Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

K210330 · Wrp Asia Pacific Sdn. Bhd. · LZA · Mar 4, 2022 · General Hospital

Device Facts

• Record ID: K210330
• Device Name: Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Mar 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination glove; worn on hand/finger by healthcare providers to prevent cross-contamination. Manufactured from synthetic rubber; surface treated for smooth donning without powder. Ambidextrous design. Tested for permeation resistance against various chemotherapy drugs and fentanyl citrate per ASTM D6978-05. Used in clinical settings; provides a physical barrier between patient and examiner. Output is the barrier protection itself; healthcare providers use the glove to maintain hygiene and safety during patient examinations and handling of hazardous substances. Benefits include reduced risk of contamination and protection against specific chemical exposures.

Clinical Evidence

No clinical data. Bench testing only, including physical properties (ASTM D412), dimensions (ASTM D3767), watertightness (ASTM D5151), residual powder (ASTM D6124), and chemotherapy/fentanyl permeation (ASTM D6978).

Technological Characteristics

Material: Nitrile (synthetic rubber). Form factor: Ambidextrous, powder-free, black, hand-textured. Standards: ASTM D6319, ASTM D6978, ASTM D5151, ASTM D6124, ASTM D412, ASTM D3767. Biocompatibility: ISO 10993-5, 10993-10, 10993-11. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs and fentanyl citrate.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K183287)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 4, 2022

WRP Asia Pacific SDN BHD % Saravanan Ramasamy HEAD of QARA Wrp Usa Inc 3700 Massillon Road. Suite 340 Uniontown, Ohio 44685

Re: K210330

Trade/Device Name: Dermagrip Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO Dated: February 8, 2022 Received: February 14, 2022

Dear Saravanan Ramasamy:

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.

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

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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,

Clarence W. Murray, III, PhD 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) K210330

### Device Name

DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVE, NON STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL RESISTANCE

### Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and Fentany] Citrate per ASTM D6978-05 (Re-approved 2013) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug | Breakthrough Detection Time in Minutes |
|----------------------------|----------------------------------------|
| *Carmustine (BCNU) | 21.2 |
| Cisplatin | > 240 |
| Cyclophosphamide (Cytoxan) | > 240 |
| Dacarbazine | > 240 |
| Doxorubicin Hydrochloride | > 240 |
| Etoposide | > 240 |
| Fluorouracil | > 240 |
| Ifosfamide | > 240 |
| Methotraxate | > 240 |
| Mitomycin C | > 240 |
| Mitoxantrone | > 240 |
| Paclitaxel | > 240 |
| *Thiotepa | 34.6 |
| Vincristine Sulfate | > 240 |

* WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 21.1 minutes and Thiotepa: 34.6. Do not use with Carmustine and Thiotepa.

| Fentanyl Resistance | Breakthrough Detection Time in Minutes |
|----------------------------|----------------------------------------|
| Fentanyl Citrate Injection | No breakthrough up to 240 minutes |

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

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

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#### 1.0 Submitter:

| Name: | Saravanan Ramasamy |
|------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | WRP Asia Pacific Sdn Bhd<br>Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi,<br>43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | [phone] |
| Fax No.: | [phone] |

Date of Summary Prepared: 3 March 2022

#### 2.0 Identification of the subject device:

: Dermagrip Powder Free Black Nitrile Patient Examination Trade Name Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance Common Name : Patient Examination Gloves Classification Name : Patient Examination Gloves Device Classification : 1 Regulation Number : 21 CFR 880.6250 Product Code

### 3.0 Predicate Device:

## K183287

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.

Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.

Company: Kossan International Sdn. Bhd.

#### 4.0 Description of The Device:

Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Fentanyl Resistance meet all requirements of ASTM D6319, ASTM D6978, and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from nitrile, a synthetic rubber. 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 ambidextrous, i.e. can be worn on right hand or left hand.

#### 5.0 Indication for use:

Dermagrip Powder Free Black Nitrile Patient Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance is a disposable device made of synthetic rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device has also been tested for use with fentanyl citrate.

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:

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### Chemotherapy Drug Permeation

The following chemicals have been tested for the glove.

| Chemotherapy Drug | Concentration | Breakthrough Detection<br>Time in Minutes |
|----------------------------|---------------|-------------------------------------------|
| *Carmustine (BCNU) | 3.3mg/ml | 21.2 |
| Cisplatin | 1.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| *Thiotepa | 10.0mg/ml | 34.6 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
| Methotrexate | 25.0mg/ml | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 |

*WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 21.1 minutes and Thiotepa: 34.6. 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 |

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

Dermagrip Powder Free Black Nitrile Patient Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1.

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| Table 1 | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--|
| | | DEVICE PERFORMANCE | | | |
| CHARACTERISTICS | STANDARDS | PREDICATE | SUBJECT DEVICE | COMPARISON<br>ANALYSIS | |
| | | BLUE | DERMAGRIP POWDER FREE BLACK<br>NITRILE PATIENT EXAMINATION<br>GLOVE, NON-STERILE, TESTED FOR<br>USE WITH CHEMOTHERAPY DRUGS<br>AND FENTANYL RESISTANCE | | |
| 510(k) Number | - | K183287 | K210330 | | |
| Manufacturer(s) | - | Kossan International Sdn. Bhd. | WRP Asia Pacific | Same | |
| Material | ASTM D6319 | Nitrile | Nitrile | Same | |
| Color | - | Blue | Black | Same | |
| Texture | - | Fingertips textured | Hand textured (Fully textured<br>surface from fingertips to end of<br>palm ) | Different | |
| Physical Properties | ASTM D6319 | Meets | Meets | | |
| Before Aging<br>Tensile Strength: | | 28Mpa min | 14MPa min | Different but | |
| Ultimate Elongation: | | 500% min | 500% min | within the ASTM<br>standard | |
| After Aging<br>Tensile Strength:<br>Ultimate Elongation: | | 30Mpa min<br>480% min | 14MPa min<br>400% min | Different but<br>within the ASTM<br>standard | |
| Thickness :<br>- Finger<br>- Palm<br>- Cuff | ASTM D6319 | 0.10mm<br>0.06mm<br>0.04mm | 0.05mm min<br>0.05mm min<br>0.05mm min | Different but<br>within the ASTM<br>standard | |
| Powder Free | ASTM D6124 | Less than 2mg per glove | Less than 2mg per glove | Same | |
| CHARACTERISTICS STANDARDS | DEVICE PERFORMANCE | | | COMPARISON ANALYSIS | |
| | PREDICATE | SUBJECT DEVICE | | | |
| | BLUE | DERMAGRIP POWDER FREE BLACK<br>NITRILE PATIENT EXAMINATION<br>GLOVE, NON-STERILE, TESTED FOR<br>USE WITH CHEMOTHERAPY DRUGS<br>AND FENTANYL RESISTANCE | | | |
| Primary Skin Irritation<br>- ISO 10993-10:2010<br>(E) & Consumer<br>Product Safety<br>Commission Title 16.<br>Chapter II, Part 1500 | Non Irritating | Passes (Not a primary skin<br>irritant)<br>There was no erythema or<br>oedema noted on test site after<br>(24±2), (48±2) and (72±2)<br>hours. The primary Irritation<br>Index (PII) was "0" | | Similar | |
| Biocompatibility | Dermal Sensitization-<br>ISO 10993-10: 2010<br>(E) & Consumer<br>Product Safety<br>Commission, Title 16,<br>Chapter II, Part<br>1500.3 (c) (4) | Non Sensitization | Passes (Not a contact<br>sensitizer).<br>There was no positive allergic<br>reaction observed during the<br>challenge phase (at 0, 24<br>hours and 48 hours) in animals<br>treated with the test material<br>and negative control. | Similar | |
| | Cytotoxicity - MEM<br>Elution, ISO 10993-5:<br>2009 (E) | Non Cytotoxic | Acute systemic toxicity testing<br>performed to demonstrate<br>safety. | Different | |

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| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON<br>ANALYSIS |
|---------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | | PREDICATE<br>BLUE | SUBJECT DEVICE | |
| | | | DERMAGRIP POWDER FREE BLACK<br>NITRILE PATIENT EXAMINATION<br>GLOVE, NON-STERILE, TESTED FOR<br>USE WITH CHEMOTHERAPY DRUGS<br>AND FENTANYL RESISTANCE | |
| Biocompatibility | Acute Systemic<br>Toxicity, ISO 10993-<br>11:2017 (E) | Not Available | It is concluded that the product<br>did not induce any systemic<br>toxicity. | Different |
| Watertight (1000ml) | ASTM D5151:2019 | Inspection Level 1, AQL 1.5 | Inspection Level 1, AQL 1.5 | Same |
| Intended use | - | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand to<br>prevent contamination between<br>patient and examiner. | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>or finger to prevent<br>contamination between patient<br>and examiner. | Same |
| Size | Medical Glove<br>Guidance Manual -<br>Labeling | X Small<br>Small<br>Medium<br>Large<br>Extra Large | X Small<br>Small<br>Medium<br>Large<br>Extra Large | Same |
| Single use | Medical Glove<br>Guidance Manual -<br>Labeling | Single use | Single use | Same |

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| | | DEVICE PERFORMANCE | | |
|----------------------------------------|---------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| CHARACTERISTICS | STANDARD | PREDICATE | SUBJECT DEVICE | COMPARISON ANALYSIS |
| | S | BLUE | DERMAGRIP POWDER FREE BLACK<br>NITRILE PATIENT EXAMINATION<br>GLOVE, NON-STERILE, TESTED FOR<br>USE WITH CHEMOTHERAPY DRUGS<br>AND FENTANYL RESISTANCE | |
| Chemotherapy Drugs | | Minimum Breakthrough | Minimum Breakthrough | |
| Permeation Test | | Detection Time in Minutes | Detection Time in Minutes | |
| Carmustine (BCNU) (3.3mg/ml) | | 10.1 | 21.1 | Different |
| Cisplatin (1.0mg/ml) | | >240 | >240 | Same |
| Cyclophosphamide (Cytoxan) (20.0mg/ml) | | >240 | >240 | Same |
| Cytarabine (100.0mg/ml) | | >240 | Not Available | Different |
| Dacarbazine (10.0mg/ml) | | >240 | >240 | Same |
| Doxorubicin Hydrochloride (2.0mg/ml) | | >240 | >240 | Same |
| Etoposide (Toposar) (20.0mg/ml) | | >240 | >240 | Same |
| Fluorouracil (50.0mg/ml) | ASTM<br>D6978 | >240 | >240 | Same |
| Ifosfamide (50.0mg/ml) | | >240 | >240 | Same |
| Methotrexate (25.0mg/ml) | | >240 | >240 | Same |
| Mitoxantrone (2.0mg/ml) | | >240 | >240 | Same |
| Mitomycin C (0.5mg/ml) | | >240 | >240 | Same |
| Paclitaxel (Taxol) (6.0mg/ml) | | >240 | >240 | Same |
| *Thiotepa (10.0mg/ml) | | 30.2 | 34.6 | Different |
| Vincristine Sulfate (1.0mg/ml) | | >240 | >240 | Same |
| Warning Statement | | Please note that Carmustine (BCNU)<br>has extremely low permeation times<br>of 10.1 minutes | WARNING: Please note the following<br>drugs have extremely low permeation<br>times: Carmustine (BCNU): 21.1 minutes<br>and Thiotepa: 34.6. Do not use with<br>Carmustine and Thiotepa. | Different |
| Fentanyl Resistant (100mcg/2ml) | ASTM D6978 | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | Same |

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There are no significant differences between the two products and are identical in terms of intended use, materials design, manufacturing methods except for color, physical properties and thickness.

### 7.0 Summary of Non-Clinical Testing

The performance test data of the non-clinical test for this powder free nitrile examination glove is summarized as per below.

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| Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | | Results | | |
|------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------|-----------------|-----------------|------|------|
| Physical<br>Properties | ASTM D412<br>(Standard Test<br>Method for<br>Vulcanized Rubber<br>and Thermoplastic<br>Elastomers-Tension) | To evaluate the<br>tensile (tension)<br>properties of glove. | Tensile<br>strength | Min 14.0<br>MPa | Min 14.0<br>MPa | Pass | Pass |
| | | | Ultimate<br>elongation | Min<br>500% | Min<br>400% | Pass | Pass |

| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | | Results |
|----------------|-------------------------------------|-------------------------------------|--------------------------|---------------------|---------|
| Dimension | ASTM D3767<br>Standard Practice for | To measure the<br>length, width and | Length<br>(all sizes) | Min 240 mm | Pass |
| | Rubber- | thickness<br>of | Width | XS: ≤ 80 mm | Pass |
| | Measurement of | glove | | S: 80 ± 10 | Pass |
| | Dimensions | | | M: 95 ± 10 | Pass |
| | | | | L: 110 ± 10 | Pass |
| | | | | XL: ≥ 110 | Pass |
| | | | Thickness<br>(all sizes) | Finger: Min 0.05 mm | Pass |
| | | | | Palm: Min 0.05 mm | Pass |
| | | | | Cuff: Min 0.05 mm | Pass |

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| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results |
|----------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|---------|
| Watertight | ASTM D5151<br>(Standard Test<br>Method for<br>Detection of Holes<br>in Medical Gloves) | To detect holes<br>that leak water<br>and thereby<br>compromise the<br>usefulness of the<br>glove. | Sample size: 500 pcs<br>Inspection level: G1<br>AQL: 1.5, Acceptance No. 10,<br>Found 2 | Pass |

| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results |
|--------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------|---------|
| Residual<br>Powder | ASTM D6124<br>(Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves) | To determine the<br>amount of<br>residual powder<br>and non-powder<br>solids found on<br>gloves. | Less than 2 mg per glove | Pass |

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### 8.0 Summary of Clinical Testing:

No clinical study is included in this submission.

### 9.0 Conclusion

The conclusion drawn from the non-clinical tests demonstrate that the subject device (Dermagrip Powder Free Black Nitrile Patient Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance) is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K183287.