Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)

K211714 · Hengchang (Dongying) Medical Technology Co., Ltd. · LZA · Aug 4, 2021 · General Hospital

Device Facts

• Record ID: K211714
• Device Name: Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)
• Applicant: Hengchang (Dongying) Medical Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 4, 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 hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, powder-free, blue nitrile examination gloves; ambidextrous with beaded cuff. Used by clinicians in medical settings to prevent cross-contamination. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Output is a physical barrier; healthcare providers use gloves during patient examinations or chemotherapy drug handling. Benefits include protection against patient-to-examiner contamination and chemical exposure during drug administration. Sizes: S, M, L, XL.

Clinical Evidence

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

Technological Characteristics

Material: Nitrile. Form: Powder-free, blue, ambidextrous, beaded cuff. Standards: ASTM D6319-19 (physical properties), ASTM D5151-19 (holes), ASTM D6124-06 (powder), ASTM D6978-05 (chemotherapy permeation). Biocompatibility: ISO 10993-5, ISO 10993-10. Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hands to prevent cross-contamination between patient and examiner. Suitable for use with specific chemotherapy drugs as tested per ASTM D6978-05. Contraindicated for use with Carmustine (BCNU).

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 Powder-Free Light Blue Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs) (K201390)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 4, 2021

Hengchang (Dongying) Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161 Lujiazui East Rd., Pudong Shanghai. 200120 China

Re: K211714

Trade/Device Name: Nitrile Exam Gloves, Powder Free,Blue (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: May 25, 2021 Received: June 3, 2021

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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

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 and Part 809 ); medical device reporting (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 Murray III, 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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) k211714

#### Device Name

Nitrile Exam Gloves, Powder Free,Blue (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 hands to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|----------------------------|------------------------|----------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 23.6 Minutes |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | > 240 Minutes |
| Doxorubicin HCl | 2.0 mg/ml(2,000 ppm) | > 240 Minutes |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 Minutes |
| Methotrexate | 25 mg/ml(25,000 ppm) | > 240 Minutes |
| Mitomycin C | 0.5 mg/ml(500 ppm) | > 240 Minutes |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 Minutes |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 57.4 Minutes |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | > 240 Minutes |

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.6 Minutes Thio-Tepa 10.0 mg/ml 57.4 Minutes

Caution: Testing showed an average breakthrough time of 57.4 minutes with Thio-Tepa WARNING: Do not use with Carmustine

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 510(k) Summary (K211714)

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

## 1.0 Submitter's Information

Name: Hengchang (Dongying) Medical Technology Co.,Ltd. Address: Room 101,Building 2,No.26 Xinghe Road,Niuzhuang Town,Dongying District,Dongying City,China. Phone Number: [phone] Contact: Li Jing Date of Preparation: Aug.4,2021

## Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: [phone] Email: [e-mail]

## 2.0 Device Information

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

## 3.0_Classification

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

## 4.0 Predicate Device Information

- Manufacturer: Medline Industries, Inc. Device: Medline Powder-Free Light Blue Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs)

{5}------------------------------------------------

#### 510(k) number: K201390

## 5.0 Device Description

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. The gloves are offered in four sizes: small, medium, large, and extralarge.

## 6.0 Indication for Use_

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

These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug | Concentration | Breakthrough Detection<br>Time in Minutes |
|-------------------------------|------------------------|-------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 23.6 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | > 240 |
| Cyclophosphamide<br>(Cytoxan) | 20.0 mg/ml(20,000 ppm) | > 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml(10,000 ppm) | > 240 |
| Doxorubicin HCI | 2.0 mg/ml(2,000 ppm) | > 240 |
| Etoposide | 20.0 mg/ml(20,000 ppm) | > 240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | > 240 |
| Methotrexate | 25 mg/ml(25,000 ppm) | > 240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml(6,000 ppm) | > 240 |
| Thio Tepa | 10.0 mg/ml(10,000 ppm) | 57.4 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | > 240 |

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.6 Minutes; Thio Tepa 10.0 mg/ml 57.4Minutes.

Caution: Testing showed an average breakthrough time of 57.4 minutes with Thio-Tepa WARNING: Do not use with Carmustine

## 7.0 Technological Characteristic Comparison Table

{6}------------------------------------------------

| Item | Subject Device | Predicate Device | Remark |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | LZA,LZC | LZA,LZC | Same |
| 510(k) Reference | K211714 | K201390 | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn on the<br>examiner's hands to prevent<br>contamination between<br>patient and examiner.<br>These gloves were tested for<br>use with chemotherapy<br>drugs, per ASTM D6978-05<br>Standard Practice for<br>Assessment of Resistance<br>of Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs. | A patient examination glove<br>is a disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand to<br>prevent contamination<br>between patient and<br>examiner.<br>These gloves were tested for<br>usewith chemotherapy drugs<br>as per ASTM D6978-<br>05(2019) Standard Practice<br>for Assessment of<br>Resistance of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs. | Same |
| Powdered or<br>Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterile vs Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Color | Blue | Light Blue | Different |
| Labeling Information | Single-use indication,<br>powder free, device color,<br>device name, glove size and<br>quantity,Non-Sterile, a<br>statement of standard<br>ASTM D6978-05<br>compliance and a<br>summary of the testing<br>results. | Single-use indication, powder<br>free, device color, device<br>name, glove size and<br>quantity, Non-Sterile, a<br>statement of standard<br>ASTM D6978-05<br>compliance and a summary<br>of the testing results. | Similar |
| Dimensions - Length | Complies with ASTM<br>D6319-19:<br>S: ≥220 mm;<br>M/L/XL: ≥230 mm. | Complies with ASTM D6319-<br>19: ≥240 mm. | Similar |
| Dimensions - Width | Complies with ASTM<br>D6319-19:<br>S:80±10mm;<br>M:95±10mm;<br>L: 110±10mm; | Complies with ASTM D6319-<br>19:<br>S:85±10mm;<br>M:95±10mm;<br>L: 105±10mm; | Similar |

{7}------------------------------------------------

| | XL: 120±10mm; | | XL: 115±10mm; | | |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------|------------------|-----------|
| Dimensions -<br>Thickness | Complies with ASTM D6319-19<br>Palm:≥0.05mm<br>Finger: ≥0.05mm | | Complies with ASTM D6319-19<br>Palm:≥0.16mm<br>Finger: ≥0.14mm | | Similar |
| Physical Properties -<br>Tensile Strength | Complies with ASTM D6319-19:<br>Before Aging: ≥14MPa<br>After Aging: ≥500% | | Complies with ASTM D6319-19:<br>Before Aging: ≥17MPa<br>After Aging: ≥500% | | Similar |
| Physical Properties -<br>Elongation | Complies with ASTM D6319-19:<br>Before Aging: ≥14MPa<br>After Aging: ≥400% | | Complies with ASTM D6319-19:<br>Before Aging: ≥14MPa<br>After Aging: ≥400% | | Same |
| Freedom from Holes | Complies with ASTM D6319-19<br>and ASTM D5151-19<br>G-1, AQL 2.5 | | Complies with ASTM D6319-19<br>and ASTM D5151-19<br>G-1, AQL 2.5 | | Same |
| Powder Content | Complies with ASTM D6319-19,< 2 mg per glove | | Complies with ASTM D6319-19,< 2 mg per glove | | Same |
| Biocompatibility | Complies with ISO<br>10993-5 (2009)<br>* Under the conditions of the<br>study, the device is not<br>cytotoxic.<br>Complies with ISO<br>10993-10 (2010)<br>* Under the conditions of the<br>study, the device is a non-<br>irritant and a non-sensitizer. | | Comply with ISO10993-<br>10(2010) and ISO<br>10993-5 (2009) | | Same |
| Chemotherapy drugs tested | | Breakthrough Detection Time in Minutes | | / | |
| | | Subject Device | | Predicate Device | |
| Carmustine (BCNU), 3.3 mg/ml | | 23.6 | | 25.3 | Different |
| Cisplatin 1 mg/ml | | > 240 | | > 240 | Same |
| Cyclophosphamide 20 mg/ml | | > 240 | | > 240 | Same |
| Dacarbazine (DTIC), 10.0 mg/ml | | > 240 | | > 240 | Same |
| Doxorubicin Hydrochloride, 2.0<br>mg/ml | | > 240 | | > 240 | Same |
| Etoposide (Toposar), 20.0 mg/ml | | > 240 | | > 240 | Same |
| Fluorouracil, 50.0 mg/ml | | > 240 | | > 240 | Same |
| Methotrexate 25 mg/ml | | > 240 | | > 240 | Same |
| Mitomycin C 0.5 mg/ml | | > 240 | | > 240 | Same |
| Paclitaxel, 6.0 mg/ml | | > 240 | | > 240 | Same |
| Thiotepa, 10.0 mg/ml | | 57.4 | | 43.7 | Different |
| Vincristine Sulfate 1.0 mg/ml | | > 240 | | > 240 | Same |

{8}------------------------------------------------

## Analysis:

1. The physical properties are a little different with that of the predicate, but they all meet the requirements of ASTM D6319-19.

2. The color of the subject device is different with that of the predicate. The subject device was evaluated according to ISO 10993-1 standards, and there were no risks identified.

3: Breakthrough detection times of Carmustine (BCNU) and Thio Tepa are different. The IFU Statement has clearly defined on the labeling.

| Test Method | Purpose | Acceptance Criteria | Results |
|--------------|-----------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| ASTM D6319 | Physical<br>Dimensions Test | Length(mm):<br>S: ≥220 mm;<br>M/L/XL: ≥230 mm. | Length:>230 |
| | | Width(mm):<br>S:80±10mm;<br>M:95±10mm;<br>L: 110±10mm;<br>XL: 120±10mm. | Width:<br>S: 81-86<br>M: 93-99<br>L: 104-109<br>XL: 113-116 |
| | | Thickness (mm):<br>Finger: ≥0.05<br>Palm: ≥0.05 | |
| | | | Finger: 0.11-0.15<br>Palm: 0.08-0.15 |
| | | | Pass |
| ASTM D5151 | Watertightness<br>Test for<br>Detection of<br>Holes | Meet the requirements of<br>ASTM D5151 AQL 2.5 | 0/125 leaks<br>Pass |
| ASTM D6124 | Powder Content | Meet the requirements of<br>ASTM D6124 < 2.0mg | 0.08 (mg/glove)<br>Pass |
| ASTM D412 | Physical<br>properties | Before<br>Aging | |
| | | | Tensile Strength ≥14MPa 14.0-15.4<br>Pass |
| | | Ultimate<br>Elongation | ≥500% 506-664<br>Pass |
| | | After<br>Aging | Tensile Strength ≥14MPa 14.0-15.0<br>Pass |
| | | | Ultimate Elongation ≥400% 420-511<br>Pass |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of<br>the study, did not<br>show potential toxicity<br>to L-929 cells.<br>Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions<br>of the study, not an<br>irritant.<br>Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of<br>the study, not a<br>sensitizer.<br>Pass |

## 8.0 Summary of Non-Clinical Testing

{9}------------------------------------------------

The biocompatibility evaluation for Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) 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

### 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 D 6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

#### 9.0 Summary of Clinical Testing

Clinical testing is not needed for this device.

#### 10.0Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K201390.