Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)

K212532 · Crdlight Optoelectronic Technology Co., Ltd. · LZA · Nov 11, 2021 · General Hospital

Device Facts

• Record ID: K212532
• Device Name: Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)
• Applicant: Crdlight Optoelectronic Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Nov 11, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Disposable Powder Free Nitrile Exam Glove (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, powder-free nitrile examination gloves; ambidextrous; blue color. Used by healthcare professionals in clinical settings to prevent cross-contamination between patient and examiner. Tested for resistance to chemotherapy drug permeation per ASTM D6978-05. Output is a physical barrier; protects examiner from patient contaminants and chemotherapy agents. Not for use with Carmustine or ThioTEPA due to low breakthrough times.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993), physical properties (ASTM D6319-19), residual powder (ASTM D6124-06), freedom from holes (ASTM D5151-19), and chemotherapy permeation resistance (ASTM D6978-05).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, blue, powder-free. Standards: ASTM D6319-19 (dimensions, physical properties), ASTM D6978-05 (chemotherapy resistance), ASTM D5151-19 (holes), ISO 10993 (biocompatibility). Sterilization: Non-sterile. Connectivity: None.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Tested for use with chemotherapy drugs per ASTM D6978-05. Do not use with Carmustine or 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

• Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) (K200960)

Submission Summary (Full Text)

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November 11, 2021

CRDLight Optoelectronic Technology Co., Ltd Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K212532

Trade/Device Name: Disposable Powder Free Nitrile Exam Gloves (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 Dated: August 11, 2021 Received: August 11, 2021

Dear Ivy 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 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 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.

For 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212532

Device Name

Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)

Indications for Use (Describe)

Disposable Powder Free Nitrile Exam Glove (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Summarized in Table below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug | Concentration (mg/mL) | Breakthrough time (minutes) |
|------------------------------|-----------------------|-----------------------------|
| Carmustine (BCNU) | 3.3 mg/mL | 6.2min |
| Cisplatin | 1.0 mg/mL | >240min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/mL | >240min |
| Dacarbazine (DTIC) | 10.0 mg/mL | >240min |
| Doxorubicin HCL (Adriamycin) | 2.0 mg/mL | >240min |
| Etoposide (Toposar) | 20.0 mg/mL | >240min |
| Fluorouracil (Adrucil) | 50.0 mg/mL | >240min |
| Paclitaxel (Taxol) | 6.0 mg/mL | >240min |
| ThioTEPA | 10.0 mg/mL | 8.4min |
| Methotrexate | 25.0 mg/mL | >240min |
| Vincristine sulfate | 1.0 mg/mL | >240min |

Do not use with Carmustine or ThioTEPA.

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

# K212532

(As requirement by 21 CFR 807.92)

Date prepared: 2021-11-10

## A. Applicant:

Name: CRDLIGHT OPTOELECTRONIC TECHNOLOGY CO., LTD Address: Floor 1-5 BULIDING NO.7 & FLOOR 1-4 BUILDING NO.5 NO.18 XINYI ROAD, JIANGHAI DISTRICT, JIANGMEN GUANGDONG, CHINA Contact: Fishy liang Title: General Manager Tel: [phone] Email: [e-mail]

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

## B. Device:

Trade Name: Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) Common Name: Non-powdered patient examination glove

Regulatory Information

Classification Name: Medical Gloves with Chemotherapy Labeling Claims – Test For Use with Chemotherapy Drugs Classification: Class I Product code: LZA, LZC Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

## C. Predicate device:

## K200960

Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) Medline Industries, Inc.

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# D. Indications for use of the device:

Disposable Powder Free Nitrile Exam Glove (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug | Concentration (mg/mL) | Breakthrough time (minutes) |
|------------------------------|-----------------------|-----------------------------|
| Carmustine (BCNU) | 3.3 mg/mL | 6.2min |
| Cisplatin | 1.0 mg/mL | >240min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/mL | >240min |
| Dacarbazine (DTIC) | 10.0 mg/mL | >240min |
| Doxorubicin HCL (Adriamycin) | 2.0 mg/mL | >240min |
| Etoposide (Toposar) | 20.0 mg/mL | >240min |
| Fluorouracil (Adrucil) | 50.0 mg/mL | >240min |
| Paclitaxel (Taxol) | 6.0 mg/mL | >240min |
| ThioTEPA | 10.0 mg/mL | 8.4min |
| Methotrexate | 25.0 mg/mL | >240min |
| Vincristine sulfate | 1.0 mg/mL | >240min |

Do not use with Carmustine or ThioTEPA.

#### E. Device Description:

The Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves. The gloves are offered in sizes small, medium, large, extra large packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).

# F. Summary of Technological Characteristics

Table 2 Comparison of Proposed and Predicate Devices

| Device | Proposed Device | Predicate Device | Result |
|--------------|------------------------------------------------|--------------------------|--------|
| 510K # | K212532 | K200960 | - |
| Manufacturer | CRDLIGHT OPTOELECTRONIC TECHNOLOGY<br>CO., LTD | Medline Industries, Inc. | - |

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### CRDLIGHT OPTOELECTRONIC TECHNOLOGY CO., LTD Floor 1-5 BULIDING NO.7 & FLOOR 1-4 BUILDING NO.5 NO.18 XINYI ROAD, JIANGHAI DISTRICT, JIANGMEN GUANGDONG, CHINA

| Product Name | Disposable Powder Free Nitrile Exam Gloves<br>(Tested For Use With Chemotherapy Drugs) | Medline Nitrile Powder-Free Dark<br>Blue Examination Gloves (Tested for<br>use with Chemotherapy Drugs) | Similar |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | LZA, LZC | LZA, LZC | Same |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for<br>use | Disposable Powder Free Nitrile Exam Glove is<br>a disposable device intended for medical<br>purposes that is worn on the examiner's hand<br>to prevent contamination between patient<br>and examiner. These gloves were tested for<br>use with chemotherapy drugs. | A patient examination glove is a<br>disposable device intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. These gloves were tested for<br>use with chemotherapy drugs. | Same |
| Design<br>configurations | Blue | Dard blue | Similar |
| Material | Nitrile | Nitrile | Same |
| Size | S, M, L, XL | S, M, L, XL, XXL | Similar |
| Contact duration | Limited ≤ 24 hours | Limited ≤ 24 hours | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Singe use | Single use | Same |
| Dimensions | Complies with: ASTM D6319-19 | Complies with: ASTM D6319-10 | Similar |
| Dimensions<br>(thickness) | Complies with: ASTM D6319-19<br>Palm – 0.05mm min.<br>Finger – 0.05mm min. | Complies with: ASTM D6319-10<br>Palm - 0.05mm min.<br>Finger - 0.05mm min. | Similar |
| Physical<br>properties | Complies with: ASTM D6319-19<br>Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Complies with: ASTM D6319-10<br>Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Similar |
| Freedom from<br>holes | Complies with: ASTM D6319-19 and ASTM<br>D5151-19<br>G-1, AQL 2.5 | Complies with: ASTM D6319-10 and<br>ASTM D5151-06<br>G-1, AQL 1.5 | Different |
| Powder free | Yes | Yes | Same |
| Residual Powder | Complies with: ASTM D6319-19<br><2mg per glove | Complies with: ASTM D6319-10<br><2mg per glove | Similar |
| Biocompatibility | Complies with ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer | Complies with AAMI/ANSI/ISO<br>10993-10:<br>Not a skin irritant | Similar |

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### CRDLIGHT OPTOELECTRONIC TECHNOLOGY CO., LTD Floor 1-5 BULIDING NO.7 & FLOOR 1-4 BUILDING NO.5 NO.18 XINYI ROAD. JIANGHAI DISTRICT, JIANGMEN GUANGDONG, CHINA

| ISO 10993-05: cytotoxicity potential | | | Not a skin sensitizer | | Similar | |
|---------------------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------|------------------------------------------------------|----------------------------------------|----------------------------|-------------------|
| ISO 10993-11: | | | AAMI/ANSI/ISO 10993-05<br>ISO 10993-11:<br>Non-Toxic | | | |
| | Non-Toxic | | | | | |
| Chemotherapy<br>Drugs Tested<br>with Minimum<br>Breakthrough<br>Detection Time<br>as tested per<br>ASTM D6978 | Chemotherapy Drug | Concentration<br>(mg/mL) | Breakthrough time<br>(minutes) | Chemotherapy Drug | Concentration | Breakthrough time |
| | Carmustine<br>(BCNU) | 3.3 mg/mL | 6.2min | Carmustine<br>(BCNU) | 3.3 mg/ml<br>(3,300 ppm) | 12.4 minutes |
| | Cisplatin | 1.0 mg/mL | >240min | Cisplatin | 1.0 mg/ml<br>(1,000 ppm) | >240 minutes |
| | Cyclophosphamide<br>(Cytoxan) | 20.0 mg/mL | >240min | Cyclophosphamide<br>(Cytoxan) | 20.0 mg/ml<br>(20,000 ppm) | >240 minutes |
| | Dacarbazine (DTIC) | 10.0 mg/mL | >240min | Dacarbazine<br>(DTIC) | 10.0 mg/ml<br>(10,000 ppm) | >240 minutes |
| | Doxorubicin HCL<br>(Adriamycin) | 2.0 mg/mL | >240min | Doxorubicin<br>Hydrochloride | 2.0 mg/ml<br>(2,000 ppm) | >240 minutes |
| | Etoposide<br>(Toposar) | 20.0 mg/mL | >240min | Etoposide<br>(Toposar) | 20.0 mg/ml<br>(20,000 ppm) | >240 minutes |
| | Fluorouracil<br>(Adrucil) | 50.0 mg/mL | >240min | Fluorouracil | 50.0 mg/ml<br>(50,000 ppm) | >240 minutes |
| | Paclitaxel (Taxol) | 6.0 mg/mL | >240min | Methotrexate | 25 mg/ml<br>(25,000 ppm) | >240 minutes |
| | ThioTEPA | 10.0 mg/mL | 8.4min | Mitomycin C | 0.5 mg/ml (500 ppm) | >240 minutes |
| | Methotrexate | 25.0 mg/mL | >240min | Paclitaxel (Taxol) | 6.0 mg/ml<br>(6,000 ppm) | >240 minutes |
| | Vincristine sulfate | 1.0 mg/mL | >240min | Thio Tepa | 10.0 mg/ml<br>(10,000 ppm) | 27.4 minutes |
| | | | | Vincristine Sulfate<br>(Oncovin) | 1.0 mg/ml<br>(1,000 ppm) | >240 minutes |
| | Do not use with Carmustine or ThioTEPA. | | | Do Not Use with Carmustine or Thiotepa | | |

## G. Summary of Non-Clinical Testing

#### > Biocompatibility

Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to evaluated the biocompatibility of Disposable Powder Free Nitrile Exam Gloves:

- ISO 10993-10: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- · ISO 10993-05: Cytotoxicity
- · ISO 10993-11: Systemic Toxicity

#### A Performance Testing

Physical performance testing of the proposed device were conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application 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.

To summarize, the performance testing of the subject device were conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:

- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves

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### CRDLIGHT OPTOELECTRONIC TECHNOLOGY CO., LTD Floor 1-5 BULIDING NO.7 & FLOOR 1-4 BUILDING NO.5 NO.18 XINYI ROAD, JIANGHAI DISTRICT, JIANGMEN GUANGDONG, CHINA

- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
• ASTM D6978-05 (Reapproved 2019)Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

| Test Method | Purpose | Acceptance Criteria | Results | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Dimensions (width)<br>(thickness) | The purpose of the<br>test is to evaluate<br>the physical<br>dimension of the<br>glove | Width 70mm min<br>Length 220mm min<br>Palm – 0.05mm min.<br>Finger–0.05mm min. | Pass<br>76mm min width<br>229mm min length<br>Pass<br>Palm – 0.07mm min.<br>Finger–0.08mm min | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Physical properties | The purpose of the<br>test is to evaluate<br>the tensile strength<br>and ultimate<br>elongation before<br>and after aging | Tensile Strength:<br>Before Aging ≥ 14 MPa, min.<br>After Aging ≥ 14 MPa, min.<br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Pass<br>Tensile Strength:<br>Before Aging 15.08 MPa, min.<br>After Aging 14.87 MPa, min.<br>Elongation:<br>Before Aging 570%, min.<br>After Aging 529%, min. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Freedom from holes | The purpose of the<br>test is to detect<br>holes in the gloves | No leakage at<br>sampling level of G-1,<br>AQL 2.5 | Pass<br>No leakage, 80 of 80 passed of each size | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Residual Powder | The purpose of the<br>test is to detect the<br>powder residue in<br>the glove | <2mg per glove | Pass<br>Max. 0.52 mg per glove | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Chemotherapy<br>Drugs Tested with<br>Minimum<br>Breakthrough<br>Detection Time as<br>tested per ASTM<br>D6978 | The purpose of the<br>test is to test the<br>resistance of<br>medical gloves to<br>permeation by<br>chemotherapy drugs | >240min | Pass Chemotherapy Drug Concentration (mg/mL) Breakthrough time (minutes) Cisplatin 1.0 mg/mL >240min Cyclophosphamide (Cytoxan) 20.0 mg/mL >240min Dacarbazine (DTIC) 10.0 mg/mL >240min Doxorubicin HCL (Adriamycin) 2.0 mg/mL >240min Etoposide (Toposar) 20.0 mg/mL >240min Fluorouracil (Adrucil) 50.0 mg/mL >240min Paclitaxel (Taxol) 6.0 mg/mL >240min Methotrexate 25.0 mg/mL >240min Vincristine sulfate 1.0 mg/mL >240min | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

### H. Clinical Test Conclusion

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No clinical study is included in this submission.

#### l. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Disposable Powder Free Nitrile Exam Glove (Tested For Use With Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K200960.