Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K222907 · Rmkh Glove (Cambodia) Co., Ltd. · LZA · Jan 4, 2023 · General Hospital

Device Facts

• Record ID: K222907
• Device Name: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
• Applicant: Rmkh Glove (Cambodia) Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jan 4, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Nitrile Powder Free Examination Glove 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. The glove was 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, non-sterile, ambidextrous nitrile examination glove; blue colored with beaded cuff. Used by healthcare professionals to prevent cross-contamination between examiner and patient. Tested for permeation resistance against various chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05. Input: physical barrier against chemical/biological agents. Output: protective barrier. Clinical benefit: reduces risk of exposure to hazardous drugs and patient-to-examiner contamination. Used in clinical settings; OTC use.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated per ASTM D6319-19 (physical dimensions, tensile strength, elongation), ASTM D5151-19 (watertightness/holes), ASTM D6124-06 (residual powder), and ASTM D6978-05 (chemotherapy permeation). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Material: Nitrile. Form: Powder-free, ambidextrous, beaded cuff, blue. Dimensions: Length ≥220mm (XS/S) or ≥230mm (M/L/XL). Standards: ASTM D6319-19, ASTM D6978-05, ASTM D5151-19, ASTM D6124-06. Biocompatibility: ISO 10993-5, 10, 11. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between examiner and patient. Suitable for use with specific chemotherapy drugs and Fentanyl Citrate. Warning: Do not use with Carmustine and ThioTepa.

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

• Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954)

Submission Summary (Full Text)

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January 4, 2023

RMKH Glove (Cambodia) Co., Ltd. % Boyle Wang Official Correspondent ABMED Service Inc 1312 17th Street Suite 692 Denver, Colorado 80202

#### Re: K222907

Trade/Device Name: Nitrile Powder Free Examination Glove 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, ODO, OPJ Dated: November 15, 2022 Received: November 15, 2022

Dear Boyle Wang:

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

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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 Qian, M.D., 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) K22907

#### Device Name

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

#### Indications for Use (Describe)

The Nitrile Powder Free Examination Glove 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. The glove was 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.

Tested chemotherapy drugs are as follows:

| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---------------------|---------------|----------------------------------------|
| Carmustine | 3.3 mg/ml | 22.6 Minutes |
| Cisplatin | 1.0 mg/ml | 240 Minutes |
| Cyclophosphamide | 20.0 mg/ml | 240 Minutes |
| Dacarbazine | 10.0 mg/ml | 240 Minutes |
| Doxorubicin HCI | 2.0 mg/ml | 240 Minutes |
| Etoposide | 20.0 mg/ml | 240 Minutes |
| Fluorouracil | 50.0 mg/ml | 240 Minutes |
| Methotrexate | 25.0 mg/ml | 240 Minutes |
| Mitomycin C | 0.5 mg/ml | 240 Minutes |
| Paclitaxel | 6.0 mg/ml | 240 Minutes |
| ThioTepa | 10.0 mg/ml | 11.0 Minutes |
| Vincristine Sulfate | 1.0 mg/ml | 240 Minutes |

Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 22.6 Minutes; ThioTepa 10.0 mg/ml 11.0 Minutes.

Tested Fentanyl Citrate is as follows: Chemotherapy Drug Fentanyl Citrate Injection

Concentration 100.0 mcg/2ml

Breakthrough Detection Time in Minutes 240 Minutes

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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# 510(k) Summary K22907

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

#### 1.0 Submitter's Information

RMKH GLOVE (CAMBODIA) CO., LTD. Name: Address: Manhattan Special Economic Zone, Bavet Commune, Bavet City, Svay Rieng Province, Cambodia Contact: Yang Clement KC Date of Preparation: Dec 28, 2022

#### Designated Submission Correspondent

Mr. Boyle Wang ABMED SERVICE INC Room 1312 17th Street Suite 692 Denver, CO US 80202 Tel: [phone] Email: [e-mail]

#### 2.0 Device Information

Nitrile Powder Free Examination Glove Tested for Use Trade name: with Chemotherapy Drugs and Fentanyl Citrate Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove XS, S, M, L, XL Model(s):

#### 3.0 Classification

Production code: LZA, LZC, QDO, OPJ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital

#### 4.0 Predicate Device Information

Comfort Rubber Gloves Industries Sdn. Bhd Manufacturer: Device: Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 510(k) number: K192954

#### 5.0 Device Description

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The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in five sizes: XS, S, M, L, XL. The subject device is non-sterile.

#### 6.0 Indication for Use

The Nitrile Powder Free Examination Glove 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. The glove was 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 | Breakthrough Detection<br>Time in Minutes |
|----------------------------|---------------|-------------------------------------------|
| Carmustine | 3.3 mg/ml | 22.6 |
| Cisplatin | 1.0 mg/ml | > 240 |
| Cyclophosphamide | 20.0 mg/ml | > 240 |
| Dacarbazine | 10.0 mg/ml | > 240 |
| Doxorubicin HCI | 2.0 mg/ml | > 240 |
| Etoposide | 20.0 mg/ml | > 240 |
| Fluorouracil | 50.0 mg/ml | > 240 |
| Methotrexate | 25.0 mg/ml | > 240 |
| Mitomycin C | 0.5 mg/ml | > 240 |
| Paclitaxel | 6.0 mg/ml | > 240 |
| Thio Tepa | 10.0 mg/ml | 11.0 |
| Vincristine Sulfate | 1.0 mg/ml | > 240 |
| Fentanyl Citrate Injection | 100.0 mcg/2ml | > 240 |

Tested chemotherapy drugs are as follows:

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 22.6 Minutes; Thio Tepa 10.0 mg/ml 11.0 Minutes.

Warning: Please do not use with Carmustine and ThioTepa.

# 7.0 Technological Characteristic Comparison Table

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| Item | Subject Device<br>(K222907) | Predicate Device<br>(K192954) | Remark |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product Code | LZA,LZC,QDO, OPJ | LZA,LZC,QDO | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Nitrile Powder Free<br>Examination Glove Tested<br>for Use with<br>Chemotherapy Drugs and<br>Fentanyl Citrate is a<br>specialty medical glove<br>which is a disposable<br>device intended for<br>medical purpose that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>examiner and patient. The<br>glove was tested for use<br>with Chemotherapy Drugs<br>and Fentanyl Citrate as per<br>ASTM D6978-05 Standard<br>Practice for Assessment of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs. | The Blue Colored, Powder<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<br>device intended for<br>medical purpose that is<br>worn on the examiner' s<br>hand or finger to prevent<br>contamination between<br>examiner and patient. The<br>glove was tested for use<br>with Chemotherapy Drugs<br>and Fentanyl Citrate as per<br>ASTM D6978-05 Standard<br>Practice for Assessment of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs. | Same |
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Labeling Information | Single-use indication,<br>powder free, device color,<br>device name, glove size<br>and quantity,Non-Sterile,<br>a statement of standard<br>ASTM D6978-05<br>compliance and a<br>summary of the testing<br>results. | Single-use indication,<br>powder free, device color,<br>device name, glove size<br>and quantity, Non-Sterile,<br>a statement of standard<br>ASTM D6978-05<br>compliance and a<br>summary of the testing<br>results. | Same |
| Dimensions(mm) | Length:<br>XS/S:≥220;<br>M/L/XL: ≥230; | Length:<br>XS/S/M/L/XL: ≥240;<br>Width: | Similar |

#### Table1-General Comparison

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| | Width: | | | | | | |
|--------------------------------------------------------------------------------|-------------------------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------|
| | XS: 70±10; | XS:70±10; | | | | | |
| | S: 80±10; | S: 80±10; | | | | | |
| | M: 95±10; | M: 95±10; | | | | | |
| | L: 110±10; | L: 110±10; | | | | | |
| | XL: 120±10. | XL: 120±10 | | | | | |
| | | Finger: ≥0.05; | Finger: ≥0.05; | Same | | | |
| | Thickness(mm) | | Palm: ≥0.05 | | Palm: ≥0.05 | | |
| | Colorant | | Blue | | Blue | Same | |
| | Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 14MPa,<br>min | Tensile<br>Strength | 14MPa,<br>min | Same |
| | | | Ultimate<br>Elongation | 500% min | Ultimate<br>Elongation | 500% min | Same |
| | | After Aging | Tensile<br>Strength | 14MPa,<br>min | Tensile<br>Strength | 14MPa,<br>min | Same |
| | | | Ultimate<br>Elongation | 400%min | Ultimate<br>Elongation | 400%min | Same |
| | Freedom from Holes | | Be free from holes when<br>tested in accordance<br>with ASTMD5151<br>AQL=2.5 | | Be free from holes when<br>tested in accordance<br>with ASTMD5151<br>AQL=2.5 | | Same |
| | Powder Content | | 0.16~0.30 mg per glove,<br>Meet the requirements<br>of ASTM D6124 | | Meet the requirements<br>of ASTM D6124 | | Similar |
| | Biocompatibility | | ISO 10993-10;<br>Under the conditions of<br>the study, not an irritant<br>or a sensitizer<br>ISO 10993-5<br>Under conditions of the<br>study, device extract is<br>cytotoxic<br>ISO 10993-11;<br>Under the<br>condition of acute<br>systemic toxicity test,<br>the test article did not<br>show acute systemic<br>toxicity in vivo. | | ISO 10993-10;<br>Under the conditions of<br>the study, not an irritant<br>or a sensitizer<br>ISO 10993-5<br>Under conditions of the<br>study, device extract is<br>cytotoxic<br>ISO 10993-11;<br>Under the conditions of<br>the study, the subject<br>showed no adverse<br>biological reaction. | | Same |
| Chemotherapy<br>Drugs Tested<br>with Minimum<br>Breakthrough<br>Detection Time | Carmustine<br>3.3 mg/ml | 22.6 Minutes | | White:18.2 Minutes | | Similar | |
| Cisplatin<br>1.0 mg/ml | >240 Minutes | | >240 Minutes | | Different | | |
| Cyclophosph | >240 Minutes | | >240 Minutes | | Same | | |

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| as Tested per<br>ASTM D 6978 | -amide<br>20.0 mg/ml | | | |
|------------------------------|------------------------------------------------|--------------|--------------|-----------|
| | Dacarbazine<br>10.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Doxorubicin<br>HCI<br>2.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Etoposide<br>20.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Fluorouracil<br>50.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | Methotrexate<br>25.0 mg/ml | >240 Minutes | / | Different |
| | Mitomycin C<br>0.5 mg/ml | >240 Minutes | / | Different |
| | Paclitaxel<br>6.0 mg/ml | >240 Minutes | >240 Minutes | Same |
| | ThioTepa<br>10.0 mg/ml | 11.0 Minutes | 57.3 Minutes | Different |
| | Vincristine<br>Sulfate<br>1.0 mg/ml | >240 Minutes | / | Different |
| | Fentanyl<br>Citrate<br>Injection<br>100mcg/2ml | >240 Minutes | >240 Minutes | Same |

# Analysis 1:

The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

# Analysis 2:

Powder Content of subject device is similar with that of the predicate, because the predicate did not publish the exact results of the powder content. But they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.

#### Analysis 3:

And Breakthrough detection times of Carmustine and Thio Tepa of subject device are different with those of the predicate. The Chemotherapy Labeling Claims has clearly defined on the labeling. So it does not raise any new safety or performance questions.

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# 8.0 Summary of Non-Clinical Testing

#### Biocompatibility Testing

The biocompatibility evaluation for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) was conducted in accordance with the following standards:

ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization.

ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

- ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity.
#### Performance Testing (Bench)

Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.

In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:

- ASTM D6124-06 (Reapproved 2017), Standard Test Method for -Residual Powder on Medical Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in -Medical Gloves.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
- -ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

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| Test<br>Method | Purpose | Acceptance Criteria | Results | |
|-----------------|-----------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|----------------|
| ASTM<br>D6319 | Physical<br>Dimensions<br>Test | Length(mm):<br>XS/S: ≥220;<br>M/L/XL: ≥230. | Length(mm):<br>XS/S: ≥220;<br>M/L/XL: ≥230. | |
| | | Width(mm):<br>XS: 70±10;<br>S: 80±10;<br>M: 95±10;<br>L: 110±10;<br>XL: 120±10. | Width(mm):<br>XS: 78-80/Pass<br>S: 83-86/Pass<br>M: 93-96/ Pass<br>L: 103-106/ Pass<br>XL:113-116/ Pass | |
| | | Finger: ≥0.05;<br>Palm: ≥0.05 | Thickness (mm):<br>Finger:<br>0.07-0.10/Pass | |
| | | | Palm:<br>0.06-0.07/Pass | |
| | | | | |
| ASTM<br>D5151 | Watertightness<br>Test for<br>Detection of<br>Holes | Meet the requirements of ASTM D5151<br>AQL 2.5 | 0/125/Pass | |
| ASTM<br>D6124 | Powder<br>Content | Meet the requirements of ASTM D6124 <<br>2.0mg | 0.16-0.30mg/Pass | |
| ASTM<br>D412 | Physical<br>properties | Before<br>Aging | Tensile<br>Strength<br>≥14MPa | 14-29 MPa/Pass |
| | | | Ultimate<br>Elongation<br>≥500% | 500-620 %/Pass |
| | | After<br>Aging | Tensile<br>Strength<br>≥14MPa | 14-23 MPa/Pass |
| | | | Ultimate<br>Elongation<br>≥400% | 405-589 %/Pass |
| ISO<br>10993-5 | Cytotoxicity | Non- In Vitro Cytotoxicity | Under conditions of<br>the study, device<br>extract is cytotoxic. | |
| ISO<br>10993-11 | Cytotoxicity | Non- acute systemic toxicity | Under conditions of<br>the study, did not<br>show acute systemic<br>toxicity in vivo / Pass | |
| ISO<br>10993-10 | Irritation | Non-irritating | Under conditions of<br>the study, not an<br>irritant. / Pass | |
| ISO<br>10993-10 | Sensitization | Non-sensitizing | Under conditions of<br>the study, not a<br>sensitizer. / Pass | |

# Table 2 - Summary of non-clinical performance testing

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# 9.0 Summary of Clinical Testing

Clinical testing is not needed for this device.

#### 10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K192954.