Disposable Medical Nitrile Examination Gloves (Non sterile)

K212639 · Jiangsu Nanfang Medical Co., Ltd. · LZC · Dec 8, 2021 · General Hospital

Device Facts

• Record ID: K212639
• Device Name: Disposable Medical Nitrile Examination Gloves (Non sterile)
• Applicant: Jiangsu Nanfang Medical Co., Ltd.
• Product Code: LZC · General Hospital
• Decision Date: Dec 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Disposable Medical Nitrile Examination Gloves (Non sterile) are 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 nitrile examination gloves; non-sterile; blue; powder-free. Worn by healthcare examiners to provide barrier protection against patient-to-examiner contamination. Tested for permeation resistance against various chemotherapy drugs per ASTM D6978-05(2019). Device provides physical barrier; does not involve electronic input/output or software. Used in clinical settings. Benefits include protection against biological contaminants and specific hazardous chemotherapy agents.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included physical dimensions, tensile strength, elongation (before/after aging), freedom from holes (ASTM D5151), residual powder (ASTM D6124), chemotherapy drug permeation (ASTM D6978), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Nitrile compound; powder-free; blue; finger-textured. Dimensions and physical properties per ASTM D6319-19. Chemotherapy resistance per ASTM D6978-05(2019). Biocompatibility per ISO 10993-5 and ISO 10993-10. Non-sterile.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hands to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs per ASTM D6978-05(2019).

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 Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (K172525)

Submission Summary (Full Text)

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December 8, 2021

Jiangsu Nanfang Medical Co., Ltd Johnson Liu Consultant CNMED Consultant 31 Archer St Upper MT Gravatt, QLD 4122 Australia

Re: K212639

Trade/Device Name: Disposable Medical Nitrile Examination Gloves (Non sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZC, LZA Dated: November 8, 2021 Received: November 12, 2021

Dear Johnson Liu:

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) K212639

#### Device Name

Disposable Medical Nitrile Examination Gloves (Non Sterile)

#### Indications for Use (Describe)

Disposable Medical Examination Nitrile Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019):

The following drugs had NO breakthrough detected up to 240 minutes:

| Busulfan,<br>6 mg/ml (6,000 ppm) | Fluorouracil,<br>50.0 mg/ml (50,000 ppm) |
|--------------------------------------------------------|---------------------------------------------|
| Carboplatin /Paraplatin,<br>10 mg/ml (10,000 ppm) | Ifosfamide,<br>50 mg/ml (50,000 ppm) |
| Cisplatin,<br>1.0 mg/ml (1,000 ppm) | Mechlorethamine HCI,<br>1 mg/ml (1,000 ppm) |
| Cyclophosphamide (Cytoxan),<br>20.0 mg/ml (20,000 ppm) | Methotrexate,<br>25 mg/ml (25,000 ppm) |
| Cytarabine HCI,<br>100 mg/ml (100,000 ppm) | Mitomycin,<br>0.5 mg/ml (500 ppm) |
| Dacarbazine,<br>10.0 mg/ml (10,000 ppm) | Mitoxantrone,<br>2 mg/ml (2,000 ppm) |
| Docetaxel,<br>10 mg/ml (10,000 ppm) | Paclitaxel,<br>6.0 mg/ml (6,000 ppm) |
| Doxorubicin HCI,<br>2.0 mg/ml (2,000 ppm) | Vincristine Sulfate,<br>1 mg/ml (1,000 ppm) |
| Etoposide,<br>20.0 mg/ml (20,000 ppm) | |

Please note that the following drug has low permeation times of less than 60 minutes:

Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes

ThioTepa10.0 mq/ml (10.000 ppm),35.7 minutes

WARNING: Do not use Carmustine and 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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Image /page/3/Picture/1 description: The image is a logo for Miao Shou. The logo is a green circle with a green flower inside. The flower has a hand in the center. The words "Miao Shou" are written in English and Chinese on either side of the flower.

# 510(K) Summary

# Disposable Medical Nitrile Examination Gloves (Non sterile)

Preparation Date: November 8th, 2021

#### 1. SUBMITTER

Company Name: Jiangsu Nanfang Medical Co.,Ltd Company Address: No.1 Guoxiang RD. Wujin Economic Development Zone, WUJIN CHANGZHOU Jiangsu, CN 213149

Contact Person: Johnson Liu Telephone Number: [phone] Email: [e-mail]

### 2. NAME OF THE DEVICE

Trade Name / Proprietary Name: Disposable Medical Nitrile Examination Gloves (Non sterile) Device Name: Disposable Medical Examination Nitrile Gloves Device Classification Name: Patient Examination Gloves Device Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZC LZA

## 3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE

Predicate Device: K172525 Applicant: Central Medicare Sdn. Bhd Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Device Classification Name: Patient Examination Gloves Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZC LZA Review Panel: General Hospital

### 4. DEVICE DESCRIPTION

The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile), a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and tested as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

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Image /page/4/Picture/1 description: The image is a logo for a company called "Miao Shou". The logo is a green circle with a green flower in the center. The flower has a hand in the middle of it. The words "Miao Shou" are written in English and Chinese on either side of the flower. There is a registered trademark symbol in the upper right corner of the logo.

# 5. INDICATIONS for USE OF THE DEVICE

Disposable Medical Nitrile Examination Gloves (Non sterile) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019):

The following drugs had NO breakthrough detected up to 240 minutes:

| Busulfan,<br>6 mg/ml (6,000 ppm) | Fluorouracil,<br>50.0 mg/ml (50,000 ppm) |
|--------------------------------------------------------|---------------------------------------------|
| Carboplatin /Paraplatin,<br>10 mg/ml (10,000 ppm) | Ifosfamide,<br>50 mg/ml (50,000 ppm) |
| Cisplatin,<br>1.0 mg/ml (1,000 ppm) | Mechlorethamine HCI,<br>1 mg/ml (1,000 ppm) |
| Cyclophosphamide (Cytoxan),<br>20.0 mg/ml (20,000 ppm) | Methotrexate,<br>25 mg/ml (25,000 ppm) |
| Cytarabine HCI,<br>100 mg/ml (100,000 ppm) | Mitomycin,<br>0.5 mg/ml (500 ppm) |
| Dacarbazine,<br>10.0 mg/ml (10,000 ppm) | Mitoxantrone,<br>2 mg/ml (2,000 ppm) |
| Docetaxel,<br>10 mg/ml (10,000 ppm) | Paclitaxel,<br>6.0 mg/ml (6,000 ppm) |
| Doxorubicin HCI,<br>2.0 mg/ml (2,000 ppm) | Vincristine Sulfate,<br>1 mg/ml (1,000 ppm) |
| Etoposide,<br>20.0 mg/ml (20,000 ppm) | |

Please note that the following drug has low permeation times of less than 60 minutes:

Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes

ThioTepa10.0 mg/ml (10,000 ppm),35.7 minutes

WARNING: Do not use Carmustine and Thiotepa

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# 6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE DEVICES

| | DEVICE PERFORMANCE | | | |
|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|------------|
| CHARACTERISTICS | SUBJECT | PREDICATE | REMARKS | |
| 510(k) Number | K212639 | K172525 | - | |
| Device Name | Disposable Medical Nitrile<br>Examination Gloves (Non sterile) | Blue Non Sterile Powder Free<br>Nitrile Examination Gloves<br>Tested for Use with<br>Chemotherapy Drugs | - | |
| Product Code | LZC LZA | LZC LZA | Same | |
| Indications for Use | Disposable Medical Nitrile<br>Examination Gloves (Non sterile) are<br>a disposable device intended for<br>medical purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. | Blue Non Sterile Powder Free<br>Nitrile Examination Gloves<br>Tested for Use with<br>Chemotherapy Drugs is a<br>disposable device intended for<br>medical purposes that is worn<br>onthe examiner's hands to<br>prevent contamination between<br>patient and examiner. | Same | |
| Chemotherapy Drugs Permeation<br>Claim | Busulfan, Carboplatin /Paraplatin,<br>Cisplatin, Cyclophosphamide<br>(Cytoxan), Cytarabine HCI,<br>Dacarbazine, Docetaxel, Doxorubicin<br>HCI, Etoposide, Fluorouracil,<br>Ifosfamide, Mechlorethamine HCI,<br>Methotrexate, Mitomycin,<br>Mitoxantrone, Paclitaxel, Vincristine<br>Sulfate. | Fluorouracil, Etoposide<br>(Toposar), Cyclophosphamid<br>(Cytoxan), Carmustine<br>(BCNU), Thiotepa, Paclitaxel<br>(Taxol), Doxorubicin<br>Hydrochloride, Dacarbazine<br>(DTIC), Cisplatin,<br>Ifosfamide, Mitoxantrone,<br>Vincristine Sulfate | Equivalent | |
| Materials of Use<br>(ASTM<br>D6910/D6910M-19) | Nitrile compound | Nitrile compound | Same | |
| Color | Blue | Blue | Same | |
| Texture | Finger Textured | Finger Textured | Same | |
| Size<br>(ASTM D6319-19) | Small, Medium, Large, | Small, Medium, Large,<br>Extra Large | Same | |
| Sterilization | Non-sterile | Non-sterile | Same | |
| Usage | Single usage | Single usage | Same | |
| Dimensions<br>(ASTM D6319-19) | Length Min. 220 min Width Min<br>80+/-10 mm (for small size)<br>Length Min. 230 min Width Min<br>95+/-10 mm (for medium size)<br>Length Min. 230 min Width Min<br>110+/-10 mm (for large size) | Length Min. 230 min Width Min<br>80+/-10 mm (for small size)<br>Length Min. 230 min Width Min<br>95+/-10 mm (for medium size)<br>Length Min. 230 min Width Min<br>110+/-10 mm (for large size) | Equivalent | |
| | | | | |
| Physical Properties<br>(ASTM D6319-19) | Before Aging<br>Tensile Strength<br>Min 14 Mpa Ultimate Elongation<br>Min 500%<br>After Aging<br>Tensile Strength<br>Min 14 Mpa Ultimate Elongation<br>Min 400% | | Same | |
| Thickness<br>(ASTM D6319-19) | Palm min 0.05 mm | Palm min 0.08 mm | Equivalent | |
| | Finger min 0.05 mm | Finger min 0.10 mm | | |
| Powder Free<br>(ASTM D6319-19) | <2 mg/glove<0.52 mg/glove | | Equivalent | |
| Freedom from Holes<br>(Water Tight -1000 ml) -<br>ASTM D6319-19 (Cross<br>Reference D5151) | AQL 2.5 | AQL 2.5 | Same | |
| | Passed | Passed | | |
| Biocompatibility -<br>SKIN SENSITIZATION -<br>ISO 10993-10: 2010 (E) | Under the conditions of study not a<br>sensitizer | Under the conditions of study<br>not a sensitizer | Same | |
| Biocompatibility -<br>SKIN IRRITATION - ISO<br>10993-10: 2010 (E) | Under the conditions of<br>the study not an irritant | Under the conditions of<br>the study not an irritant | Same | |
| Biocompatibility - IN<br>VITRO CYTOTOXICITY<br>- ISO<br>10993-5: 2009(E) | | Under the conditions of the<br>cytotoxicity study, mild<br>Systemic cytotoxicity (Grade 2)<br>observed. It complied with the<br>criteria in ISO 10993-5:2009. | No information provided | Equivalent |
| Manufacturer(s) | Jiangsu Nanfang Medical Co.,Ltd | Central Medicare Sdn. Bhd | --- | |

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There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-19 and tested for the use with chemotherapy drugs.

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# 7. NON-CLINICAL TESTING SUMMARY

# PERFORMANCE DATA

| Test Method | Purpose | Acceptance Criteria | Result |
|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASMT D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application - Physical<br>Dimensions Test | To determine the<br>width, length, and<br>thickness of the<br>gloves | Size Small | Width:<br>82mm-89mm |
| | | Width:<br>$80 mm \pm 10mm$ | Length<br>230mm (Minimum) |
| | | Length:<br>220 mm (Minimum) | Thickness<br>Finger<br>0.12mm (Minimum) |
| | | Thickness:<br>Finger -0.05 mm<br>(Minimum)<br>Palm -0.05 mm<br>(Minimum) | Palm<br>0.08mm (Minimum) |
| | | | Passed |
| | | Size Medium | Width:<br>91mm-96mm |
| | | Width:<br>$95 mm \pm 10mm$ | Length<br>240mm (Minimum) |
| | | Length:<br>230 mm (Minimum) | Thickness<br>Finger<br>0.13mm (Minimum) |
| | | Thickness:<br>Finger -0.05 mm<br>(Minimum)<br>Palm -0.05 mm<br>(Minimum) | Palm<br>0.08mm (Minimum) |
| | | | Passed |
| | | Size Large | Width:<br>111mm-113mm |
| | | Width:<br>$110 mm \pm 10mm$ | Length<br>240mm (Minimum) |
| | | Length:<br>230 mm (Minimum) | Thickness<br>Finger<br>0.13mm (Minimum) |
| | | Thickness:<br>Finger -0.05 mm<br>(Minimum<br>Palm -0.05 mm<br>(Minimum) | Palm<br>0.09mm (Minimum) |
| | | | Passed |
| ASMT D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application - Physical<br>Requirements Test | To determine the<br>tensile strength and<br>ultimate elongation<br>before and after<br>acceleration aging | Before Acceleration Aging:<br>Tensile Strength (MPa):<br>14 (Minimum)<br>Ultimate Elongation (%):<br>500 (Minimum)<br>After Acceleration Aging:<br>Tensile Strength (MPa):<br>14 (Minimum)<br>Ultimate Elongation (%):<br>400 (Minimum) | Before Acceleration Aging:<br>Tensile Strength (MPa):<br>29 (Minimum)<br>Ultimate Elongation (%):<br>515 (Minimum)<br>After Acceleration Aging:<br>Tensile Strength (MPa):<br>26 (Minimum)<br>Ultimate Elongation (%):<br>511 (Minimum) |
| ASTM D6319-19<br>(ASTM D5151-11)<br>Standard Test Method<br>for Detection of Holes in<br>Medical Gloves | To determine the<br>holes in the gloves | (Mean)<br>AQL 2.5 | Passed |
| ASMT D6319-19<br>(ASTM D6124-11)<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | To determine the<br>residual powder in<br>the gloves | $≤$ 2.0 mg/glove | 0.2 mg/glove, Passed |

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## Testing with Chemotherapy Drugs as per ASTM D6978-05.

| Busulfan,<br>6 mg/ml (6,000 ppm) | Fluorouracil,<br>50.0 mg/ml (50,000 ppm) |
|--------------------------------------------------------|---------------------------------------------|
| Carboplatin /Paraplatin,<br>10 mg/ml (10,000 ppm) | Ifosfamide,<br>50 mg/ml (50,000 ppm) |
| Cisplatin,<br>1.0 mg/ml (1,000 ppm) | Mechlorethamine HCI,<br>1 mg/ml (1,000 ppm) |
| Cyclophosphamide (Cytoxan),<br>20.0 mg/ml (20,000 ppm) | Methotrexate,<br>25 mg/ml (25,000 ppm) |
| Cytarabine HCI,<br>100 mg/ml (100,000 ppm) | Mitomycin,<br>0.5 mg/ml (500 ppm) |
| Dacarbazine,<br>10.0 mg/ml (10,000 ppm) | Mitoxantrone,<br>2 mg/ml (2,000 ppm) |
| Docetaxel,<br>10 mg/ml (10,000 ppm) | Paclitaxel,<br>6.0 mg/ml (6,000 ppm) |
| Doxorubicin HCI,<br>2.0 mg/ml (2,000 ppm) | Vincristine Sulfate,<br>1 mg/ml (1,000 ppm) |
| Etoposide,<br>20.0 mg/ml (20,000 ppm) | |

The following drugs had NO breakthrough detected up to 240 minutes:

The drugs have low permeation times of less than 60 minutes:

Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes

ThioTepa10.0 mg/ml (10,000 ppm),35.7 minutes

#### BIO-COMPATIBILITY DATA

| Test Method | Purpose | Acceptance Criteria | Result |
|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------|
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To determine the potential of the material under test to produce skin irritation in rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To determine the skin sensitization potential of the material both in terms of induction and elicitation in guinea pigs. | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. |
| ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | To evaluate the in vitro cytotoxic potential of the test item (both inner and outer surface) Extracts in L-929 mouse fibroblasts cells using elution method | Under the conditions of study, no more than grade 2 cytotoxic reaction | Slight (Grade 1) cytotoxicity reaction observed. |

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## 8. CLINICAL TESTING SUMMARY

Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

# 9. CONCLUSION

The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(k) submission, the Disposable Medical Nitrile Examination Gloves (Non Sterile) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K172525- Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs.