Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K200181 · Comfort Rubber Gloves Industries Sdn. Bhd. · LZA · Apr 15, 2020 · General Hospital

Device Facts

• Record ID: K200181
• Device Name: Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
• Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Apr 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs and Fentanyl Citrate. Tested for use with chemotherapy drugs and fentanyl citrate.

Device Story

Disposable, non-sterile, black nitrile examination glove; worn by healthcare personnel to prevent cross-contamination and protect against chemotherapy drug/Fentanyl Citrate exposure. Device acts as a physical barrier. Performance validated via permeation testing against specific chemotherapy agents and Fentanyl Citrate per ASTM D6978-05. Used in clinical settings; operator is the healthcare provider. Output is the physical barrier provided by the glove; clinical decision-making involves selecting appropriate PPE based on drug permeation data. Benefits include reduced risk of chemical exposure and infection transmission.

Clinical Evidence

Bench testing only. No clinical data. Performance demonstrated via physical property testing (tensile strength, elongation), freedom from holes (ASTM D5151), residual powder content (ASTM D6124), and chemical permeation resistance (ASTM D6978). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).

Technological Characteristics

Material: Nitrile. Form factor: Disposable, powder-free, black, non-sterile examination glove. Dimensions: Length min 240mm, thickness min 0.05mm. Standards: ASTM D6319-10(2015), ASTM D6978-05(2019), ASTM D412, ASTM D573, ASTM D3767, ASTM D5151, ASTM D6124, ISO 2859, ISO 10993-5, ISO 10993-10. Connectivity: None. Energy source: None.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between examiner and patient, and to protect the wearer against exposure to 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, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K183287)

Submission Summary (Full Text)

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August 29, 2022

Comfort Rubber Gloves Industries Sdn. Bhd. Ng Howe QA Manager Lot 821, Jalan Matang Matang, Perak 34750 Malaysia

Re: K200181

Trade/Device Name: Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC

Dear Ng Howe:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 15, 2020. Specifically, FDA is updating this SE Letter for a typographical error contained in the Indications for Use, as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, Office of Surgical and Infection Control Devices, at: [phone] or [e-mail].

Sincerely,

# Bifeng Qian -S

Bifeng Qian, 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

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April 15, 2020

Comfort Rubber Gloves Industries Sdn. Bhd. Ng Howe QA Manager Lot 821, Jalan Matang Matang, 34750 My

Re: K200181

Trade/Device Name: Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: January 22, 2020 Received: January 24, 2020

Dear Ng Howe:

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/ofdocs/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Image /page/2/Picture/5 description: The image shows the name "Elizabeth F. Claverie -S" in a simple, sans-serif font. The text is arranged vertically, with "Elizabeth F." on the first line and "Claverie -S" on the second line. The background is plain white.

CAPT Elizabeth Claverie, M.S. 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)

#### K200181

Device Name

Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Indications for Use (Describe)

The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these qloves are worn to protect the wearer aqainst exposure to chemotherapy drugs. Tested for use chemotherapy drugs and Fentanyl Citrate. Tested chemotherapy drugs are as follows:

| | Average Breakthrough Detection Time (minutes) |
|-------------------------------------|-----------------------------------------------|
| Cisplatin 1.0 mg/ml | ≥ 240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | ≥ 240 |
| Dacarbazine (DTIC) 10.0 mg/ml | ≥ 240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | ≥ 240 |
| Etoposide (Toposar) 20.0 mg/ml | ≥ 240 |
| Fluorouracil 50.0 mg/ml | ≥ 240 |
| Paclitaxel (Taxol) 6.0 mg/ml | ≥ 240 |
| *Carmustine (BCNU) 3.3mg.ml | 54.1 (minutes) |
| *Thiotepa 10.0 mg/ml | 6.0 (minutes) |

*Please note that these drugs have extremely low permeation time CAUTION: Testing showed an average breakthrough time of 54.1 minutes with Carmustine. WARNING: Do not use with Thiotepa.

| Tested Fentanyl Citrate is as follows: | Fentanyl Citrate Injection 100.0 mcg/2ml |
|-----------------------------------------------|------------------------------------------|
| Average Breakthrough Detection Time (minutes) | ≥ 240 |

Prescription Use (Part 21 CFR 801 Subpart D)

| X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY

## K200181

Prepared according to 21 CFR § 807.92 Preparation Date: April 10, 2020

#### 1. Submitter

Name: Comfort Rubber Gloves Industries Sdn. Bhd. Address: Lot 821, Jalan Matang, 34750 Matang, Perak, Malaysia. Phone No.: 605-847 2777 Fax No .: 605-847 9108 Contact Person: Ng Kok Howe (Mr.)

#### 2. Identification of the Device

Device name: Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Common Name: Patient Examination Gloves

Classification Name: Patient Examination Gloves

Regulation: 21 CFR 880.6250

Product code: LZA

Classification Name: Patient Examination Gloves Specialty

Regulation: 21 CFR 880.6250

Product code: LZC

#### 3. Identification of the Legally Marketed Device as Predicate

Predicate Device Name: 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, Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Company: Kossan International Sdn. Bhd.

Predicate 510(K) No.: K183287

#### 4. Description of the Device:

Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate meets the requirements of ASTM D6319-10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.

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| Reference<br>Standard | Glove size | Standard Requirements | |
|-----------------------|------------|-----------------------|-------------|
| | | Palm width (mm) | Length (mm) |
| ASTM 6319 | XS | $75 \pm 5$ mm | Min 240 |
| | S | $85 \pm 5$ mm | |
| | M | $95 \pm 5$ mm | |
| | L | $105 \pm 5$ mm | |
| | XL | $115 \pm 5$ mm | |

Table 1. Glove Specifications for different models

## 5. Indications for Use

The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs and Fentanyl Citrate. Tested for use with chemotherapy drugs and fentanyl citrate.

# 6. Comparison of the Technological Characteristics between the Subject and Predicate Devices

The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are summarized with the following technological characteristics compared to ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in Table 1. Chemotherapy claim is similar to the predicate.

| Characteristics | Standards | Device performance | | Remarks |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | | Predicate device | Subject device | |
| Manufacturer(s) | | Kossan International Sdn.<br>Bhd. | Comfort Rubber Gloves<br>Industries Sdn. Bhd | - |
| 510(k) number | | K183287 | K200181 | - |
| Indication for Use | | A patient examination<br>glove is a disposable device<br>intended for medical<br>purpose that is worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner. | The Black Colored, Power<br>Free Nitrile Examination<br>Gloves, Non-sterile, and<br>Tested for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate is a<br>specialty medical glove<br>which is a disposable device<br>intended for medical purpose<br>that is worn on the<br>examiner's hand or finger to<br>prevent contamination<br>between examiner and<br>patient. In addition, these<br>gloves are worn to protect<br>the wearer against exposure<br>to chemotherapy drugs and<br>Fentanyl Citrate. Tested for<br>use with chemotherapy drugs<br>and Fentanyl Citrate. Tested<br>chemotherapy drugs are as<br>follows: | Same |
| | | These gloves were tested<br>for use with chemotherapy<br>drugs and Fentanyl Citrate<br>per ASTM D6978-05<br>(Reapproved 2013)<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs.<br>Minimum Breakthrough<br>Detection Time in minutes | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | Carmustine (BCNU)<br>(3.3mg/ml) - 10.1 Cisplatin,<br>(1.0 mg/ml) - >=240 | | |
| | | Cyclophosphamide | Average Breakthrough | |
| | | (Cytoxan), 20.0 mg/ml - >= | Detection Time (minutes) | |
| | | 240 Cytarabine (100 mg/ml) | Cisplatin, 1.0 mg/ml - | |
| | | >=240 | >=240 | |
| | | Dacarbazine (DTIC), 10.0 | Cyclophosphamide | |
| | | mg/ml >=240 | (Cytoxan), 20.0 mg/ml | |
| | | Doxorubicin Hydrochloride, | ->=240 | |
| | | (2.0 mg/ml) >=240 | Dacarbazine (DTIC), | |
| | | Etoposide, (20.0 mg/ml) | 10.0 mg/ml - >=240 | |
| | | >=240 | Doxorubicin Hydrochloride, | |
| | | Fluorouracil, (50.0 mg/ml) | 2.0 mg/ml ->=240 | |
| | | >=240 | Etoposide (Toposar), 20.0 | |
| | | lfosfamide (50.0 mg/ml) | mg/ml ->=240 | |
| | | >=240 | Fluorouracil, 50.0mg/ml - | |
| | | Methotrexate (25.0 mg/ml) | >=240 | |
| | | >=240 | Paclitaxel (Taxol), 6.0mg/ml | |
| | | Mitomycin C (0.5 mg/ml) | >=240 | |
| | | >=240 | *Carmustine (BCNU) | |
| | | Mitoxantrone (2.0 mg/ml) | 3.3mg/ml - 54.1 (mins) | |
| | | >=240 | *Thiotepa 10.0 mg/ml | |
| | | Paclitaxel (Taxol), 6.0 mg/ml | - 16.0 (mins) | |
| | | >=240 | *Please note that these drugs | |
| | | Thiotepa (10.0 mg/ml) - 30.2 | have extremely low | |
| | | Vincristine Sulfate (1.0mg/ml) | permeation time. | |
| | | >=240. | CAUTION: Testing showed | |
| | | Please note that Carmustine | an average breakthrough | |
| | | (BCNU) has extremely low | time of 54.1 minutes with | |
| | | permeation time of 10.1 | Carmustine; WARNING: Do | |
| | | minutes. Fentanyl Citrate and | not use with Thiotepa. | |
| | | Concertation Fentanyl Citrate | Tested Fentanyl Citrate is as | |
| | | Injection (100.0 mcg/2ml) | follows: Fentanyl Citrate | |
| | | Minimum Breakthrough | Injection 100.0 mcg/2ml | |
| | | Detection Time in | Average Breakthrough | |
| | | minutes>=240 | Detection Time | |
| | | | (minutes) >=240 | |
| | ASTM D6319- | Length-Min 240mm | Length-Min 240mm Thickness | |
| Dimension | 10(2015) | Thickness palm and finger- | palm and finger- Min 0.05mm | Similar |
| | | Min 0.05mm | | |
| Physical Properties | ASTM D6319- | Meets | Meets | Similar |
| | 10(2015) | | | |
| Thickness - Finger- | ASTM D6319- | Meets | Meets | Similar |
| Palm | 10(2015) | | | |
| Powder Content | ASTM D6124- | Meets | Meets | Similar |
| | 06(2011) | | | |
| Chemotherapy | Concentration | | Minimum Breakthrough Detection Time (min) | |
| Drugs | | | | |
| Cisolatin | 1.0 mg/ml | >240 | >240 | Same |
| Cyclophosphamide | 20 mg/ml | >240 | >240 | Same |
| (Cvtoxan) | | | | |
| Dacarbazine (DTIC) | 10.0 mg/ml | >240 | >240…