Nitrile Examination Gloves

K212551 · Anhui Fine Glove Medical Technology Co., Ltd. · LZA · Nov 5, 2021 · General Hospital

Device Facts

• Record ID: K212551
• Device Name: Nitrile Examination Gloves
• Applicant: Anhui Fine Glove Medical Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Nov 5, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Nitrile Examination Gloves are single-use, non-sterile, blue, powder-free nitrile gloves. Worn by healthcare examiners to provide a barrier against cross-contamination between patient and examiner. Device is manufactured from nitrile compound and features finger-textured surfaces. Used in clinical or general settings; operated by healthcare professionals or patients (OTC). Output is a physical barrier; healthcare providers use the gloves during examinations to maintain hygiene and prevent pathogen transmission. Benefits include protection against contamination during medical procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D6319-19 for physical dimensions, tensile strength, elongation, hole detection (AQL 2.5), and residual powder. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin irritation/sensitization).

Technological Characteristics

Material: Nitrile compound. Form factor: Finger-textured, blue, powder-free, non-sterile. Dimensions/Physical properties: Compliant with ASTM D6319-19. Biocompatibility: ISO 10993-5 (cytotoxicity Grade 2), ISO 10993-10 (non-irritant, non-sensitizer).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Suitable for over-the-counter use.

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

• LYDUS NITRILE EXAMINATION GLOVES, POWDER FREE (K203191)

Submission Summary (Full Text)

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November 5, 2021

Anhui Fine Glove Medical Technology Co., Ltd Johnson Liu Official Correspondent CNMED Consultant 31 Archer St Upper MT Gravatt, QLD 4122 Australia

Re: K212551

Trade/Device Name: Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 9, 2021 Received: August 13, 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.

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

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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)

#### K212551

Device Name Nitrile Examination Gloves

Indications for Use (Describe)

Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

#### Nitrile Examination Gloves

Preparation Date: Nov 6th, 2021

### 1. SUBMITTER

Company Name: ANHUI FINE GLOVE MEDICAL TECHNOLOGY CO., LT Company Address: Intersection of Feng Xiang Avenue and Gong Ye Road Chu Zhou Anhui, CN 233100 Contact Person: Johnson Liu Telephone Number: [phone] Email: [e-mail]

#### 2. NAME OF THE DEVICE

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

### 3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE

Predicate Device: K203191 Applicant: Nathan Trading Co., Ltd Device Name: LYDUS NITRILE EXAMINATION GLOVES, POWDER FREE Device Classification Name: Patient Examination Gloves Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZA Review Panel: General Hospital

### 4. DEVICE DESCRIPTION

The subject device in this 510(k) Notification is Nitrile Examination Gloves. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I) for single use only. The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

# 5. INDICATIONS FOR USE OF THE DEVICE

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

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

| CHARACTERISTICS | DEVICE PERFORMANCE | | REMARKS |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | SUBJECT | PREDICATE | |
| 510(k) Number | K212551 | K203191 | - |
| Device Name | Nitrile Examination Gloves | LYDUS Nitrile Examination Gloves, Powder Free | - |
| Product Code | LZA | LZA | Same |
| Indications for Use | Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner. The device is for over the-counter use. | LYDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. | Same |
| 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, Extra Large | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Usage | Single use | Single use | Same |
| Dimensions<br>(ASTM D6319-19) | Length Min. 230 min Width Min<br>95+/-10 mm (for medium size) | Length Min. 230 min Width Min<br>95+/-10 mm (for medium size) | Same |
| Physical Properties<br>(ASTM D6319-19) | <b>Before Aging</b><br>Tensile Strength<br>Min 14 Mpa Ultimate Elongation<br>Min 500%<br><b>After Aging</b><br>Tensile Strength<br>Min 14 Mpa Ultimate Elongation<br>Min 400% | <b>Before Aging</b><br>Tensile Strength<br>Min 14 Mpa Ultimate Elongation Min 500%<br><b>After Aging</b><br>Tensile Strength<br>Min 14 Mpa Ultimate Elongation Min 400% | Same |
| Thickness<br>(ASTM D6319-19) | Palm min 0.05 mm<br>Finger min 0.05 mm | Palm min 0.05 mm<br>Finger min 0.05 mm | Same |
| Powder Free<br>(ASTM D6319-19) | <2 mg/glove | <2 mg/glove | Same |
| Freedom from Holes<br>(Water Tight -1000 ml) -<br>ASTM D6319-19 (Cross<br>Reference D5151)AQL 2.5 | Passed | Passed | Same |
| Biocompatibility -<br>SKIN SENSITIZATION -<br>ISO 10993-10: 2010 (E) | Under the conditions of study, the<br>test article did not show significant<br>evidence of causing skin<br>sensitization in the guinea pig. | 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 the sample did not induce<br>skin irritation. | 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>cytotoxicity (Grade 2)<br>observed. It complied with the<br>criteria in ISO 10993-5:2009. | Exhibit cytotoxic<br>reactivity at 100%<br>extract concentration<br>(Grade 4 with neat extract).<br>Non-cytotoxic<br>reactivity at 50%, 25%,<br>12.5% and 6.25%<br>extract concentration. | Similar |
| Biocompatibility -<br>ACUTE SYSTEMIC<br>TOXICITY - ISO 10993-<br>11: 2017(E) | Not Tested | No systemic toxicity<br>under the experimental<br>conditions employed | Different¹ |
| Manufacturer(s) | ANHUI FINE GLOVE<br>MEDICAL TECHNOLOGY CO.,<br>LTD | Nathan Trading Co., Ltd | ----- |

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1 Justification: Based on the intended use of the subject device, the Biocompatibility- acute systemic toxicity testing was not required as per ISO 10993-1.

#### Conclusion:

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

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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 | Width:<br>80mm ±10mm (for small size)<br>95mm ±10mm (for medium size)<br>110 mm ±10mm (for large size)<br>Length:<br>220mm (Minimum) (for small size)<br>230 mm (Minimum)(for medium, large<br>size)<br>Thickness:<br>Finger -0.05 mm (Minimum) (for small,<br>medium, large size)<br>Palm -0.05 mm (Minimum)(for small,<br>medium, large size) | Width<br>small size<br>81 to 89mm<br>medium size<br>91 to 98mm<br>large size<br>109 to 111mm<br>Length<br>small size<br>230mm (minimum)<br>medium size<br>240mm (minimum)<br>large size<br>244mm (minimum)<br>Thickness<br>Finger<br>small size<br>0.12mm (minimum)<br>medium size<br>0.13mm (minimum)<br>large size<br>0.13mm (minimum)<br>Palm<br>small size<br>0.08mm (minimum)<br>medium size<br>0.08mm (minimum)<br>large size<br>0.08mm (minimum)<br>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>26 (Minimum)<br>Ultimate Elongation (%):<br>538 (Minimum)<br>After Acceleration Aging:<br>Tensile Strength (MPa):<br>25 (Minimum)<br>Ultimate Elongation (%):<br>511 (Minimum)<br>Passed |
| 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 | 0.4 mg/glove, Passed |

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#### BIO-COMPATIBILITY DATA

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

## 8. CLINICAL TESTING SUMMARY

Not applicable - Clinical data is not needed for gloves 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 Nitrile Examination Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device K203191- LYDUS Nitrile Examination Gloves, Powder Free.