Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs

K211220 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · LZA · Jul 22, 2021 · General Hospital

Device Facts

• Record ID: K211220
• Device Name: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs
• Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jul 22, 2021
• 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 to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 58.3minutes

Device Story

Disposable, non-sterile, powder-free nitrile examination gloves; ambidextrous; beaded cuff; blue/blue-violet color; inner colloidal oatmeal USP coating. Used by healthcare examiners to prevent cross-contamination. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05 (2019). Provides barrier protection during clinical examinations.

Clinical Evidence

No clinical data. Bench testing only, including ASTM D5151 (water leak), ASTM D3767 (dimensions), ASTM D412/D573 (physical properties), ASTM D6124 (residual powder), ASTM D6978-05 (chemotherapy permeation), and ISO 10993-10/11 (biocompatibility/toxicity).

Technological Characteristics

Material: Nitrile; powder-free; inner coating: colloidal oatmeal USP. Dimensions/properties comply with ASTM D6319-19. Non-sterile. Ambidextrous, beaded cuff. Sizes: S, M, L, XL. Chemotherapy permeation tested per ASTM D6978-05.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand to prevent cross-contamination between patient and examiner. Suitable for use with specific chemotherapy drugs.

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

• Medline Green Ambidextrous Power-Free Nitrile Examination Gloves With Colloidal Oatmeal USP (Tested For Use With Chemotherapy Drugs) (K192315)

Submission Summary (Full Text)

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July 22, 2021

Guangdong Kingfa Sci. & Tech. Co., Ltd. Xiaoge Yu Manager No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, Guangdong 511545 China

Re: K211220

Trade/Device Name: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: April 16, 2021 Received: April 23, 2021

Dear Xiaoge Yu:

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.

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) K211220

#### Device Name

Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs

#### Indications for Use (Describe)

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

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 58.3minutes

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

| <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|--------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# 510(k) Summary K211220

## I. Submitter

GUANGDONG KINGFA SCI. & TECH.CO., LTD. No.28 Delong Ave., Shijiao Town, Qingcheng District, Qingyuan, Guangdong, China

Contact person: Xiaoge Yu Position: Manager Tel.: [phone] E-mail: [e-mail]

Preparation date: April. 03, 2021

## US Agent

Jeff Zhang Ucl-Reg Service Inc 602 Rockwood Rd Wilmington, DE US 19802 Phone: [phone] Email: [e-mail]

### II. Proposed Device

| Device Trade Name | Nitrile Patient Examination Gloves Blue Tested For Use With<br>Chemotherapy Drugs<br>Nitrile Patient Examination Gloves Blue Violet Tested For Use<br>With Chemotherapy Drugs |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Patient Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LZA, LZC,OPJ |
| Review Panel | General Hospital |

### III. Predicate Devices

| 510(k) Number: | K192315 |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name: | Medline Green Ambidextrous Power-Free Nitrile Examination<br>Gloves With Colloidal Oatmeal USP (Tested For Use With<br>Chemotherapy Drugs) |
| Common name: | Patient Examination Glove |

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Classification: Class I

Product Code: LZA. LZC.OPJ Manufacturer Medline Industries, Inc.

### IV. Device description

Power-Free Nitrile Examination Gloves(Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, Blue/Blue violet colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in four sizes, small, medium, large and extra-large.

The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).

### V. Indication for use

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

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 58.3minutes

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## VI. Comparison of technological characteristics with the predicate devices Table 1 Comparison of Natural Rubber Surgical Gloves

| Item | Proposed device<br>(K211220) | Predicate device<br>(K192315) | Discussion |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Product name | Nitrile Patient<br>Examination Gloves Blue<br>Tested For Use With<br>Chemotherapy Drugs<br>Nitrile Patient<br>Examination Gloves Blue<br>Violet Tested For Use<br>With Chemotherapy<br>Drugs | Medline Green<br>Ambidextrous<br>Powder-Free Nitrile<br>Examination<br>Gloves with Colloidal<br>Oatmeal USP (Tested<br>for use with<br>Chemotherapy Drugs) | - |
| Product Code | LZA, LZC,OPJ | LZA, LZC,OPJ | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | Class I | Class I | Same |
| Powder free | Yes | Yes | Same |
| Indication for use | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested<br>for use with<br>Chemotherapy drugs and<br>Fentanyl Citrate as per<br>ASTM D6978-05<br>(Reapproved<br>2019) Standard Practice<br>for Assessment of<br>Medical Gloves of<br>Permeation by<br>Chemotherapy Drugs | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were<br>tested for use with<br>Chemotherapy drugs<br>and Fentanyl Citrate as<br>per ASTM D6978-05<br>(Reapproved<br>2013) Standard Practice<br>for Assessment of<br>Medical Gloves of<br>Permeation by<br>Chemotherapy Drugs | Similar* |
| Main Material | Powder-Free Nitrile | Powder-Free Nitrile | Same |
| Color | Blue, Blue violet | Blue | Similar* |
| Size | small, medium, large,<br>x-large | x-small, small, medium,<br>large, x-large | Similar* |
| Dimensions –<br>Length | Complies with ASTM<br>D6319-10<br>S (220mm min)<br>M (230mm min)<br>L (230mm min)<br>XL (230mm min) | Complies with ASTM<br>D6319-10<br>220mm min. | Similar* |
| Dimensions -<br>Width | Complies with ASTM<br>D6319-10<br>Small (80±10mm)<br>Medium (95±10mm)<br>Large (110±10mm)<br>X large (120±10mm) | Complies with ASTM<br>D6319-10<br>X-small - 70±10mm<br>Small - 80±10mm<br>Medium - 95±10mm<br>Large - 110±10mm<br>X-large - 120±10mm | Similar* |
| Dimensions –<br>Thickness | Complies with:<br>ASTM D6319-10<br>Palm: 0.05mm min<br>Finger: 0.11mm min | Complies with:<br>ASTM D6319-10<br>Palm - 0.05mm min.<br>Finger – 0.05mm min. | Similar* |
| Physical<br>Properties | Complies with:<br>ASTM D6319-10<br>minimum:<br>Tensile Strength:<br>Before Aging $≥$ 14 MPa,<br>min.<br>After Aging $≥$ 14 MPa,<br>min. | Complies with:<br>ASTM D6319-10<br>minimum:<br>Tensile Strength:<br>Before Aging $≥$ 14<br>MPa, min.<br>After Aging $≥$ 14 MPa,<br>min. | Same |
| | Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Elongation:<br>Before Aging 500%,<br>min.<br>After Aging 400%, min. | Same |
| Freedom from<br>Holes | Complies with ASTM<br>D6319-10 and ASTM<br>D5151-06 G-1, AQL 1.5 | Complies with:<br>ASTM D6319-10 and<br>ASTM D5151-06 G-1,<br>AQL 1.5 | Same |
| Powder or<br>Powder-Free | Powder-Free | Powder-Free | Same |
| Residual<br>Powder | Complies with:<br>ASTM D6319-10<br><2mg per glove | Complies with:<br>ASTM D6319-10<br><2mg per glove | Same |
| Contact<br>Durations | Limited <24 hours | Limited <24 hours | Same |
| Biocompatibility | AAMI/ANSI/ISO<br>10993-10:<br>Not a skin irritant<br>Not a skin sensitizer<br>At the neat extraction, the<br>test article is considered<br>cytotoxic, but the acute<br>systemic toxicity results<br>demonstrate the device<br>will not cause a systemic<br>effect. | AAMI/ANSI/ISO<br>10993-10:<br>Not a skin irritant<br>Not a skin sensitizer<br>At the neat extraction, the<br>test article is<br>considered cytotoxic, but<br>the acute systemic<br>toxicity results<br>demonstrate the device<br>will not cause a systemic<br>effect. | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Rx Only or OTC | Over the Counter | Over the Counter | Same |
| Tested<br>Chemotherapy<br>Drugs | Carmustine (BCNU) 3.3<br>mg/ml 65.3 minutes<br>Cisplatin 1.0 mg/ml >240<br>minutes<br>Cyclophosphamide<br>(Cytoxan) 20.0<br>mg/ml >240 minutes<br>Dacarbazine (DTIC)10.0<br>mg/ml >240 minutes<br>Doxorubicin<br>Hydrochloride 2.0<br>mg/ml >240 minutes<br>Etoposide (Toposar) 20.0<br>mg/ml >240 minutes<br>Fluorouracil 50.0<br>mg/ml >240 minutes<br>Paclitaxel (Taxol) 6.0<br>mg/ml >240 minutes<br>Thiotepa 10.0 mg/ml<br>58.3minutes | Carmustine (BCNU) 3.3<br>mg/ml 65.3 minutes<br>Cisplatin 1.0<br>mg/ml >240 minutes<br>Cyclophosphamide<br>(Cytoxan) 20.0<br>mg/ml >240 minutes<br>Dacarbazine (DTIC)10.0<br>mg/ml >240 minutes<br>Doxorubicin<br>Hydrochloride 2.0<br>mg/ml >240 minutes<br>Etoposide (Toposar)<br>20.0 mg/ml >240<br>minutes<br>Fluorouracil 50.0<br>mg/ml >240 minutes<br>Paclitaxel (Taxol) 6.0<br>mg/ml >240 minutes<br>Thiotepa 10.0 mg/ml<br>58.3minutes<br>Other Drugs | Similar<br>The Tested<br>Chemother<br>apy Drugs<br>of<br>Predicate<br>device is<br>more than<br>Proposed<br>device |

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*As above comparison, the difference in the dimensions and reference standard version of the subject and predicate device does not raise additional questions for safety and effectiveness of the device. The biocompatibility test and performance test of the subject devices have been performed on the final finished device. The test results shows pass the requirements.

# VII. Non-Clinical Testing

Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.

- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for ● Medical Application
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions ●
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves .
- ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical . Gloves
- ASTM D573-04(2019), Standard Test Method for Rubber—Deterioration in an Air ● Oven
- ASTM D412-16, Standard Test Methods for Vulcanized Rubber and ● Thermoplastic Elastomers-Tension
- ASTM D6978-05(2019), Standard Practice for Assessment of Resistance of . Medical Gloves to Permeation by Chemotherapy Drugs
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For ● Irritation And Skin Sensitization.
- ISO 10993-11:2017, Biological evaluation of medical devices Part11:Tests for . Systemic Toxicity

| Test Method | Purpose | Acceptance Criteria | Results |
|--------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------|
| ASTM D5151 | Water Leak Test | The gloves shall be free<br>from hole when tested in<br>accordance with the<br>method given in ASTM<br>D5151. | pass |
| ASTM D3767 | Dimension | The actual measured<br>dimension of the gloves<br>shall be meet the stated<br>tolerance in Table 2 of<br>the ASTM D 6319-19 | pass |
| Before aging ASTM<br>D412,<br>After aging ASTM<br>D573 | Physical Properties<br>Tensile Strength,<br>Ultimate Elongation | Before and after<br>accelerated aging, the<br>gloves shall conform to<br>the physical<br>requirements in the | pass |

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| | | Table 3 of ASTM 6319-<br>19 | |
|-------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| ASTM D6124 | Residual Powder<br>Content<br>Powder amount | The powder residue<br>content shall be not<br>more than 2mg per<br>gloves. | pass |
| ASTM D6978-05 | Chemotherapy<br>Drugs | Carmustine (BCNU) 3.3<br>mg/ml 65.3 minutes<br>Cisplatin 1.0 mg/ml >240<br>minutes<br>Cyclophosphamide<br>(Cytoxan) 20.0 mg/ml<br>>240 minutes<br>Dacarbazine (DTIC)10.0<br>mg/ml >240 minutes<br>Doxorubicin<br>Hydrochloride 2.0 mg/ml<br>>240 minutes<br>Etoposide (Toposar)<br>20.0 mg/ml >240<br>minutes<br>Fluorouracil 50.0 mg/ml<br>>240 minutes<br>Paclitaxel (Taxol) 6.0<br>mg/ml >240 minutes<br>Thiotepa 10.0 mg/ml<br>58.3minutes | pass |
| ISO 10993-10:2010 | Skin irritation | non-sensitizing | pass |
| ISO 10993-10:2010 | Skin Sensitization | non-irritating | pass |
| ISO 10993-11:2017 | Acute Systemic<br>Toxicity | No acute system toxicity | pass |

# VIII. Clinical Testing

No clinical study is included in this submission.

# IX. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.