Nitrile Examination Gloves

K212922 · Hsk Medical Apparatus Foshan China Co., Ltd. · LZA · Dec 10, 2021 · General Hospital

Device Facts

• Record ID: K212922
• Device Name: Nitrile Examination Gloves
• Applicant: Hsk Medical Apparatus Foshan China Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination glove; non-sterile; ambidextrous; blue color; available in S, M, L, XL sizes. Used by healthcare examiners to provide a barrier against contamination between patient and examiner. Device functions as a physical barrier; no electronic or active components. Performance verified through physical property testing (tensile strength, elongation, hole detection) and biocompatibility assessment.

Clinical Evidence

Bench testing only. No clinical data required. Testing included physical dimensions (ASTM D6319), watertightness/hole detection (ASTM D5151, AQL 2.5), residual powder (ASTM D6124), physical properties (ASTM D412), and biocompatibility (ISO 10993-5, -10, -11). All results met acceptance criteria.

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, non-sterile, powder-free glove. Dimensions and physical properties comply with ASTM D6319-19. Biocompatibility per ISO 10993-5, 10, and 11. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a non-sterile, disposable medical glove worn on the examiner's hands or fingers 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

• Disposable Powder Free Nitrile Examination Glove, White/Blue/ Black/ Pink Color (K171422)

Submission Summary (Full Text)

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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.

December 10, 2021

HSK Medical Apparatus Foshan China Co. LTD Boyle Wang Official Correspondent Shanghai Truthful information Technology Co., Ltd. RM. 1801.No. 161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K212922

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: September 2, 2021 Received: September 14, 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.

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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, 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) K212922

Device Name Nitrile Examination Gloves

Indications for Use (Describe)

The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands 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 K212922

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

#### 1.0 Submitter's Information

Name: HSK Medical Apparatus Foshan China Co. LTD Address: Shitang Road, Shishan Town, Nanhai District, Foshan, Guangdong, China. Phone Number: [phone] Contact: Zhao Zhongheng Date of Preparation: Sept.2, 2021

#### Designated Submission Correspondent

Mr. Boyle Wanq 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 Examination Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M, L, XL

#### 3.0 Classification

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

#### 4.0 Predicate Device Information

Manufacturer: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/Blue/ Black/ Pink Color 510(k) number: K171422

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#### 5.0 Indication for Use

The Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

#### 6.0 Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

## 7.0 Technological Characteristic Comparison Table

| Table1-General Comparison | | | | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|------|
| Item | Subject Device<br>(K212922) | Predicated Device<br>(K171422) | Remark | |
| Product Code | LZA | LZA | Same | |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same | |
| Class | I | I | Same | |
| Intended Use | The Disposable Nitrile<br>Examination Glove is a<br>non-sterile disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hands or finger to<br>prevent contamination<br>between patient and<br>examiner. | The Nitrile Powder Free<br>patient examination<br>glove is a non-sterile<br>disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hands or<br>finger to prevent<br>contamination between<br>patient and examiner. | Same | |
| Material | Nitrile | Nitrile | Same | |
| Powdered or<br>Powered free | Powdered free | Powdered free | Same | |
| Design Feature | Ambidextrous | Ambidextrous | Same | |
| Colorant | Blue | White/Blue/ Black/ Pink | Different<br>Analysis 1 | |
| Labeling<br>Information | Single-use indication,<br>powder free, device<br>color, device name,<br>glove size and quantity,<br>Non-Sterile | Single-use indication,<br>powder free, device<br>color, device name,<br>glove size and quantity,<br>Non-Sterile | Same | |
| Dimensions(mm) | Length:<br>S: ≥220;<br>M/L/XL: ≥230. | Length:<br>XS/S/M/L/XL: ≥230;<br>Width: | Different<br>Analysis 2 | |
| | Width: | XS: 87±5; | | |
| | S: 80±10; | S: 85±5; | | |
| | M: 95±10; | M: 95±5; | | |
| | L: 110±10; | L: 105±5; | | |
| | XL: 120±10 | XL: 115±5 | | |
| Thickness(mm) | | Finger: ≥0.05; | Finger: ≥0.05; | Same |
| | | Palm: ≥0.05 | Palm: ≥0.05 | |
| Physical<br>Properties | Before<br>Aging | Tensile<br>Strength | 14MPa,<br>min | Same |
| | | Ultimate<br>Elongation | 500% min | Same |
| | After<br>Aging | Tensile<br>Strength | 14MPa,<br>min | Same |
| | | Ultimate<br>Elongation | 400%min | Same |
| Freedom from<br>Holes | | Be free from holes when<br>tested in accordance<br>with ASTMD5151<br>AQL=2.5 | | Same |
| | | Be free from holes when<br>tested in accordance<br>with ASTMD5151<br>AQL=2.5 | | |
| Powder Content | | Meet the requirements of<br>ASTM D6124 | | Same |
| Biocompatibility | | ISO 10993-5<br>Under conditions of the<br>study, device extract is<br>cytotoxic | | / |
| | | ISO 10993-10;<br>Under the conditions of<br>the study, not an irritant<br>or a sensitizer | | Same |
| | | ISO 10993-11;<br>Under the<br>condition of acute<br>systemic toxicity test,<br>the test article did not<br>show acute systemic<br>toxicity in vivo. | | / |
| | | N.A. | | |
| | | N.A. | | |

#### Table1-General Comparison

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Analysis 1: The subject device (Blue) has different color to the predicate device (White/ Blue/ Black/ Pink), but all proposed devices are conducted the biocompatibility test.

Analysis 2: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319.

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#### 8.0 Summary of 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 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

ISO 10993-11:2017, 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.

| Test<br>Method | Purpose | Acceptance Criteria | Results |
|----------------|--------------------------------|---------------------|------------------------|
| ASTM<br>D6319 | Physical<br>Dimensions<br>Test | Length(mm): | Length(mm): |
| | | S: ≥220; | S/M/L/XL: > 230/Pass; |
| | | M/L/XL: ≥230; | Width(mm): |
| | | Width(mm): | S: 80-90 /Pass |
| | | S: 80±10; | M: 85-96/ Pass |
| | | M: 95±10; | L: 101-115/ Pass |
| | | L: 110±10; | XL:110-122/ Pass |
| | | XL: 120±10 | |
| | | Thickness (mm): | Thickness (mm): |
| | | Finger: ≥0.05 | S: |
| | | Palm: ≥0.05 | Finger: 0.08-0.15/Pass |
| | | | Palm: 0.07-0.08/Pass |
| | | | M: |
| | | | Finger: 0.10-0.18/Pass |
| | | | Palm: 0.07-0.11/Pass |
| | | | L: |

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

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| | | | | Finger: 0.11-0.18/Pass<br>Palm: 0.07-0.08/Pass | |
|-----------------|-----------------------------------------------------|------------------------------------------------|------------------------|---------------------------------------------------------------------------------------------|----------------|
| | | | | XL:<br>Finger: 0.11-0.13/Pass<br>Palm: 0.07-0.08/Pass | |
| ASTM<br>D5151 | Watertightness<br>Test for<br>Detection of<br>Holes | Meet the requirements of ASTM D5151<br>AQL 2.5 | | 0/125/Pass | |
| ASTM<br>D6124 | Powder<br>Content | Meet the requirements of ASTM D6124 < 2.0mg | | 0.12-0.15mg/Pass; | |
| ASTM<br>D412 | Physical<br>properties | Before<br>Aging | Tensile<br>Strength | ≥14MPa | 16-30MPa/Pass; |
| | | | Ultimate<br>Elongation | ≥500% | 500-549%/Pass; |
| | | After<br>Aging | Tensile<br>Strength | ≥14MPa | 14-26MPa/Pass; |
| | | | Ultimate<br>Elongation | ≥400% | 435-525%/Pass; |
| | | ISO<br>10993-5 | Cytotoxicity | In Vitro Cytotoxicity Test | |
| ISO<br>10993-11 | Cytotoxicity | Non- acute systemic<br>toxicity | | Under conditions of<br>the study, did not<br>show acute systemic<br>toxicity in vivo / Pass | |
| ISO<br>10993-10 | Irritation | Non-irritating | | Under the conditions<br>of the study, not an<br>irritant/ Pass | |
| ISO<br>10993-10 | Sensitization | Non-sensitizing | | Under conditions of<br>the study, not a<br>sensitizer / Pass | |

# 9.0 _Summary of Clinical Testing

Clinical testing is not needed for this device.

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#### 10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device Disposable Nitrile Examination Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicated device in K171422.