque finish.

Indications for Use

Indicated for healthcare personnel as a protective barrier against cross-contamination between personnel and patients. Tested for use with 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 Polyisoprene Surgical Glove, Sterile (K032942)

Reference Devices

• Powder Free Nitrile Surgical Glove, Sterile, Tested for Use with Chemotherapy Drugs (K203030)

Submission Summary (Full Text)

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October 22, 2022

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

Re: K222058

Trade/Device Name: Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant 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 6, 2022 Received: July 12, 2022

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 medical devices and radiation-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 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 Ouality Center for Devices and Radiological Health

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#### Indications for Use

510(k) Number (if known) K222058

#### Device Name

POLYISOPRENE SURGICAL GLOVE, POWDER FREE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL RESISTANCE

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 | Concentration Average Breakthrough Detection Time (Minutes) |
|-----------------------------------------|-------------------------------------------------------------|
| *Carmustine (BCNU) (3.3 mg/ml) | 24.0 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Ifosfamide (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Mitoxantrone (2.0 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| *ThioTepa (10.0 mg/ml) | 23.1 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |

*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 24.0 minutes and Thiotepa: 23.1. Do not use with Carmustine and Thiotepa

| Fentanyl Resistance | Breakthrough Detection Time in Minutes |
|-----------------------------------------|----------------------------------------|
| Fentanyl Citrate Injection (100mcg/2mL) | No breakthrough up to 240 minutes |

Type of Use (Select one or both, as applicable)

| <div style="display:inline-block;">☐ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:inline-block;">❌ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# K222058

#### 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] |
| Date of Summary<br>Prepared | : 10/20/2022 |

#### 2.0 Identification of the subject device:

| Trade Name | : Polyisoprene Surgical Glove, Powder Free, Sterile,<br>Tested for Use with Chemotherapy Drugs and Fentany<br>Resistance |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------|
| Common Name | : Surgical Gloves |
| Classification Name | : Surgeon's Gloves |
| 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 Polyisoprene<br>Surgical Glove, Sterile |
| 510(k) Number | K032942 |
| Regulatory Class | I |
| Product Code | KGO |

#### 4.0 Reference Device:

| | Reference |
|------------------|----------------------------------------------------------------------------------------|
| Manufacturer | WRP Asia Pacific Sdn. Bhd. |
| Device name | Powder Free Nitrile Surgical Glove, Sterile, Tested<br>for Use with Chemotherapy Drugs |
| 510(k) Number | K203030 |
| Regulatory Class | I |
| Product Code | KGO, LZC |

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#### Description of The Device: 5.0

Powder Free Polyisoprene Surgical Glove, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance meets all the requirements of ASTM standard D3577, ASTM D6978-05 and FDA 21 CFR 878.4460.

The powder free polyisoprene surgical glove is manufactured from 100% synthetic polyisoprene latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of qlove, i.e., tensile strength meets ASTM standard D3577. Device is intended for single use.

The powder free polyisoprene surgical glove, sterile is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9. This glove comes in natural color and powder free.

#### 6.0 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 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 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

| Chemotherapy Drug Permeation<br>The following chemicals have been tested with these gloves. | | |
|---------------------------------------------------------------------------------------------|---------------|---------------------------------------------|
| Chemotherapy Drug | Concentration | Breakthrough<br>Detection Time<br>(Minutes) |
| *Carmustine (BCNU) | 3.3 mg/ml | 24.0 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | > 240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Ifosfamide | 50.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |

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| Mitoxantrone | 2.0 mg/ml | > 240 |
|---------------------|------------|-------|
| Paclitaxel | 6.0 mg/ml | > 240 |
| *ThioTepa | 10.0 mg/ml | 23.1 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |

*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 24.0 and ThioTepa: 23.1. Do not use with Carmustine and Thiotepa.

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

#### 7.0 Summary of the Technological Characteristics of the Device:

The Powder Free Polyisoprene Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs and Fentanyl Resistance are summarized with the following technological characteristics compared to ASTM D3577 or equivalent standards as shown in Table 1.

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#### Table 1

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | | COMPARISON ANALYSIS |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------------------------------------------------------------------------------|----------------------------|-----------------------------------------------------------------------------------|---------------------|
| | | PREDICATE | REFERENCE | CURRENT | |
| 510(k) Number | - | K032942 | K203030 | K222058 | - |
| Manufacturer(s) | - | WRP Asia Pacific Sdn. Bhd. | WRP Asia Pacific Sdn. Bhd. | WRP Asia Pacific Sdn. Bhd. | Same |
| Material | ASTM D3577 | Polyisoprene Rubber | Nitrile | Polyisoprene Rubber | Different |
| Color | - | Cream | Natural | Natural White | Different |
| Texture | - | Micro roughened | Bisque Finish | Bisque Finish | Different |
| Physical Properties | ASTM D3577 | Meets | Meets | Meets | Same |
| Before Aging<br>Tensile Strength:<br>Ultimate<br>Elongation:<br>Stress at 500%<br>Elongation:<br>After Aging<br>Tensile Strength:<br>Ultimate<br>Elongation:<br>Stress at 500%<br>Elongation: | | Min. 17MPa<br>Min. 650%<br>Max. 7.0MPa<br>Meets<br>Min. 12MPa<br>Min. 490%<br>N/A | Meets | Min. 17MPa<br>Min. 650%<br>Max. 7.0MPa<br>Meets<br>Min. 12MPa<br>Min. 490%<br>N/A | Same |

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| | STANDARD<br>S | DEVICE PERFORMANCE | | | | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| CHARACTERISTICS | | PREDICATE | REFERENCE | CURRENT | COMPARISON ANALYSIS | |
| 510(k) Number | - | K032942 | K203030 | K222058 | | |
| Thickness: | ASTM D3577 | Meets | Meets | Meets | Same | |
| - Finger<br>- Palm<br>- Cuff | | Min. 0.10 mm<br>Min. 0.10 mm<br>Min. 0.10 mm | Min. 0.10 mm | Min. 0.10 mm<br>Min. 0.10 mm<br>Min. 0.10 mm | | |
| Dimension, | ASTM D3577 | Meets | Meets | Meets | Same | |
| Length | | 5½: Min. 245mm | 5½: Min. 245 mm | 5½: Min. 245 mm | | |
| | | 6.0: Min. 265 mm | 6.0: Min. 265 mm | 6.0: Min. 265 mm | | |
| | | 6½: Min. 265 mm | 6½: Min. 265 mm | 6½: Min. 265 mm | | |
| | | 7.0: Min. 265 mm | 7.0: Min. 265 mm | 7.0: Min. 265 mm | | |
| | | 7½: Min. 265 mm | 7½: Min. 265 mm | 7½: Min. 265 mm | | |
| | | 8.0: Min. 265 mm | 8.0: Min. 265 mm | 8.0: Min. 265 mm | | |
| | | 8½: Min. 265 mm | 8½: Min. 265 mm | 8½: Min. 265 mm | | |
| | | 9.0: Min. 265 mm | 9.0: Min. 265 mm | 9.0: Min. 265 mm | | |
| Dimension, Width | ASTM D3577 | Meets | Meets | Meets | Same | |
| | | 5½: 70 ± 6 mm | 5½: 70 ± 6 mm | 5½: 70 ± 6 mm | | |
| | | 6.0: 76 ± 6 mm | 6.0: 76 ± 6 mm | 6.0: 76 ± 6 mm | | |
| | | 6½: 83 ± 6 mm | 6½: 83 ± 6 mm | 6½: 83 ± 6 mm | | |
| | | 7.0: 89 ± 6 mm | 7.0: 89 ± 6 mm | 7.0: 89 ± 6 mm | | |
| | | 7½: 95 ± 6 mm | 7½: 95 ± 6 mm | 7½: 95 ± 6 mm | | |
| | | 8.0: 102 ± 6 mm | 8.0: 102 ± 6 mm | 8.0: 102 ± 6 mm | | |
| | | 8½: 108 ± 6 mm | 8½: 108 ± 6 mm | 8½: 108 ± 6 mm | | |
| | | 9.0: 114 ± 6 mm | 9.0: 114 ± 6 mm | 9.0: 114 ± 6 mm | | |
| | STANDARDS | DEVICE PERFORMANCE | | | | |
| CHARACTERISTICS | | PREDICATE | REFERENCE | CURRENT | COMPARISON ANALYSIS | |
| 510(k) Number | | K032942 | K203030 | K222058 | | |
| Powder Free | ASTM D6124 | Meets<br>requirements of<br>≤2.0 mg/glove<br>for Powder-Free<br>designation per<br>ASTM D3577 | Meets<br>requirements of<br>≤2.0 mg/glove<br>for Powder-Free<br>designation per<br>ASTM D3577 | Meets<br>requirements of<br>≤2.0 mg/glove<br>for Powder-Free<br>designation per<br>ASTM D3577 | Same | |
| Biocompatibility | Primary Skin<br>Irritation -<br>ISO 10993-<br>10 (E) &<br>Consumer<br>Product<br>Safety<br>Commission<br>Title 16,<br>Chapter II,<br>Part 1500 | Passes (Not a<br>primary skin<br>irritant). | Passes (Not a<br>primary skin<br>irritant). | Passes (Not a<br>primary skin<br>irritant). | Similar | |
| | Dermal<br>Sensitization<br>- ISO<br>10993-10<br>(E) &<br>Consumer<br>Product<br>Safety<br>Commission,<br>Title 16,<br>Chapter II,<br>Part 1500.3<br>(c) (4) | Passes (Not a<br>contact sensitizer). | Passes (Not a<br>contact<br>sensitizer). | Passes (Not a<br>contact<br>sensitizer). | Similar | |
| CHARACTERISTICS | STANDARD<br>S | PREDICATE | DEVICE PERFORMANCE | REFERENCE | CURRENT | COMPARISON ANALYSIS |
| 510(k) Number | - | K032942 | | K203030 | K222058 | - |
| | Acute<br>Systemic<br>Toxicity, ISO<br>10993-11<br>(E) | N/a | | It is concluded<br>that the product<br>did not induce<br>any systemic<br>toxicity | It is concluded<br>that the product<br>did not induce<br>any systemic<br>toxicity | Different |
| | Material<br>Mediated<br>Pyrogenicity,<br>ISO 10993-<br>11 (E) | N/a | | It is concluded<br>that the product<br>is considered to<br>be non-pyrogenic | It is concluded<br>that the product<br>is considered to<br>be non-pyrogenic | Different |
| Watertight<br>(1000ml) | ASTM D5151 | Meets 21 CFR<br>800.20 and<br>ASTM D3577 when<br>tested in<br>accordance with<br>ASTM D5151<br>Inspection Level 1,<br>AQL 1.5. | | Meets 21 CFR<br>800.20 and ASTM<br>D3577 when<br>tested in<br>accordance with<br>ASTM D5151<br>Inspection Level<br>I, AQL 0.65 | Meets 21 CFR<br>800.20 and ASTM<br>D3577 when<br>tested in<br>accordance with<br>ASTM D5151<br>Inspection Level<br>I, AQL 0.65 | Similar (AQL was subsequently<br>lowered after FDA cleared the<br>predicate) |
| Intended use /<br>Indications for Use | - | A powder free,<br>polymer coated<br>polyisoprene<br>surgical glove,<br>sterile, is made of<br>synthetic rubber<br>latex and intended<br>to be worn on the<br>hand of healthcare<br>personnel | | A powder-free<br>sterile surgeon's<br>glove is a<br>disposable device<br>made of synthetic<br>rubber intended<br>to be worn on the<br>hands of<br>healthcare<br>personnel as a | A powder-free<br>sterile surgeon's<br>glove is a<br>disposable device<br>made of synthetic<br>rubber intended<br>to be worn on the<br>hands of<br>healthcare<br>personnel as a | Same with additional characteristics. |
| CHARACTERISTICS | STANDARDS | PREDICATE | DEVICE PERFORMANCE<br>REFERENCE | CURRENT | COMPARISON ANALYSIS | |
| <b>510(k) Number</b> | - | K032942 | K203030 | K222058 | - | |
| | | operating room<br>personnel and<br>similar personnel<br>to prevent<br>contamination<br>between the<br>healthcare or<br>similar personnel<br>and the patient's<br>body, fluids,<br>waste, or<br>environment. | barrier for<br>protection against<br>cross-<br>contamination<br>between the<br>healthcare<br>personnel and<br>patient.<br>These gloves<br>were tested for<br>use with<br>chemotherapy<br>drugs in<br>accordance with<br>ASTM D6978-05<br>Standard Practice<br>for Assessment of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy<br>Drugs. | barrier for<br>protection against<br>cross-<br>contamination<br>between the<br>healthcare<br>personnel and<br>patient.<br>These gloves<br>were tested for<br>use with<br>Chemotherapy<br>Drugs and<br>Fentanyl Citrate<br>as per ASTM<br>D6978 Standard<br>Practice for<br>Assessment of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy<br>Drugs | | |
| CHARACTERISTICS | STANDARD<br>S | PREDICATE | REFERENCE | CURRENT | COMPARISON ANALYSIS | |
| 510(k) Number | - | K032942 | K203030 | K222058 | - | |
| Size | Medical<br>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 | 5½<br>6.0<br>6½<br>7.0<br>7½<br>8.0<br>8½<br>9.0 | Same | |
| Single Use | Medical<br>Glove<br>Guidance<br>Manual -<br>Labeling | Single use | Single use | Single use | Same…