Powder Free Nitrile Gloves

K213448 · St Future International Limited · LZA · Jun 6, 2022 · General Hospital

Device Facts

• Record ID: K213448
• Device Name: Powder Free Nitrile Gloves
• Applicant: St Future International Limited
• Product Code: LZA · General Hospital
• Decision Date: Jun 6, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. This device is a disposable product, provided non-sterile.

Device Story

Non-sterile, disposable nitrile examination gloves; blue color; available in S, M, L, XL sizes. Function as physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings by healthcare providers. Device provides protection during patient examinations. Manufactured to meet ASTM D6319-19 standards for physical dimensions and properties.

Clinical Evidence

No clinical testing performed. Evidence based on non-clinical bench testing including physical properties (tensile strength, elongation), freedom from pinholes (ASTM D5151-19), residual powder (ASTM D6124-06), and biocompatibility (ISO 10993-5, 10, 11).

Technological Characteristics

Material: Nitrile. Form factor: Disposable, non-sterile, blue, powder-free glove. Standards: ASTM D6319-19 (dimensions/physical properties), ASTM D5151-19 (pinholes), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-5, 10, 11. Shelf-life: 3 years (validated via ASTM D7160-16).

Indications for Use

Indicated for use as a disposable, non-sterile patient examination glove worn on the examiner's hands to prevent 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

• Blue Nitrile Powder Free Patient Examination Glove, Non Sterile (K210366)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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.

June 6, 2022

St Future International Limited % Bing Huang Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road ShenZhen, GuangDong 518100 China

Re: K213448

Trade/Device Name: Powder Free Nitrile Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 28, 2022 Received: May 5, 2022

Dear Bing Huang:

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.

{1}------------------------------------------------

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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K213448

Device Name Powder Free Nitrile Gloves

Indications for Use (Describe)

The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

This device is a disposable product, provided non-sterile.

| 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510 (k) Summary

This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.

# K213448

# (1) Applicant information:

| 510(k) owner's name: | ST FUTURE INTERNATIONAL LIMITED |
|---------------------------|------------------------------------------------------------------------------|
| Address: | FLAT/RM 08 9/F CHEVALIER COMMERCIAL CENTRE 8<br>WANG HOT ROAD KOWLOON BAY HK |
| Contact person: | Ivan Tan |
| Phone number: | [phone] |
| Email: | [e-mail] |
| Date of summary prepared: | 2022-6-2 |

#### (2) Proprietary name of the device

| Trade name/model: | Powder Free Nitrile Gloves |
|--------------------|-----------------------------------|
| Common name: | Polymer Patient Examination Glove |
| Regulation number: | 21 CFR 880.6250 |
| Product code: | LZA |
| Review panel: | General Hospital |
| Regulation class: | Class I |

#### (3) Predicate device

| | Predicate device |
|-----------------------|-----------------------------------------------------------------|
| Sponsor | Onetexx Sdn Bhd |
| Device Name and Model | Blue Nitrile Powder Free Patient Examination Glove, Non Sterile |
| 510(k) Number | K210366 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Regulation Class | Class I |

## (4) Description/ Design of device:

The Powder Free Nitrile Gloves are non-sterile disposable patient examination gloves. The gloves are blue and powder free. The Powder Free Nitrile Gloves come in four sizes: Small, Medium, Large, X Large.

The Powder Free Nitrile Gloves act as a barrier to prevent contamination between patient and

{4}------------------------------------------------

examiner. The device meets all requirements of ASTM D6319-19.

#### (5) Indications for use:

The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

This device is a disposable product, provided non-sterile.

#### (6) Materials

| Product name | Material of product | Color additives | Body contract category | Contact duration |
|-------------------------------|---------------------|-----------------|----------------------------------------------|--------------------|
| Powder Free<br>Nitrile Gloves | Nitrile | Blue | Surface and external<br>communicating device | Less than 24 hours |

## (7) Technological Characteristic Comparison Table

| Item | Subject device | Predicate device | Remark |
|--------------------------------------|---------------------------------------------------|------------------------------------------------------------|-------------------------------------------|
| Company | ST FUTURE | Onetexx Sdn Bhd | / |
| | INTERNATIONAL | | |
| | LIMITED | | |
| Trade name | Powder Free Nitrile Gloves | Blue Nitrile Powder Free | / |
| | | Patient Examination Glove, | |
| | | Non Sterile | |
| 510 (k) number | K213448 | K210366 | / |
| Regulation number | 21CFR 880.6250 | 21 CFR 880.6250 | Same |
| Product code | LZA | LZA | Same |
| Size | S/ M/ L/ XL | Extra Small/ Small/ Medium/ | Same |
| | | Large/ Extra Large | |
| Class | I | I | Same |
| Indications for use/<br>Intended use | The Powder Free Nitrile<br>Gloves is intended for | A patient examination glove<br>is a disposable device made | Similar,<br>only<br>wording<br>difference |
| | medical purposes that is | of synthetic rubber latex | |
| | worn on the examiner's | intended for medical purposes | |
| | hands to prevent | that is worn on the examiner's | |
| | contamination between | hand or finger to prevent | |
| | patient and examiner. | contamination between | |
| | This device is a disposable | patient and examiner. | |
| | product, provided | | |
| | non-sterile. | | |
| | | | |

{5}------------------------------------------------

# ST FUTURE INTERNATIONAL LIMITED
510(k)s – Section 1. 510 (k) Summary

| Dimensions: | | | | | |
|--------------------------------------------|--------|--------|-------------------------------------|-------------------------------------|----------------------------------------|
| S | Length | | 246mm | 249mm | Different<br>but within the ASTM D6319 |
| | Width | | 86.4mm | 87.0mm | |
| | Thic | Finger | 0.11mm | 0.10mm | |
| | kness | Palm | 0.08mm | 0.07mm | |
| M | Length | | 243mm | 249mm | |
| | Width | | 96.9mm | 98.0mm | |
| | Thic | Finger | 0.12mm | 0.10mm | |
| | kness | Palm | 0.09mm | 0.07mm | |
| L | Length | | 255mm | 248mm | |
| | Width | | 106mm | 107mm | |
| | Thic | Finger | 0.12mm | 0.10mm | |
| | kness | Palm | 0.09mm | 0.07mm | |
| X<br>L | Length | | 251mm | 250mm | |
| | Width | | 116mm | 117mm | |
| | Thic | Finger | 0.12mm | 0.10mm | |
| | kness | Palm | 0.08mm | 0.07mm | |
| Physical Properties: | | | | | |
| | | | | | Different<br>but within the ASTM D6319 |
| Before Aging<br>Tensile strength | | | 34.56MPa | 32.35MPa | |
| Ultimate elongation | | | 556% | 568% | |
| | | | | | |
| After Aging<br>Tensile strength | | | 36.34MPa | 36.10MPa | |
| Ultimate elongation | | | 485% | 551% | |
| Freedom from<br>Pinholes Holes | | | In accordance with ASTM<br>D5151-19 | In accordance with ASTM<br>D5151-19 | Same |
| | | | Inspection level: G-1<br>AQL=2.5 | Inspection level: G-1<br>AQL=2.5 | |
| | | | | | |
| Residual Powder | | | 0.3mg/glove | 0.24mg/glove | Different<br>but within the ASTM D6124 |
| | | | | | |
| | | | | | |
| Materials used to<br>fabricate the devices | | | Nitrile | Nitrile | Same |
| | | | | | |
| Color | | | Blue | Blue | Same |

{6}------------------------------------------------

| Compare<br>performance data<br>supporting<br>substantial<br>equivalence | Meets ASTM D5151-19<br>ASTM D6319-19<br>ASTM D6124-06<br>(Reapproved 2017) | Meets ASTM D5151-19<br>ASTM D6319-19<br>ASTM D6124-06<br>(Reapproved 2017) | Same | |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------|
| Single Use | Single Use | Single Use | Same | |
| Biocompatibility | Under the conditions of this<br>study, the test article extract<br>showed no significant<br>evidence of causing skin<br>sensitization in the guinea<br>pig. Complies with ISO<br>10993-10:2010. | The test material did not<br>produce a skin sensitization<br>effect in the guinea pigs.<br>Complies with ISO<br>10993-10:2010. | Same | |
| | The test result showed that<br>the irritant response of the<br>test article extract was<br>categorized as negligible<br>under the test condition.<br>Complies with ISO<br>10993-10:2010. | The test material did not<br>cause an irritant response.<br>The Primary Irritant<br>Response Category is deemed<br>'Negligible'. Complies with<br>ISO 10993-10:2010. | Same | |
| | According to ISO 10993-5:<br>2009, the test material<br>demonstrated a cytotoxic<br>effect under the condition of<br>this study. Additional test<br>i.e. Acute Systemic Toxicity<br>was tested. | According to ISO 10993-5:<br>2009, the test material<br>demonstrated a cytotoxic<br>effect under the condition of<br>this study. Additional test i.e.<br>Acute Systemic Toxicity was<br>tested. | Same | |
| | Under the conditions of this<br>study, there was no<br>evidence of systemic<br>toxicity from the extract.<br>Complies with ISO<br>10993-11:2017 | The test item did not induce<br>any systemic toxicity.<br>Complies with ISO 10993-<br>11:2017 | Same | |
| | Shelf-life | 3 years | Not known | Different |

Note 1: Although the shelf-life data of the predicate device are unknown, but the subject device has been validated to the shelf-life of 3 years, so the difference does not affect safety and effectiveness.

{7}------------------------------------------------

## (8) Summary of Non-Clinical Testing:

Powder Free Nitrile Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standard.

| Characteristics | Standard | Result | |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Dimension | ASTM D6319-19 | | |
| | Small | | |
| | Length | $\geq220mm$ | 246mm |
| | Width | 80±10mm | 86.4mm |
| | Thickness Finger | $\geq0.05mm$ | 0.11mm |
| | Palm | $\geq0.05mm$ | 0.08mm |
| | Medium | | |
| | Length | $\geq230mm$ | 243mm |
| | Width | 95±10mm | 96.9mm |
| | Thickness Finger | $\geq0.05mm$ | 0.12mm |
| | Palm | $\geq0.05mm$ | 0.09mm |
| | Large | | |
| | Length | $\geq230mm$ | 255mm |
| | Width | 110±10mm | 106mm |
| | Thickness Finger | $\geq0.05mm$ | 0.12mm |
| | Palm | $\geq0.05mm$ | 0.09mm |
| | X large | | |
| | Length | $\geq230mm$ | 251mm |
| | Width | 120±10mm | 116mm |
| | Thickness Finger | $\geq0.05mm$ | 0.12mm |
| | Palm | $\geq0.05mm$ | 0.08mm |
| Physical Properties | ASTM D6319-19 | | |
| | Before aging | Tensile strength $\geq14MPa$ | 34.56MPa |
| | | Ultimate elongation $\geq500%$ | 556% |
| | After aging | Tensile strength $\geq14MPa$ | 36.34MPa |
| | | Ultimate elongation $\geq400%$ | 485% |
| Freedom from pinholes | ASTM D5151-19 | Pass, no water leakage<br>Passed Standard Acceptance Criteria, AQL=2.5 | |
| Powder Residual | ASTM D6319-19 and ASTM D6124-06 (Reapproved 2017) | Meets < 2.0 mg/ glove 0.3mg/glove | |
| Biocompatibility | In vitro cytotoxicity ISO 10993-5:2009 | Cytotoxic. Additional test i.e. Acute Systemic Toxicity was tested.<br>The test material demonstrated a cytotoxic effect under the condition of this study | |
| Acute Systemic Toxicity of Powder<br>Free Nitrile Gloves ISO 10993-11:<br>2017 | Under the conditions of<br>this study, there was no<br>evidence of systemic<br>toxicity from the<br>extract. The test article<br>extract met the<br>requirements of the<br>study. | Pass | |
| Skin Irritation ISO 10993-10: 2010 | The test result showed<br>that the response of the<br>test article extract was<br>categorized as<br>negligible under the<br>test condition. | Pass | |
| Skin sensitization in the guinea pig<br>ISO 10993-10: 2010 | Under the conditions of<br>this study, the test<br>article extract showed<br>no significant evidence<br>of causing skin<br>sensitization in the<br>guinea pig. | Pass | |
| Shelf-life | ASTM D7160-16<br>The study are<br>following the table 1<br>lists three conditions<br>(0, 50 oC ,70 oC ) for<br>accelerate aging<br>testing. | Pass and met 3<br>years of shelf-<br>life. | |

{8}------------------------------------------------

The Powder Free Nitrile Gloves meet requirements per ASTM D6319-19, per ASTM D 5151-19, per ASTM D6124-06 (Reapproved 2017), ISO 10993-11: 2017 and ISO 10993-10: 2010.

## (9) Summary of Clinical Testing

Clinical performance testing was not needed for this device.

#### (10) Conclusion

Based on the nonclinical tests performed, the subject device, Powder Free Nitrile Gloves, are as safe, as effective, and perform as well as the legally marketed predicate device, K210366, Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile.