Nitrile Powder Free Examination Gloves

K220211 · Hebei Kangxida Medical Technology Development Co., Ltd. · LZA · May 18, 2022 · General Hospital

Device Facts

• Record ID: K220211
• Device Name: Nitrile Powder Free Examination Gloves
• Applicant: Hebei Kangxida Medical Technology Development Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: May 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Nitrile powder free examination gloves; disposable; worn on examiner's hand or finger; prevents contamination between patient and examiner. Used in clinical settings; operated by healthcare professionals. Device provides physical barrier protection. Benefits patient and examiner by reducing risk of cross-contamination during medical examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6319 (physical dimensions, physical properties), ASTM D5151 (watertightness/pinholes), and ASTM D6124 (residual powder). Biocompatibility testing conducted per ISO 10993-1, 10993-5 (cytotoxicity), 10993-10 (irritation/sensitization), and 10993-11 (systemic toxicity).

Technological Characteristics

Nitrile examination glove; blue color; ambidextrous; smooth surface. Available in Small, Medium, Large, X-large. Meets ASTM D6319-19, ASTM D5151-19, and ASTM D6124-06. Non-sterile. Biocompatible per ISO 10993 series.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

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

• Powder Free Nitrile Patient Examination Gloves, Blue Color (K120970)

Submission Summary (Full Text)

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May 18, 2022

Hebei kangxida Medical Technology Development Co., Ltd. % Bryan Wong Associate PureVision Ai Inc. 111 Town Square Place. Suite 1203 Jersey, New Jersey 07310

Re: K220211

Trade/Device Name: Nitrile Powder Free Examination Gloves (YK0001) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 29, 2022 Received: April 5, 2022

Dear Bryan Wong:

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.

Bifeng Qian, M.D., Ph.D. Acting 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

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# Indications for Use

510(k) Number (if known) K220211

Device Name

Nitrile Powder Free Examination Gloves (YK0001)

Indications for Use (Describe)

Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger 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 K220211

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

### 1. Submitter's Information

### Sponsor

- Company Name: Hebei Kangxida Medical Technology Development Co., Ltd. �
- Address: No. 5, Chuangye Avenue, Weixian Economic Development Zone, Handan City, Hebei � Province, China
- Phone: [phone] �
- � Email: [e-mail]
- � Contact Person (including title): Liu Xiaomin (General Manager)
- Date of Preparation: Jan. 24, 2022 �

### Application Correspondent:

- � PureFDA
- Address: 111 Town Square Place, Suite 1203 Jersey City, NJ 07310-2784 �
- Contact Person: Bryan Wong �
- Title: Associate �
- � Tel: [phone]
- � Email: [e-mail]

### 2. Subject Device Information

- � Type of 510(k) submission: Traditional
- Common Name: Patient Examination gloves �
- Classification Name: Non-powdered Patient examination glove �
- Trade Name: Nitrile Powder Free Examination Gloves �
- � Model: YK0001
- Review Panel: General Hospital �
- Product Code: LZA �
- Regulation Number: 21 CFR 880.6250 �
- � Requlation Class: I

### 3. Predicate Device Information

- 510(k) number: K120970 �
- � Sponsor: Tangshan Zhonghong Pulin Plastic Co., Ltd.

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- Common Name: Patient Examination gloves �
- Classification Name: Patient examination glove �
- Trade Name: Powder Free Nitrile Patient Examination Gloves, Blue Color �
- � Review Panel: General Hospital
- Product Code: LZA �
- Regulation Number: 21 CFR 880.6250 �
- Regulation Class: I �

### 4. Device Description

Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is in blue color, non-sterile and can be available in four specifications: Small, Medium, Large, X meets all of the requirements of ASTM standard D 6139-19.

### 5. Intended Use / Indications for Use

Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

#### 6. Comparison to predicate device

| Device | Proposed Device | Predicate Device | Comparison |
|----------------------|------------------------------------------------------------|---------------------------------------------------------------|------------|
| 510(K) | K220211 | K120970 | -- |
| Manufacturer | Hebei Kangxida Medical Technology<br>Development Co., Ltd. | Tangshan Zhonghong Pulin Plastic<br>Co., Ltd. | -- |
| Product Name | Nitrile Examination Gloves | Powder Free Nitrile Patient<br>Examination Gloves, Blue Color | -- |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Product Code | LZA | LZA | Same |
| Color | Blue | Blue | Same |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Surface Feature | Smooth | Smooth | Same |
| Intended Use/ | Nitrile powder free examination glove | Powder Free Nitrile Patient | Same |

#### Table 1-General Comparison

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| Indications for Use | is a disposable device intended for<br>medical purpose that is worn on the<br>examiner's hand or finger to prevent<br>contamination between patient and<br>examiner. | | | | Examination Glove, Blue Color is a<br>disposable device intended for medical<br>purposes that is worn on the<br>examiner's hand or finger to prevent<br>contamination between patient and<br>examiner. | | | | |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|--------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------------|-------------------|--|
| Device Description<br>and Specifications | Meets ASTM D6319- 19 | | | | Meets ASTM D6319- 10 | | | Same | |
| Dimensions-<br>Length<br>ILS-2 AQL4.0<br>(ASTM D6319) | ≥230mm min for Small sizes<br>≥240mm min for Medium / Large / X<br>large sizes | | | | Meets ASTM<br>D6319-10<br>≥230mm min | | | | |
| Dimensions-<br>Width<br>IL S-2 AQL4.0<br>(ASTM D6319) | Small | 85mm±10mm | | Small | 70-90 mm | | Similar | | |
| | Medium | 95mm±10mm | | Medium | 85-105mm | | Note 1 | | |
| | Large | 105mm±10mm | | Large | 100-120mm | | | | |
| | X large | 115mm±10mm | | X large | 110-130 mm | | | | |
| Dimensions-<br>Thickness<br>IL S-2 AQL4.0<br>(ASTM D6319) | Finger | Thickness (mm)<br>min. Finger 0.05 | | Finger | 0.05mm min | | | | |
| | Palm | Thickness (mm)<br>min. Palm 0.05 | | Palm | 0.05mm min. | | | | |
| | Before<br>Aging | Tensile<br>Strength | ≥14MPa | Before<br>Aging | Tensile<br>Strength | ≥14MPa | Similar<br>Note2 | | |
| Physical<br>Properties IL S-2<br>AQL4.0<br>(ASTM D6319) | | Ultimate<br>Elongation | ≥500% | | Ultimate<br>Elongation | ≥500% | | | |
| | After<br>Aging | Tensile<br>Strength | ≥14MPa | After<br>Aging | Tensile<br>Strength | ≥14MPa | | | |
| | | Ultimate<br>Elongation | ≥400% | | Ultimate<br>Elongation | ≥400% | | | |
| Freedom from<br>Pinholes<br>Inspection Level I<br>AQL2.5<br>(ASTM D5151-06) | Meets<br>• 21 CFR 800.20<br>• ASTM D6319-19 | | | | Meets<br>• 21 CFR 800.20<br>• ASTM D6319-10 | | | Same | |
| Residual Powder<br>(ASTM D 6124-06) | Meets ASTM<br>D 6124-06<br>(Reaffirmation 2011)<br>below 2mg of residual powder | | | | Meets ASTM<br>D 6124-06<br>(Reaffirmation 2011)<br>below 2mg of residual powder | | | | |
| Biocompatibility | Under the conditions of this study, the<br>test article was a non irritant , non<br>sensitizer and non Systemic Toxicity | | | | Under the conditions of this study, the<br>test article was a nonirritant or<br>nonsensitizer | | | Similar<br>Note 3 | |

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### Comparison in Detail(s):

### Note 1:

The difference in the dimensions does not raise additional questions for safety and effectiveness. All proposed devices are conducted the test according to ASTM D6319, the test results shown that the dimension of proposed device meet the requirements of standard.

### Note 2:

The difference in the physical properties does not raise additional questions for safety and effectiveness. Proposed devices are conducted the test according to ASTM D6319, the test results shown that the physical properties of proposed device meet the requirements of standard.

### Note 3:

Performance testing including biocompatibility evaluation has been performed on the proposed device. The test results shown that the performance of proposed device meet the requirements of standard and no potential biocompatibility issues.

### 7. Summary for non-clinical testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-1 Fifth edition 2018-08: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity

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

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| Test Method | Purpose | Acceptance Criteria | Results | | | |
|-------------|-----------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------|---------------------------|---------------------------------------------|
| ASTM D6319 | Physical<br>Dimensions Test | Length(mm)<br>Small: ≥230mm<br>Medium: ≥230mm<br>Large: ≥230mm<br>X large: ≥230mm | Length(mm)<br>Small: 231-238/Pass<br>Medium: 244-248/Pass<br>Large: 245-249/Pass<br>X large: 240-244/Pass | | | |
| | | Width(mm)<br>Small: 85±10mm<br>Medium: 95±10mm<br>Large: 110±10mm<br>X large: 115±10mm | Width(mm)<br>Small: 85-86/Pass<br>Medium: 96-97/Pass<br>Large: 106-108/Pass<br>X large: 113-114/Pass | | | |
| | | Thickness (mm)<br>Finger<br>Small: ≥0.05mm<br>Medium: ≥0.05mm<br>Large: ≥0.05mm<br>X large: ≥0.05mm | Thickness (mm)<br>Finger<br>Small: 0.097-0.111/Pass<br>Medium: 0.110-0.131/Pass<br>Large: 0.110-0.129/Pass<br>X large: 0.116-0.128/Pass | | | |
| | | Palm<br>Small: ≥0.05mm<br>Medium: ≥0.05mm<br>Large: ≥0.05mm<br>X large: ≥0.05mm | Palm<br>Small: 0.064-0.068/Pass<br>Medium: 0.065-0.069/Pass<br>Large: 0.060-0.065/Pass<br>X large: 0.059-0.066/Pass | | | |
| | | ASTM D5151 | Watertightness<br>Test for Detection<br>of Holes | No water leakage | 0/125/Pass | |
| | | ASTM D6124 | Powder Content | < 2mg | 0.3-0.4mg/Pass | |
| | | ASTM D6319<br>ASTM D412 | Physical properties | Before<br>Aging | Tensile Strength ≥14MPa | Meet the requirements of ASTM D6319 AQL 4.0 |
| | | | | | Ultimate Elongation ≥500% | Meet the requirements of ASTM D6319 AQL 4.0 |
| | | | | | | |
| | | | | After<br>Aging | Tensile Strength ≥14MPa | Meet the requirements of ASTM D6319 AQL 4.0 |
| | | | | | Ultimate Elongation ≥400% | Meet the requirements of ASTM D6319 AQL 4.0 |
| | | | | | | |

### Table 2 Summary of non-clinical performance testing

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| ISO 10993-5 | Cytotoxicity | Non- cytotoxicity | Under conditions of the study,<br>device extract is cytotoxic. |
|--------------|----------------------------|-----------------------------|------------------------------------------------------------------------------------------|
| ISO 10993-11 | Acute systemic<br>toxicity | Non-acute systemic toxicity | Under conditions of the study, did<br>not show acute systemic toxicity in<br>vivo / Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study,<br>not an irritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a<br>sensitizer./ Pass |

### 8. Summary for clinical test

Clinical performance is not deemed necessary.

## 9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device Nitrile Powder Free Examination Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device K120970.