Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

K211667 · Changzhou Universal Medical Equipment Co., Ltd. · LAZ · Sep 23, 2021 · Clinical Toxicology

Device Facts

• Record ID: K211667
• Device Name: Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
• Applicant: Changzhou Universal Medical Equipment Co., Ltd.
• Product Code: LAZ · Clinical Toxicology
• Decision Date: Sep 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

Disposable Medical Synthetic 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

Disposable synthetic nitrile and vinyl compound examination gloves; non-sterile; blue color; powder-free. Worn by healthcare personnel or patients to provide a barrier against contamination between the examiner and the patient's body, fluids, waste, or environment. Single-use device. Provides physical protection during medical examinations.

Clinical Evidence

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

Technological Characteristics

Material: Nitrile and vinyl compound. Form factor: Disposable, non-sterile, blue, powder-free gloves. Sizes: Small, Medium, Large. Standards: ASTM D6319-19 (physical dimensions, tensile strength, elongation, residual powder, freedom from holes). Biocompatibility: ISO 10993-5, ISO 10993-10.

Indications for Use

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

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Predicate Devices

• Synthetic Nitrile Patient Examination Gloves - Powder free, Blue Colour (K102593)

Submission Summary (Full Text)

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September 23, 2021

Changzhou Universal Medical Equipment Co. Ltd Johnson Liu Consultant CNMED Consultant 31 Archer St Upper MT Gravatt, QLD 4122 Australia

Re: K211667

Trade/Device Name: Disposable Medical Synthetic 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: LZA Dated: August 16, 2021 Received: August 24, 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, 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 Ouality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known)

K211667

Device Name

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

Indications for Use (Describe)

Disposable Medical Synthetic 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 K211667

#### DISPOSABLE MEDICAL SYNTHETIC NITRILE EXAMINATION GLOVES, NON-STERILE

Preparation Date: Aug 16th, 2021

#### 1. SUBMITTER

Company Name: Changzhou Universal Medical Equipment Co.,Ltd Company Address: No.6,Xinxi Road, Xinbei District Changzhou, CN 213000 Contact Person: Johnson Liu Telephone Number: [phone] Email: [e-mail]

#### 2. NAME OF THE DEVICE

Trade Name / Proprietary Name: Disposable Synthetic Nitrile Examination Gloves (Non Sterile) Device Name: Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) 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 PREDICATE DEVICE

Primary Predicate Device: K102593 Applicant: Zibo Yingbo Medical Products Co., Ltd Device Name: Synthetic Nitrile Patient Examination Gloves - Powder free, Blue Colour 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 Disposable Medical Synthetic Nitrile Examination Gloves. Non-sterile. The subject device is a patient examination glove made from nittile and vinyl 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.

# 5. INDICATIONS FOR USE OF THE DEVICE

Disposable Medical Synthetic Nitrile Examination Gloves, Non-sterile is 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 | | PRIMARY PREDICATE | Result |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | SUBJECT | | | |
| 510(k) Number | K211667 | | K102593 | - |
| Device Name | Disposable Medical Synthetic Nitrile Examination<br>Gloves Powder Free, Non sterile | | Synthetic Nitrile Patient Examination Gloves -<br>Powder free, Blue Color | - |
| Product Code | LZA | | LZA | Same |
| Indications for Use | Disposable Nitrile Examination Gloves Non-sterile<br>(Non sterile) is disposable devices intended for<br>medical purpose that are worn on the examiner's hand<br>to prevent contamination between patient and<br>examiner. The device is for over the-counter use. | | A patient examination glove is a disposable<br>device intended for medical purposes that is<br>worn on the hand of healthcare and similar<br>personnel to prevent contamination between<br>healthcare personal and the patient's body,<br>fluids, waste or environment | Same |
| Materials of Use | Nitrile and Vinyl compound | | Synthetic Nitrile | Similar |
| Color | Blue | | Blue | 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 | 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 size) | | Comply with ASTM D6319-05 | Same |
| Physical Properties | Before Aging<br>Tensile Strength<br>Min 14 Mpa<br>Ultimate Elongation Min 500%<br>After Aging<br>Tensile Strength<br>Min 14 Mpa<br>Ultimate Elongation Min 400%<br>(ASTM D6319-19) | | Before Aging<br>Tensile Strength<br>Min 14 Mpa<br>Ultimate Elongation Min 500%<br>After Aging<br>Tensile Strength<br>Min 14 Mpa<br>Ultimate Elongation Min 400%<br>(ASTM D6319-05) | Same |
| Thickness | Palm min 0.05 mm<br>Finger min 0.05 mm<br>(ASTM D6319-19) | Palm min 0.05 mm<br>Finger min 0.05 mm<br>(ASTM D6319-05) | Same | |
| Powder Free | <2 mg/glove (ASTM D6319-19) | <2 mg/glove (ASTM D6319-05) | Same | |
| Freedom from Holes (Water<br>Tight -1000 ml) AQL2.5 | Passed<br>ASTM D6319-19 (Cross Reference D5151 | Passed<br>ASTM D6319-05 (Cross Reference D5151) | Same | |
| Biocompatibility -SKIN<br>SENSITIZATION - ISO<br>10993-10: 2010 (E) | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Same | |
| Biocompatibility -SKIN<br>IRRITATION - ISO10993-<br>10: 2010 (E) | Under the conditions of study not an irritant | Under the conditions of study not an irritant | Same | |
| Biocompatibility - <i>IN VITRO</i><br>CYTOTOXICITY – ISO<br>10993-5: 2009(E) | Under the conditions of the cytotoxicity study, testing<br>results showed mild systemic toxicity and cytotoxic<br>level was 2. | No Testing Result available | Different | |
| Manufacturer(s) | Changzhou Universal Medical Equipment Co.,Ltd | Zibo Yingbo Medical Products Co., Ltd | -- | |

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To sum up, the subject device and predicate devices are equivalent in terms of intended use, design, safety and performance.

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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>80 mm (±10mm) (for small size)<br>95 mm (±10mm) (for medium size)<br>110 mm (±10mm) (for large size)<br>Length:<br>220 mm (Minimum)(for small size)<br>230 mm (Minimum)(for medium, large<br>size)<br>Thickness: (for all sizes)<br>Finger -0.05 mm (Minimum)<br>Palm -0.05mm (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): 14 (Minimum)<br>Ultimate Elongation (%): 500 (Minimum)<br>After Acceleration Aging:<br>Tensile Strength (MPa): 14 (Minimum)<br>Ultimate Elongation (%): 400(Minimum) | 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 | 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 | 0.6 mg/glove, Passed |

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#### BIO-COMPATIBILITY DATA

| Test Method | Purpose | Acceptance<br>Criteria | Result |
|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-10 Biological evaluation<br>of medical devices — Part 10: Tests<br>for skin irritation and skin<br>sensitization | To determine the potential of the<br>material under test to produce skin<br>irritation in rabbits | Under the condition of<br>study not an irritant | Under the<br>condition of study<br>not an irritant |
| ISO 10993-10 Biological evaluation<br>of medical devices — Part 10: Tests<br>for skin irritation and skin<br>sensitization | To determine the skin sensitization<br>potential of the material both in<br>terms of induction and elicitation in<br>guinea pigs. | Under the conditions of<br>the study not a sensitizer. | Under the condition<br>of the study not a<br>sensitizer. |
| ISO 10993-5 Biological evaluation of<br>medical devices — Part 5: Tests for in<br>vitro cytotoxicity | To evaluate the in vitro cytotoxic<br>potential of the test item (both inner<br>and outer surface) Extracts in L-929<br>mouse fibroblasts cells using elution<br>method | No more than grade 2<br>cytotoxicity at 100%<br>extract concentration | Under the conditions<br>of the cytotoxicity<br>study, the extract of<br>the test article<br>showed mild<br>cytotoxicity to L-929<br>cells and the<br>cytotoxic level was<br>2. |

## 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 Synthetic Nitrile Examination Gloves Non sterile is as safe, as effective, and performs as well as or better than the legally marketed predicate device K102593- Synthetic Nitrile Patient Examination Gloves – Powder free, Blue.