USA Gloves Nitrile Powder Free Exam Gloves

K211624 · Usa Gloves · LZA · Dec 18, 2021 · General Hospital

Device Facts

• Record ID: K211624
• Device Name: USA Gloves Nitrile Powder Free Exam Gloves
• Applicant: Usa Gloves
• Product Code: LZA · General Hospital
• Decision Date: Dec 18, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination glove; worn by healthcare examiners to provide barrier protection against contamination between patient and examiner. Device is non-sterile, single-use, and powder-free. No electronic, mechanical, or software components. Used in clinical settings; provides physical barrier to prevent transmission of pathogens or contaminants during patient examinations.

Clinical Evidence

Bench testing only. No clinical data. Device performance evaluated against ASTM D6319-10 standards for physical properties (tensile strength, elongation), dimensions, thickness, and powder residue. Biocompatibility evaluated per ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin irritation), and ISO 10993-11 (acute systemic toxicity). All tests passed.

Technological Characteristics

Nitrile rubber examination glove. Non-powdered. Non-sterile. Dimensions and physical properties comply with ASTM D6319-10 (reapproved 2015). Thickness: min 0.05 mm (palm/finger). Tensile strength: min 14 MPa (before/after aging). Ultimate elongation: min 500% (before aging), 400% (after aging). Powder residue: <2 mg/glove. Biocompatibility: ISO 10993-5, 10, 11 compliant.

Indications for Use

Indicated for use as a disposable, non-sterile, powder-free patient examination 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

• Blue Nitrile Examination Gloves Powder free (K202384)

Reference Devices

• K192333

Submission Summary (Full Text)

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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.

December 18, 2021

USA Gloves Zishan Momin Chief Operating Office 12505 Reed Rd Ste 110 Sugar Land, Texas 77478

Re: K211624

Trade/Device Name: USA Gloves Nitrile Powder Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 16, 2021 Received: November 16, 2021

Dear Zishan Momin:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K211624

Device Name

USA Gloves Nitrile Powder Free Exam Gloves

Indications for Use (Describe)

Intended for medical purpose that are 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)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for USA Gloves. The logo features a blue hand with a white star on the palm, and red stripes on the fingers, resembling the American flag. Below the hand is the text "USA GLOVES" in blue, and below that is the text "AMERICAN MADE NITRILE GLOVES" in red.

May 16, 2021

Zishan Momin Tel: [phone] Email: [e-mail]

# 510(K) Summary - K211624

### Submitter Information

| FDA 510(K) K211624 | |
|---------------------------------------|------------------------------------------------------|
| Product/Trade Name | USA Gloves Nitrile Powder Free Exam Gloves |
| 510(K) | K211624 |
| Applicant Name: | Glove Ventures LLC<br>dba USA Gloves |
| Applicant Address (city, state, zip): | Stafford, TX 77477 |
| Applicant Contact Person: | Zishan Momin |
| Correspondent Name: | Zishan Momin |
| Correspondent Address (full address): | 12505 Reed Rd Ste 110<br>Sugar Land, TX 77478<br>USA |
| Correspondent Contact Person: | Zishan Momin |
| Correspondent Contact Phone#: | |
| Correspondent Contact Email: | [e-mail] |

### Predicate Devices

The USA Gloves Nitrile Powder Free Exam Gloves is identical to the Hi-Care Thai Gloves Co. Ltd. Blue Nitrile Examination Gloves Powder free which is the subject of a clearance letter from the Agency under 510(k) number K202384, which itself, was predicated on the subject of K192333. The predicate Hi-Care Thai Gloves Co. Ltd. Blue Nitrile Examination Gloves Powder free and USA Gloves Global Nitrile Gloves are the same in design and use.

### Indications for Use:

USA Gloves Nitrile Powder Free Exam Gloves is intended as a powder-free patient examination glove and 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. The USA Gloves Nitrile Powder Free Exam Gloves is a single use, disposable device, provided non-sterile.

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## Device Description:

USA Gloves Nitrile Gloves and aforementioned predicate device are Non-powdered patient examination glove, as defined in 21 CFR 880.6250.

Former Release Powder or Chemical: No release powder or chemical is used.

USA Gloves Nitrile Gloves is not intended to be sterilized. The device is delivered in packaging which may be used as a protective carrying case.

| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison |
|------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | Subject | Predict | |
| 510(K) Number | | K211624 | K202384 | ---- |
| Name of device | | USA Gloves Nitrile<br>Powder Free Exam<br>Glove | Blue Nitrile<br>Examination Gloves<br>Powder free | ---- |
| Product Code | | LZA | LZA | ---- |
| Dimensions | ASTMD 6319-10<br>(Reapproved 2015) | Length Min 230 m<br>Width Min 95+/-10mm<br>(for medium size) | Length Min 230 mm<br>Width Min 95+/mm<br>(for medium size) | Same |
| Physical Properties | ASTMD 6319-10<br>(Reapproved 2015) | Before Aging<br>Tensile Strength min<br>14 Mpa<br>Ultimate Elongation<br>Min 500%<br>After Aging<br>Tensile Strength<br>min 14 Mpa<br>Ultimate<br>Elongation<br>Min 400% | Before Aging<br>Tensile Strength min<br>14 Mpa<br>Ultimate Elongation<br>Min 500%<br>After Aging<br>Tensile Strength min<br>14 Mpa<br>Ultimate Elongation<br>Min 400% | Same |
| Thickness | ASTMD<br>6319-10<br>(Reapproved 2015) | Palm min 0.05 mm Finger<br>min 0.05 mm | Palm min 0.05 mm<br>Finger min 0.05 mm | Same |
| Powder Residue | ASTMD 6319-10 | <2 mg/glove | <2 mg/glove | Same |
| Primary Skin<br>Irritation-<br>ISO<br>10993-<br>10:2010(E) | | Under the condition of<br>study not an irritant | Under the condition<br>of study not an<br>irritant | Same |

## Technological Characteristics Comparison Table

Table1: USA Gloves Nitrile Gloves / the Hi-Care Thai Gloves Co. Ltd. Blue Nitrile Examination Gloves Powder Free Comparison

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## Summary of Nonclinical Testing

Provided below is a summary of the standards and test methodology that was used to evaluate and demonstrate that the subject device met the performance specification and acceptance criteria for a nitrile glove.

| Test Methodology | Purpose | Acceptance Criteria | Results |
|------------------------------------|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ASTMD 6319-10<br>(Reapproved 2015) | Physical Properties | Before Aging Tensile Strength min<br>14 Mpa Ultimate Elongation Min<br>500% After Aging Tensile Strength<br>min 14 Mpa Ultimate Elongation<br>Min 400% | Pass |
| ASTMD 6319-10<br>(Reapproved 2015) | Dimensions | Length Min 230 m Width Min<br>95+/-10mm (for medium size) | Pass |
| ASTMD 6319-10<br>(Reapproved 2015) | Thickness | Palm min 0.05 mm Finger min 0.05<br>mm | Pass |
| ASTMD 6319-10<br>(Reapproved 2015) | Powder Residue | $<$ 2 mg/glove | Pass |
| ISO 10993-5 | Biocompatibility-<br>Cytotoxicity | No Cytotoxicity | Pass |
| ISO 10993-10 | Skin Irritation | No Skin Irritation | Pass |
| ISO 10993-11 | Acute Systemic<br>Toxicity | No Systemic Toxicity | Pass |

## Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.